Six-Month Outcomes of a Web-Based Intervention for Users of Amphetamine-Type Stimulants: Randomized Controlled Trial

Background

The use of amphetamine-type stimulants (ATS) places a large burden on health services.

Objective

The aim was to evaluate the effectiveness of a self-guided Web-based intervention (“breakingtheice”) for ATS users over 6 months via a free-to-access site.

Methods

We conducted a randomized trial comparing a waitlist control with a fully automated intervention containing 3 modules derived from cognitive behavioral therapy and motivation enhancement. The main outcome was self-reported ATS use in the past 3 months assessed at 3- and 6-month follow-ups using the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). Secondary outcomes were help-seeking intentions (general help-seeking questionnaire), actual help seeking (actual help-seeking questionnaire), psychological distress (Kessler 10), polydrug use (ASSIST), quality of life (European Health Interview Survey), days out of role, and readiness to change. Follow-up data were evaluated using an intention-to-treat (ITT) analysis with a group by time interaction.

Results

We randomized 160 people (intervention: n=81; control: n=79). At 6 months, 38 of 81 (47%) intervention and 41 of 79 (52%) control participants provided data. ATS scores significantly declined for both groups, but the interaction effect was not significant. There were significant ITT time by group interactions for actual help seeking (rate ratio [RR] 2.16; d=0.45) and help-seeking intentions (RR 1.17; d=0.32), with help seeking increasing for the intervention group and declining for the control group. There were also significant interactions for days completely (RR 0.50) and partially (RR 0.74) out of role favoring the intervention group. However, 37% (30/81) of the intervention group did not complete even 1 module.

Conclusions

This self-guided Web-based intervention encouraged help seeking associated with ATS use and reduced days out of role, but it did not reduce ATS use. Thus, this program provides a means of engaging with some sections of a difficult-to-reach group to encourage treatment, but a substantial minority remained disengaged.

Trial Registration

Australian and New Zealand Clinical Trials Registry: ACTRN12611000947909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=343307 (Archived by WebCite at http://www.webcitation.org/6Y0PGGp8q).     

Effectiveness of a Web-Based,Computer-Tailored,Pedometer-Based Physical Activity Intervention for Adults: A Cluster Randomized Controlled Trial

Background

Computer-tailored physical activity (PA) interventions delivered through the Internet represent a promising and appealing method to promote PA at a population level. However, personalized advice is mostly provided based on subjectively measured PA, which is not very accurate and might result in the delivery of advice that is not credible or effective. Therefore, an innovative computer-tailored PA advice was developed, based on objectively pedometer-measured PA.

Objective

The study aim was to evaluate the effectiveness of a computer-tailored, pedometer-based PA intervention in working adults.

Methods

Participants (≥18 years) were recruited between May and December 2012 from eight Flemish workplaces. These workplaces were allocated randomly to an intervention or control group. Intervention group participants (n=137) received (1) a booklet with information on how to increase their steps, (2) a non-blinded pedometer, and (3) an Internet link to request computer-tailored step advice. Control group participants (n=137) did not receive any of the intervention components. Self-reported and pedometer-based PA were assessed at baseline (T0), and 1 month (T1) and 3 months (T2) months post baseline. Repeated measures analyses of covariance were used to examine intervention effects for both the total sample and the at-risk sample (ie, adults not reaching 10,000 steps a day at baseline).

Results

The recruitment process resulted in 274 respondents (response rate of 15.1%) who agreed to participate, of whom 190 (69.3%) belonged to the at-risk sample. Between T0 and T1 (1-month post baseline), significant intervention effects were found for participants’ daily step counts in both the total sample (P=.004) and the at-risk sample (P=.001). In the at-risk sample, the intervention effects showed a daily step count increase of 1056 steps in the intervention group, compared to a decrease of 258 steps in the control group. Comparison of participants’ self-reported PA revealed a significant intervention effect for time spent walking in the at-risk sample (P=.02). Intervention effects were still significant 3 months post baseline for participants’ daily step counts in both the total sample (P=.03) and the at-risk sample (P=.02); however, self-reported PA differences were no longer significant.

Conclusions

A computer-tailored, pedometer-based PA intervention was effective in increasing both pedometer-based and self-reported PA levels, mainly in the at-risk participants. However, more effort should be devoted to recruit and retain participants in order to improve the public health impact of the intervention.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT02080585","term_id":"NCT02080585"}}NCT02080585; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02080585","term_id":"NCT02080585"}}NCT02080585 (Archived by WebCite at http://www.webcitation.org/6VvQnRQSy).     

Effectiveness of a Web-Based Physical Activity Intervention in Patients With Knee and/or Hip Osteoarthritis: Randomized Controlled Trial

Background

Patients with knee and/or hip osteoarthritis (OA) are less physically active than the general population, while the benefits of physical activity (PA) have been well documented. Based on the behavioral graded activity treatment, we developed a Web-based intervention to improve PA levels in patients with knee and/or hip OA, entitled “Join2move”. The Join2move intervention is a self-paced 9-week PA program in which the patient’s favorite recreational activity is gradually increased in a time-contingent way.

Objective

The aim of the study was to investigate whether a fully automated Web-based PA intervention in patients with knee and/or hip OA would result in improved levels of PA, physical function, and self-perceived effect compared with a waiting list control group.

Methods

The study design was a two-armed randomized controlled trial which was not blinded. Volunteers were recruited via articles in newspapers and health-related websites. Eligibility criteria for participants were: (1) aged 50-75 years, (2) self-reported knee and/or hip OA, (3) self-reported inactivity (30 minutes of moderate PA, 5 times or less per week), (4) no face-to-face consultation with a health care provider other than general practitioners, for OA in the last 6 months, (5) ability to access the Internet weekly, and (6) no contra-indications to exercise without supervision. Baseline, 3-month, and 12-month follow-up data were collected through