An Internet-Based Guided Self-Help Intervention for Panic Symptoms: Randomized Controlled Trial

Background

Internet-based guided self-help is efficacious for panic disorder, but it is not known whether such treatment is effective for milder panic symptoms as well.

Objective

To evaluate the effectiveness of Don’t Panic Online, an Internet-based self-help course for mild panic symptoms, which is based on cognitive behavioral principles and includes guidance by email.

Methods

A pragmatic randomized controlled trial was conducted. Participants (N=126) were recruited from the general population and randomized to either the intervention group or to a waiting-list control group. Inclusion criteria were a Panic Disorder Severity Scale-Self Report (PDSS-SR) score between 5-15 and no suicide risk. Panic symptom severity was the primary outcome measure; secondary outcome measures were anxiety and depressive symptom severity. Measurements were conducted online and took place at baseline and 12 weeks after baseline (T1). At baseline, diagnoses were obtained by telephone interviews.

Results

Analyses of covariance (intention-to-treat) showed no significant differences in panic symptom reduction between groups. Completers-only analyses revealed a moderate effect size in favor of the intervention group (Cohen’s d=0.73, P=.01). Only 27% of the intervention group finished lesson 4 or more (out of 6). Nonresponse at T1 was high for the total sample (42.1%). Diagnostic interviews showed that many participants suffered from comorbid depression and anxiety disorders.

Conclusions

The Internet-based guided self-help course appears to be ineffective for individuals with panic symptoms. However, intervention completers did derive clinical benefits from the intervention.

Trial Registration

Nederlands Trial Register: NTR1639; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1639 (Archived by WebCite at http://www.webcitation.org/6ITZPozs9).     

Rethinking the Dose-Response Relationship Between Usage and Outcome in an Online Intervention for Depression: Randomized Controlled Trial

Background

There is now substantial evidence that Web-based interventions can be effective at changing behavior and successfully treating psychological disorders. However, interest in the impact of usage on intervention outcomes has only been developed recently. To date, persistence with or completion of the intervention has been the most commonly reported metric of use, but this does not adequately describe user behavior online. Analysis of alternative measures of usage and their relationship to outcome may help to understand how much of the intervention users may need to obtain a clinically significant benefit from the program.

Objective

The objective of this study was to determine which usage metrics, if any, are associated with outcome in an online depression treatment trial.

Methods

Cardiovascular Risk E-couch Depression Outcome (CREDO) is a randomized controlled trial evaluating an unguided Web-based program (E-couch) based on cognitive behavioral therapy and interpersonal therapy for people with depression and cardiovascular disease. In all, 280 participants in the active arm of the trial commenced the program, delivered in 12 modules containing pages of text and activities. Usage data (eg, number of log-ins, modules completed, time spent online, and activities completed) were captured automatically by the program interface. We estimated the association of these and composite metrics with the outcome of a clinically significant improvement in depression score on the Patient Health Questionnaire (PHQ-9) of ≥5 points.

Results

In all, 214/280 (76.4%) participants provided outcome data at the end of the 12-week period and were included in the analysis. Of these, 94 (43.9%) participants obtained clinically significant improvement. Participants logged into the program an average of 18.7 times (SD 8.3) with most (62.1%, 133/214) completing all 12 modules. Average time spent online per log-in was 17.3 minutes (SD 10.5). Participants completed an average of 9 of 18 activities available within the program. In a multivariate regression model, only the number of activities completed per log-in was associated with a clinically significant outcome (OR 2.82, 95% CI 1.05-7.59). The final model predicted 7.4% of variance in outcome. Curve estimates indicated that significant logarithmic (P=.009) and linear (P=.002) relationships existed between activities completed per log-in and clinically significant change.

Conclusions

Only one objective measure of usage was independently associated with better outcome of a Web-based intervention of known effectiveness. The 4 usage metrics retained in the final step of the regression accounted for little outcome variance. Medium level users appeared to have little additional benefit compared to low users indicating that assumptions of a linear relationship between use and outcome may be too simplistic and further models and variables need to be explored to adequately understand the relationship.

Trial Registration

Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000085077; http://www.anzctr.org.au/ACTRN12610000085077.aspx (Archived by WebCite at http://www.webcitation.org/6K9FQtKBn).     

Internet-Based,Culturally Sensitive,Problem-Solving Therapy for Turkish Migrants With Depression: Randomized Controlled Trial

Background

Turkish migrants living in the Netherlands have a high prevalence of depressive disorders, but experience considerable obstacles to accessing professional help. Providing easily accessible Internet treatments may help to overcome these barriers.

Objective

The aim of this study was to evaluate the effectiveness of a culturally sensitive, guided, self-help, problem-solving intervention through the Internet for reducing depressive symptoms in Turkish migrants.

Methods

A two-armed randomized controlled trial was conducted. The primary outcome measure was the severity of depressive symptoms; secondary outcome measures were somatic symptoms, anxiety, quality of life, and satisfaction with the treatment. Participants were assessed online at baseline, posttest (6 weeks after baseline), and 4 months after baseline. Posttest results were analyzed on the intention-to-treat sample. Missing values were estimated by means of multiple imputation. Differences in clinical outcome between groups were analyzed with a t test. Cohen’s d was used to determine the between-groups effect size at posttreatment and follow-up.

Results

Turkish adults (N=96) with depressive symptoms were randomized to the experimental group (n=49) or to a waitlist control group (n=47). High attrition rates were found among the 96 participants of which 42% (40/96) did not complete the posttest (6 weeks) and 62% (59/96) participants did not complete the follow-up assessment at 4 months. No significant difference between the experimental group and the control group was found for depression at posttest. Recovery occurred significantly more often in the experimental group (33%, 16/49) than in the control group (9%, 4/47) at posttest (P=.02). Because of the high attrition rate, a completers-only analysis was conducted at follow-up. The experimental group showed significant improvement in depression compared to the control group both at posttest (P=.01) and follow-up (P=.01).

Conclusions

The results of this study did not show a significant effect on the reduction of depressive symptoms. However, the effect size at posttest was high, which might be an indicator of the possible effectiveness of the intervention when assessed in a larger sample and robust trial. Future research should replicate our study with adequately powered samples.

Trial Registration

Dutch Trial Register: NTR2303. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2303 (Archived by WebCite at http://www.webcitation.org/6IOxNgoDu).     

Internet-Based Treatment for Adults with Depressive Symptoms: Randomized Controlled Trial

Background

Many depressed people do not receive help for their symptoms, and there are various barriers that impede help-seeking. The Internet may offer interesting alternatives for reaching and helping people with depression. Depression can be treated effectively with Internet-based cognitive behavioral therapy (CBT), but a short intervention based on problem solving therapy (PST) could constitute a worthwhile alternative to CBT.

Objective

In this study we evaluated the effectiveness of Internet-based CBT and Internet-based PST in comparison to a waiting list control group (WL), and we determined the differences between the two treatments.

Methods

We conducted a 3-arm randomized controlled trial to compare CBT, PST, and WL. The main inclusion criterion was presence of depressive symptoms (≥ 16 on the Center for Epidemiological Studies Depression scale). CBT and PST consisted of eight and five weekly lessons respectively. Participants were supported by email. Self-report measures of depression, anxiety, and quality of life were completed at pretest and after 5, 8, and 12 weeks.

Results

A total of 263 participants were randomized to the three conditions (CBT: n=88; PST: n=88; WL: n=87). Of the 263 participants, 184 (70%) completed questionnaires after 5 weeks, 173 (66%) after 8 weeks, and 151 (57%) after 12 weeks. Between-group effect sizes for depressive symptoms were 0.54 for CBT after 8 weeks (95% confidence interval (CI): 0.25 - 0.84) and 0.47 for PST after 5 weeks (95% CI: 0.17 - 0.77). These effects were further improved at 12 weeks (CBT: 0.69, 95% CI: 0.41 - 0.98; PST: 0.65, 95% CI: 0.36 - 0.95). For anxiety, effect sizes were also at a medium level. Effect sizes for quality of life were low. The number of participants showing clinically significant change at 12 weeks was significantly higher for CBT (n = 34, 38.6%) and PST (n = 30, 34.1%), compared to WL (n = 0).

Conclusions

Both Internet-based treatments are effective in reducing depressive symptoms, although the effect of PST is realized more quickly.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 16823487; http://www.controlled-trials.com/ISRCTN16823487/16823487 (Archived by WebCite at http://www.webcitation.org/5cQsOj7xf).     

Long-Term Outcomes of Internet-Based Self-Management Support in Adults With Asthma: Randomized Controlled Trial

Background

Long-term asthma management falls short of the goals set by international guidelines. The Internet is proposed as an attractive medium to support guided self-management in asthma. Recently, in a multicenter, pragmatic randomized controlled parallel trial with a follow-up period of 1 year, patients were allocated Internet-based self-management (IBSM) support (Internet group [IG]) or usual care (UC) alone. IBSM support was automatically terminated after 12 months of follow-up. In this study, IBSM support has been demonstrated to improve asthma-related quality of life, asthma control, lung function, and the number of symptom-free days as compared to UC. IBSM support was based on known key components for effective self-management and included weekly asthma control monitoring and treatment advice, online and group education, and communication (both online and offline) with a respiratory nurse.

Objective

The objective of the study was to assess the long-term effects of providing patients 1 year of IBSM support as compared to UC alone.

Methods

Two hundred adults with physician-diagnosed asthma (3 or more months of inhaled corticosteroids prescribed in the past year) from 37 general practices and 1 academic outpatient department who previously participated were invited by letter for additional follow-up at 1.5 years after finishing the study. The Asthma Control Questionnaire (ACQ) and the Asthma Quality of Life Questionnaire (AQLQ) were completed by 107 participants (60 UC participants and 47 IG participants). A minimal clinical important difference in both questionnaires is 0.5 on a 7-point scale.

Results

At 30 months after baseline, a sustained and significant difference in terms of asthma-related quality of life of 0.29 (95% CI 0.01-0.57) and asthma control of -0.33 (95% CI -0.61 to -0.05) was found in favor of the IBSM group. No such differences were found for inhaled corticosteroid dosage or for lung function, measured as forced expiratory volume in 1 second.

Conclusions

Improvements in asthma-related quality of life and asthma control were sustained in patients who received IBSM support for 1 year, even up to 1.5 years after terminating support. Future research should be focused on implementation of IBSM on a wider scale within routine asthma care.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 79864465; http://www.controlled-trials.com/ISRCTN79864465 (Archived by WebCite at http://www.webcitation.org/6J4VHhPk4).     

Internet-Based Psychodynamic versus Cognitive Behavioral Guided Self-Help for Generalized Anxiety Disorder: A Randomized Controlled Trial

Background: Guided Internet-based cognitive behavior therapy (ICBT) has been tested in many trials and found to be effective in the treatment of anxiety and mood disorders. Generalized anxiety disorder (GAD) has also been treated with ICBT, but there are no controlled trials on guided Internet-based psychodynamic treatment (IPDT). Since there is preliminary support for psychodynamic treatment for GAD, we decided to test if a psychodynamically informed self-help treatment could be delivered via the Internet. The aim of the study was to investigate the efficacy of IPDT for GAD and to compare against ICBT and a waiting list control group. Method: A randomized controlled superiority trial with individuals diagnosed with GAD comparing guided ICBT (n = 27) and IPDT (n = 27) against a no treatment waiting list control group (n = 27). The primary outcome measure was the Penn State Worry Questionnaire. Results: While there were no significant between-group differences immediately after treatment on the main outcome measure, both IPDT and ICBT resulted in improvements with moderate to large within-group effect sizes at 3 and 18 months follow-up on the primary measure in the completer analyses. The differences against the control group, although smaller, were still significant for both PDT and CBT when conforming to the criteria of clinically significant improvement. The active treatments did not differ significantly. There was a significant group by time interaction regarding GAD symptoms, but not immediately after treatment. Conclusions: IPDT and ICBT both led to modest symptom reduction in GAD, and more research is needed.     

Impact of mHealth Chronic Disease Management on Treatment Adherence and Patient Outcomes: A Systematic Review

Background

Adherence to chronic disease management is critical to achieving improved health outcomes, quality of life, and cost-effective health care. As the burden of chronic diseases continues to grow globally, so does the impact of non-adherence. Mobile technologies are increasingly being used in health care and public health practice (mHealth) for patient communication, monitoring, and education, and to facilitate adherence to chronic diseases management.

Objective

We conducted a systematic review of the literature to evaluate the effectiveness of mHealth in supporting the adherence of patients to chronic diseases management (“mAdherence”), and the usability, feasibility, and acceptability of mAdherence tools and platforms in chronic disease management among patients and health care providers.

Methods

We searched PubMed, Embase, and EBSCO databases for studies that assessed the role of mAdherence in chronic disease management of diabetes mellitus, cardiovascular disease, and chronic lung diseases from 1980 through May 2014. Outcomes of interest included effect of mHealth on patient adherence to chronic diseases management, disease-specific clinical outcomes after intervention, and the usability, feasibility, and acceptability of mAdherence tools and platforms in chronic disease management among target end-users.

Results

In all, 107 articles met all inclusion criteria. Short message service was the most commonly used mAdherence tool in 40.2% (43/107) of studies. Usability, feasibility, and acceptability or patient preferences for mAdherence interventions were assessed in 57.9% (62/107) of studies and found to be generally high. A total of 27 studies employed randomized controlled trial (RCT) methods to assess impact on adherence behaviors, and significant improvements were observed in 15 of those studies (56%). Of the 41 RCTs that measured effects on disease-specific clinical outcomes, significant improvements between groups were reported in 16 studies (39%).

Conclusions

There is potential for mHealth tools to better facilitate adherence to chronic disease management, but the evidence supporting its current effectiveness is mixed. Further research should focus on understanding and improving how mHealth tools can overcome specific barriers to adherence.     

Effectiveness of an Activity Tracker- and Internet-Based Adaptive Walking Program for Adults: A Randomized Controlled Trial

Background

The benefits of physical activity are well documented, but scalable programs to promote activity are needed. Interventions that assign tailored and dynamically adjusting goals could effect significant increases in physical activity but have not yet been implemented at scale.

Objective

Our aim was to examine the effectiveness of an open access, Internet-based walking program that assigns daily step goals tailored to each participant.

Methods

A two-arm, pragmatic randomized controlled trial compared the intervention to no treatment. Participants were recruited from a workplace setting and randomized to a no-treatment control (n=133) or to treatment (n=132). Treatment participants received a free wireless activity tracker and enrolled in the walking program, Walkadoo. Assessments were fully automated: activity tracker recorded primary outcomes (steps) without intervention by the participant or investigators. The two arms were compared on change in steps per day from baseline to follow-up (after 6 weeks of treatment) using a two-tailed independent samples t test.

Results

Participants (N=265) were 66.0% (175/265) female with an average age of 39.9 years. Over half of the participants (142/265, 53.6%) were sedentary (<5000 steps/day) and 44.9% (119/265) were low to somewhat active (5000-9999 steps/day). The intervention group significantly increased their steps by 970 steps/day over control (P<.001), with treatment effects observed in sedentary (P=.04) and low-to-somewhat active (P=.004) participants alike.

Conclusions

The program is effective in increasing daily steps. Participants benefited from the program regardless of their initial activity level. A tailored, adaptive approach using wireless activity trackers is realistically implementable and scalable.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02229409","term_id":"NCT02229409"}}NCT02229409, https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02229409","term_id":"NCT02229409"}}NCT02229409 (Archived by WebCite at http://www.webcitation.org/6eiWCvBYe)     

Impact of Seasonality on Recruitment,Retention, Adherence,and Outcomes in a Web-Based Smoking Cessation Intervention: Randomized Controlled Trial

Background

Seasonal variations in smoking and quitting behaviors have been documented, with many smokers seeking cessation assistance around the start of the New Year. What remains unknown is whether smokers who are recruited to cessation treatment trials during the New Year are as motivated to quit, or as likely to enroll in a research trial, adhere to a research protocol, and benefit from a cessation intervention compared to those who are recruited during other times of the year.

Objective

The objective of this study was to determine whether smokers recruited during the New Year period differ on measures of motivation and desire to quit, recruitment and retention rates, website utilization rates, and short-term cessation outcomes compared to smokers recruited at other times.

Methods

Participants were current smokers who had registered on a free Web-based cessation program (BecomeAnEX.org) and were invited to participate in a clinical trial. The New Year period was defined according to a clear peak and drop in the proportion of visitors who registered on the site, spanning a 15-day period from December 26, 2012 to January 9, 2013. Two other 15-day recruitment periods during summer (July 18, 2012 to August 1, 2012) and fall (November 7, 2012 to November 21, 2012) were selected for comparison. Data were examined from 3 sources: (1) a Web-based clinical trials management system that automated the recruitment and enrollment process, (2) self-report assessments at baseline and 3 months postrandomization, and (3) online tracking software that recorded website utilization during the first 3 months of the trial.

Results

Visitors to BecomeAnEX during the New Year period were more likely to register on the site than smokers who visited during summer or fall (conversion rates: 7.4%, 4.6%, 4.9%, respectively; P<.001), but there were no differences in rates of study acceptance, consent, randomization, 3-month follow-up survey completion, or cessation between the 3 periods. New Year participants were older, more educated, more likely to be employed full time, and more likely to have a relationship partner compared with participants recruited at other times during the year, but did not differ on measures of motivation and desire to quit.

Conclusions

Smokers visiting a Web-based cessation program during the New Year period were more likely to register for treatment and differ on several demographic variables, but showed similar patterns of treatment engagement, retention, follow-up, and short-term cessation outcomes compared with participants who visited the site during other periods of the year. These results allay scientific concerns about recruiting participants during this time frame and are reassuring for researchers conducting Web-based cessation trials.

Trial Registration

ClinicalTrials.gov ID: {"type":"clinical-trial","attrs":{"text":"NCT01544153","term_id":"NCT01544153"}}NCT01544153; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01544153","term_id":"NCT01544153"}}NCT01544153 (Archived by WebCite at http://www.webcitation.org/6KjhmAS9u).     

A Web-Based Adolescent Positive Psychology Program in Schools: Randomized Controlled Trial

BackgroundAdolescent mental health is characterized by relatively high rates of psychiatric disorders and low levels of help-seeking behaviors. Existing mental health programs aimed at addressing these issues in adolescents have repeated inconsistent results. Such programs have generally been based on techniques derived from cognitive behavioral therapy, which may not be ideally suited to early intervention among adolescent samples. Positive psychology, which seeks to improve well-being rather than alleviate psychological symptoms, offers an alternative approach. A previous community study of adolescents found that informal engagement in an online positive psychology program for up to 6 weeks yielded significant improvements in both well-being and depression symptoms. However, this approach had not been trialed among adolescents in a structured format and within a school setting.ObjectiveThis study examines the feasibility of an online school-based positive psychology program delivered in a structured format over a 6-week period utilizing a workbook to guide students through website content and interactive exercises.MethodsStudents from four high schools were randomly allocated by classroom to either the positive psychology condition, "Bite Back", or the control condition. The Bite Back condition consisted of positive psychology exercises and information, while the control condition used a series of non-psychology entertainment websites. Both interventions were delivered online for 6 hours over a period of 4-6 weeks during class time. Symptom measures and measures of well-being/flourishing and life satisfaction were administered at baseline and post intervention.ResultsData were analyzed using multilevel linear modeling. Both conditions demonstrated reductions in depression, stress, and total symptom scores without any significant differences between the two conditions. Both the Bite Back and control conditions also demonstrated significant improvements in life satisfaction scores post intervention. However, only the control condition demonstrated significant increases in flourishing scores post intervention.ConclusionsResults suggest that a structured online positive psychology program administered within the school curriculum was not effective when compared to the control condition. The limitations of online program delivery in school settings including logistic considerations are also relevant to the contradictory findings of this study.

Trial Registration

Australian New Zealand Clinical Trials Registry: ACTRN1261200057831; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362489 (Archived by Webcite at http://www.webcitation.org/6NXmjwfAy).     

Medium-Term Effectiveness of a Comprehensive Internet-Based and Patient-Specific Telerehabilitation Program With Text Messaging Support for Cardiac Patients: Randomized Controlled Trial

BackgroundCardiac telerehabilitation has been introduced as an adjunct or alternative to conventional center-based cardiac rehabilitation to increase its long-term effectiveness. However, before large-scale implementation and reimbursement in current health care systems is possible, well-designed studies on the effectiveness of this new additional treatment strategy are needed.ObjectiveThe aim of this trial was to assess the medium-term effectiveness of an Internet-based, comprehensive, and patient-tailored telerehabilitation program with short message service (SMS) texting support for cardiac patients.MethodsThis multicenter randomized controlled trial consisted of 140 cardiac rehabilitation patients randomized (1:1) to a 24-week telerehabilitation program in combination with conventional cardiac rehabilitation (intervention group; n=70) or to conventional cardiac rehabilitation alone (control group; n=70). In the telerehabilitation program, initiated 6 weeks after the start of ambulatory rehabilitation, patients were stimulated to increase physical activity levels. Based on registered activity data, they received semiautomatic telecoaching via email and SMS text message encouraging them to gradually achieve predefined exercise training goals. Patient-specific dietary and/or smoking cessation advice was also provided as part of the telecoaching. The primary endpoint was peak aerobic capacity (VO₂ peak). Secondary endpoints included accelerometer-recorded daily step counts, self-assessed physical activities by International Physical Activity Questionnaire (IPAQ), and health-related quality of life (HRQL) assessed by the HeartQol questionnaire at baseline and at 6 and 24 weeks.ResultsMean VO₂ peak increased significantly in intervention group patients (n=69) from baseline (mean 22.46, SD 0.78 mL/[min*kg]) to 24 weeks (mean 24.46, SD 1.00 mL/[min*kg], P<.01) versus control group patients (n=70), who did not change significantly (baseline: mean 22.72, SD 0.74 mL/[min*kg]; 24 weeks: mean 22.15, SD 0.77 mL/[min*kg], P=.09). Between-group analysis of aerobic capacity confirmed a significant difference between the intervention group and control group in favor of the intervention group (P<.001). At 24 weeks, self-reported physical activity improved more in the intervention group compared to the control group (P=.01) as did the global HRQL score (P=.01).ConclusionsThis study showed that an additional 6-month patient-specific, comprehensive telerehabilitation program can lead to a bigger improvement in both physical fitness (VO₂ peak) and associated HRQL compared to center-based cardiac rehabilitation alone. These results are supportive in view of possible future implementation in standard cardiac care.     

Web-Based Cognitive Behavioral Self-Help Intervention to Reduce Cocaine Consumption in Problematic Cocaine Users: Randomized Controlled Trial

Background

Web-based self-help programs that reduce problematic substance use are able to reach hidden consumer groups in the general population. These programs are characterized by their low treatment threshold and nonrestrictive intervention settings. They are also cost effective, making them of interest to both low-income and high-income industrialized countries with ever-increasing health costs.

Objective

To test the feasibility and effectiveness of an anonymous, fully automated, Web-based self-help intervention as an alternative to outpatient treatment services for cocaine users.

Methods

A total of 196 cocaine-using participants were recruited through various online and offline media for a randomized controlled trial. Participants in the intervention group received interactive cognitive behavioral modules and a consumption diary to reduce cocaine use, whereas participants in the control group received online psychoeducative information modules. Web-based follow-up assessments were conducted after 4 weeks, 6 weeks, and 6 months. Treatment retention was examined and compared between the intervention and control groups. Severity of cocaine dependence was the main outcome measure. Secondary outcomes were cocaine craving, depression symptoms, and alcohol and other substance use.

Results

This Web-based intervention attracted older and more educated participants than existing outpatient treatment programs for which cocaine is the primary substance of abuse. Participants in the intervention group showed greater treatment retention compared with the control group (P = .04). Low response rates at the follow-up assessments restricted the explanatory power of the analyses. At the follow-up assessments, the severity of cocaine dependence did not differ between the intervention and control groups (P = .75). Furthermore, there were no differences in cocaine craving, depression, or alcohol and other substance use. Using the consumption diaries, the average number of cocaine-free days per week did not change significantly, whereas the weekly quantity of cocaine used decreased equally in both groups (P = .009).

Conclusions

For cocaine users with low dependence severity, a fully automated Web-based cognitive behavioral self-help intervention is a feasible alternative with limited effectiveness in outpatient treatment services. However, this type of intervention may attract specific user groups that are rarely reached by existing outpatient treatment and may help them to control their cocaine consumption anonymously.

Trial Registration

ISRCTN93702927; http://www.controlled-trials.com/ISRCTN93702927 (Archived by WebCite at http://www.webcitation.org/6CTMM10MR)     

Attrition and Adherence in a Web-Based Distress Management Program for Implantable Cardioverter Defibrillator Patients (WEBCARE): Randomized Controlled Trial

Background

WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients (WEBCARE) is a Web-based randomized controlled trial, designed to improve psychological well-being in patients with an implantable cardioverter defibrillator (ICD). As in other Web-based trials, we encountered problems with attrition and adherence.

Objective

In the current study, we focus on the patient characteristics, reasons, and motivation of (1) completers, (2) those who quit the intervention, and (3) those who quit the intervention and the study in the treatment arm of WEBCARE.

Methods

Consecutive first-time ICD patients from six Dutch referral hospitals were approached for participation. After signing consent and filling in baseline measures, patients were randomized to either the WEBCARE group or the Usual Care group.

Results

The treatment arm of WEBCARE contained 146 patients. Of these 146, 34 (23.3%) completed the treatment, 88 (60.3%) dropped out of treatment but completed follow-up, and 24 (16.4%) dropped out of treatment and study. Results show no systematic differences in baseline demographic, clinical, or psychological characteristics between groups. A gradual increase in dropout was observed with 83.5% (122/146) completing the first lesson, while only 23.3% (34/146) eventually completed the whole treatment. Reasons most often given by patients for dropout were technical problems with the computer, time constraints, feeling fine, and not needing additional support.

Conclusions

Current findings underline the importance of focusing on adherence and dropout, as this remains a significant problem in behavioral Web-based trials. Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes.

Trial Registration

Clinicaltrials.gov: NCT00895700; http://www.clinicaltrials.gov/ct2/show/NCT00895700 (Archived by WebCite at http://www.webcitation.org/6NCop6Htz).     

Internet-Based Motivation Program for Women With Eating Disorders: Eating Disorder Pathology and Depressive Mood Predict Dropout

Background

One of the main problems of Internet-delivered interventions for a range of disorders is the high dropout rate, yet little is known about the factors associated with this. We recently developed and tested a Web-based 6-session program to enhance motivation to change for women with anorexia nervosa, bulimia nervosa, or related subthreshold eating pathology.

Objective

The aim of the present study was to identify predictors of dropout from this Web program.

Methods

A total of 179 women took part in the study. We used survival analyses (Cox regression) to investigate the predictive effect of eating disorder pathology (assessed by the Eating Disorders Examination-Questionnaire; EDE-Q), depressive mood (Hopkins Symptom Checklist), motivation to change (University of Rhode Island Change Assessment Scale; URICA), and participants’ age at dropout. To identify predictors, we used the least absolute shrinkage and selection operator (LASSO) method.

Results

The dropout rate was 50.8% (91/179) and was equally distributed across the 6 treatment sessions. The LASSO analysis revealed that higher scores on the Shape Concerns subscale of the EDE-Q, a higher frequency of binge eating episodes and vomiting, as well as higher depression scores significantly increased the probability of dropout. However, we did not find any effect of the URICA or age on dropout.

Conclusions

Women with more severe eating disorder pathology and depressive mood had a higher likelihood of dropping out from a Web-based motivational enhancement program. Interventions such as ours need to address the specific needs of women with more severe eating disorder pathology and depressive mood and offer them additional support to prevent them from prematurely discontinuing treatment.     

A Web-Based Health Promotion Program for Older Workers: Randomized Controlled Trial

BackgroundRecent evidence supports the efficacy of programs that promote improvements in the health practices of workers 50 years and older who are at higher risk for chronic diseases than younger workers are. Internet-based programs that promote healthy practices have also shown promise and, therefore, should be especially appropriate for workers aged 50 years and older.ObjectiveThe purpose of the research was to evaluate the effectiveness of HealthyPast50, a fully automated Web-based health promotion program based on social cognitive theory and aimed specifically at workers 50 years and older.MethodsThe randomized controlled trial was conducted across multiple US offices of a large global information technology company. The sample included 278 employees aged 50 to 68 who were recruited online and randomly assigned to the Web-based HealthyPast50 program or to a wait-list control condition. Self-report measures of diet, physical activity, stress, and tobacco use were collected online before and 3 months after the program group was given access to the program. Use data included number of log-ins and number of pages accessed. The primary analysis was multiple linear regression, following intent-to-treat principles with multiple imputation using the Markov chain Monte Carlo (MCMC) approach for nonmonotone missing data. Potential moderators from demographic characteristics and program dosage effects were assessed using multiple linear regression models. Additional analyses were conducted on complete (nonimputed) cases, excluding program participants who used the program for less than 30 minutes.ResultsRetention rates were good for both groups: 80.4% (111/138) for the program group and 94.3% (132/140) for the control group. Program group participants spent a mean of 102.26 minutes in the program (SD 148.32), logged in a mean of 4.33 times (SD 4.28), and viewed a mean of 11.04 pages (SD 20.08). In the analysis of the imputed dataset, the program group performed significantly better than the control group on diet behavioral change self-efficacy (estimated adjusted difference [Δ]=0.16, P=.048), planning healthy eating (Δ=0.17, P=.03), and mild exercise (Δ=1.03, P=.01). Moderator and dosage analyses of the dataset found no significant program effects. Analyses of the nonimputed dataset comparing program users with controls found additional significant program effects on eating practices (Δ=0.09, P=.03), exercise self-efficacy (Δ=0.12, P=.03), exercise planning (Δ=0.18, P=.03), and aging beliefs (Δ=0.17, P=.01). Moderator analysis of this dataset also found significant moderator effects of gender on multiple measures of exercise.ConclusionsA Web-based health promotion program showed promise for making a significant contribution to the short-term dietary and exercise practices of older working adults. Gender effects suggest that the program effects on exercise are due mainly to improvements among women.     

Effects Of Internet-Based Tailored Advice on the Use of Cholesterol-Lowering Interventions: A Randomized Controlled Trial

Background

Elevated low-density lipoprotein (LDL) cholesterol is a leading risk factor for cardiovascular disease. Despite the availability of proven interventions to lower LDL cholesterol, their use remains subobtimal. Many websites provide interactive, tailored advice on cardiovascular risk in an attempt to help bridge this evidence-practice gap, yet there is little evidence that provision of such a tool is effective in changing practice.

Objectives

The objective was to define the effects on use of cholesterol-lowering interventions of a consumer-targeted tailored advice website.

Methods

This was a prospective, double-blind, randomized controlled trial open to any adult Australian with access to the Internet. A total of 2099 participants were randomized. Of these, 45% were male, the mean age of all participants was 56, and 1385 (66%) self-reported hypercholesterolemia. Follow-up information was obtained for 1945 (93%). Participants completed a brief online questionnaire. Individuals assigned to intervention received immediate, fully automated, personally tailored advice (based on current guidelines) regarding the need for commencement of statin therapy, increased statin therapy in those already on treatment, and nondrug intervention strategies. Control group participants were directed to static Web pages providing general information about cholesterol management.

Results

The primary outcome was the proportion of participants that commenced or increased use of prescribed cholesterol-lowering therapy. Of the total 2099 randomized participants, 304 (14%) met eligibility criteria for cholesterol-lowering therapy but were not prescribed treatment, and 254 (12%) were prescribed treatment but were not achieving the recommended target level. Treatment was commenced or increased in 64 (6.0%) of the 1062 intervention group participants and 79 (7.6%) of the 1037 control group participants (% difference = -1.6%, 95% confidence interval [CI] -3.75 to 0.57, P = .15). No differences were found between the randomized groups for the secondary outcomes of “discussed treatment with a health professional” (% difference = -3.8%, 95% confidence interval [CI] -8.16 to 0.19, P = .08), “had their cholesterol checked” (% difference = -1.5%, 95% CI -5.79 to 2.71, P = .48), “had their blood pressure checked” (% difference = 1.4%, 95% CI -2.55 to 5.34, P = .49) or made a lifestyle change (P values between .49 and .96).

Conclusions

Despite providing specific carefully tailored advice, this website had no detectable effect on cholesterol management strategies. This finding raises considerable uncertainty about the value of Internet-based tools providing tailored advice directly to consumers.

Trial Registration

{"type":"clinical-trial","attrs":{"text":"NCT00220974","term_id":"NCT00220974"}}NCT00220974; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00220974","term_id":"NCT00220974"}}NCT00220974 (Archived by WebCite at http://www.webcitation.org/5sdq63rrY)     

Internet-Based Early Intervention to Prevent Posttraumatic Stress Disorder in Injury Patients: Randomized Controlled Trial

Background

Posttraumatic stress disorder (PTSD) develops in 10-20% of injury patients. We developed a novel, self-guided Internet-based intervention (called Trauma TIPS) based on techniques from cognitive behavioral therapy (CBT) to prevent the onset of PTSD symptoms.

Objective

To determine whether Trauma TIPS is effective in preventing the onset of PTSD symptoms in injury patients.

Methods

Adult, level 1 trauma center patients were randomly assigned to receive the fully automated Trauma TIPS Internet intervention (n=151) or to receive no early intervention (n=149). Trauma TIPS consisted of psychoeducation, in vivo exposure, and stress management techniques. Both groups were free to use care as usual (nonprotocolized talks with hospital staff). PTSD symptom severity was assessed at 1, 3, 6, and 12 months post injury with a clinical interview (Clinician-Administered PTSD Scale) by blinded trained interviewers and self-report instrument (Impact of Event Scale—Revised). Secondary outcomes were acute anxiety and arousal (assessed online), self-reported depressive and anxiety symptoms (Hospital Anxiety and Depression Scale), and mental health care utilization. Intervention usage was documented.

Results

The mean number of intervention logins was 1.7, SD 2.5, median 1, interquartile range (IQR) 1-2. Thirty-four patients in the intervention group did not log in (22.5%), 63 (41.7%) logged in once, and 54 (35.8%) logged in multiple times (mean 3.6, SD 3.5, median 3, IQR 2-4). On clinician-assessed and self-reported PTSD symptoms, both the intervention and control group showed a significant decrease over time (P<.001) without significant differences in trend. PTSD at 12 months was diagnosed in 4.7% of controls and 4.4% of intervention group patients. There were no group differences on anxiety or depressive symptoms over time. Post hoc analyses using latent growth mixture modeling showed a significant decrease in PTSD symptoms in a subgroup of patients with severe initial symptoms (n=20) (P<.001).

Conclusions

Our results do not support the efficacy of the Trauma TIPS Internet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients. Moreover, uptake was relatively low since one-fifth of individuals did not log in to the intervention. Future research should therefore focus on innovative strategies to increase intervention usage, for example, adding gameplay, embedding it in a blended care context, and targeting high-risk individuals who are more likely to benefit from the intervention.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 57754429; http://www.controlled-trials.com/ISRCTN57754429 (Archived by WebCite at http://webcitation.org/6FeJtJJyD).     

A Service-Based Evaluation of a Therapist-Supported Online Cognitive Behavioral Therapy Program for Depression

Background

Evidence suggests that Internet-delivered cognitive behavioral therapy (CBT) may be as effective as face-to-face delivery for depression, but attrition and engagement rates remain a challenge.

Objective

This service-based study aimed to evaluate an online, therapist-supported, CBT-based program for depression. The program was specifically designed to address engagement issues, most notably by integrating online therapist support and communication within the platform.

Methods

Participants were 80 adults who were registered university students. Participants used the modular online program over 8 weeks, supported by a therapist. Engagement information was gathered automatically by the online system, and analyzed for all participants. Severity of participants’ self-reported symptoms of depression were assessed preintervention and postintervention using the Beck Depression Inventory-II (BDI-II). Postintervention measures were completed by 53 participants.

Results

A high level of engagement was observed compared to a previous study within the same service, along with extensive use of a range of program features. A statistically significant (P<.001) decrease in self-reported depressive symptomatology from preintervention (mean BDI-II 25.47) to postintervention (mean BDI-II 15.53) with a large effect size (d=1.17) was also observed.

Conclusions

The results indicate the potential of unintrusive and easily provided online support to enhance engagement with online interventions. The system described in the paper also illustrates how such online support can be tightly integrated with interactive online programs by using a range of design strategies intended to improve the user experience.     

The Clinical Effectiveness of Web-Based Cognitive Behavioral Therapy With Face-to-Face Therapist Support for Depressed Primary Care Patients: Randomized Controlled Trial

Background

Most patients with mild to moderate depression receive treatment in primary care, but despite guideline recommendations, structured psychological interventions are infrequently delivered. Research supports the effectiveness of Internet-based treatment for depression; however, few trials have studied the effect of the MoodGYM program plus therapist support. The use of such interventions could improve the delivery of treatment in primary care.

Objective

To evaluate the effectiveness and acceptability of a guided Web-based intervention for mild to moderate depression, which could be suitable for implementation in general practice.

Methods

Participants (N=106) aged between 18 and 65 years were recruited from primary care and randomly allocated to a treatment condition comprising 6 weeks of therapist-assisted Web-based cognitive behavioral therapy (CBT), or to a 6-week delayed treatment condition. The intervention included the Norwegian version of the MoodGYM program, brief face-to-face support from a psychologist, and reminder emails. The primary outcome measure, depression symptoms, was measured by the Beck Depression Inventory-II (BDI-II). Secondary outcome measures included the Beck Anxiety Inventory (BAI), the Hospital Anxiety and Depression Scale (HADS), the Satisfaction with Life Scale (SWLS), and the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D). All outcomes were based on self-report and were assessed at baseline, postintervention, and at 6-month follow-up.

Results

Postintervention measures were completed by 37 (71%) and 47 (87%) of the 52 participants in the intervention and 54 participants in the delayed treatment group, respectively. Linear mixed-models analyses revealed a significant difference in time trends between the groups for the BDI-II, (P=.002), for HADS depression and anxiety subscales (P<.001 and P=.001, respectively), and for the SWLS (P<.001). No differential group effects were found for the BAI and the EQ-5D. In comparison to the control group, significantly more participants in the intervention group experienced recovery from depression as measured by the BDI-II. Of the 52 participants in the treatment program, 31 (60%) adhered to the program, and overall treatment satisfaction was high. The reduction of depression and anxiety symptoms was largely maintained at 6-month follow-up, and positive gains in life satisfaction were partly maintained.

Conclusions

The intervention combining MoodGYM and brief therapist support can be an effective treatment of depression in a sample of primary care patients. The intervention alleviates depressive symptoms and has a significant positive effect on anxiety symptoms and satisfaction with life. Moderate rates of nonadherence and predominately positive evaluations of the treatment also indicate the acceptability of the intervention. The intervention could potentially be used in a stepped-care approach, but remains to be tested in regular primary health care.

Trial Registration

Australian New Zealand Clinical Trials Registry: ACTRN12610000257066; http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12610000257066 (Archived by WebCite at http://www.webcitation.org/6Ie3YhIZa).     

Interactive Sections of an Internet-Based Intervention Increase Empowerment of Chronic Back Pain Patients: Randomized Controlled Trial

Background

Chronic back pain (CBP) represents a significant public health problem. As one of the most common causes of disability and sick leave, there is a need to develop cost-effective ways, such as Internet-based interventions, to help empower patients to manage their disease. Research has provided evidence for the effectiveness of Internet-based interventions in many fields, but it has paid little attention to the reasons why they are effective.

Objective

This study aims to assess the impact of interactive sections of an Internet-based self-management intervention on patient empowerment, their management of the disease, and, ultimately, health outcomes.

Methods

A total of 51 patients were recruited through their health care providers and randomly assigned to either an experimental group with full access to the Internet-based intervention or a control group that was denied access to the interactive sections and knew nothing thereof. The intervention took 8 weeks. A baseline, a mid-term after 4 weeks, and a final assessment after 8 weeks measured patient empowerment, physical exercise, medication misuse, and pain burden.

Results

All patients completed the study. Overall, the intervention had a moderate effect (F _1.52=2.83, P=.03, η²=0.30, d=0.55). Compared to the control group, the availability of interactive sections significantly increased patient empowerment (midterm assessment: mean difference=+1.2, P=.03, d=0.63; final assessment: mean difference=+0.8, P=.09, d=0.44) and reduced medication misuse (midterm assessment: mean difference=−1.5, P=.04, d=0.28; final assessment: mean difference=−1.6, P=.03, d=−0.55) in the intervention group. Both the frequency of physical exercise and pain burden decreased, but to equal measures in both groups.

Conclusions

Results suggest that interactive sections as part of Internet-based interventions can positively alter patients’ feelings of empowerment and help prevent medication misuse. Detrimental effects were not observed.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT02114788","term_id":"NCT02114788"}}NCT02114788; http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02114788","term_id":"NCT02114788"}}NCT02114788 (Archived by WebCite at http://www.webcitation.org/6ROXYVoPR).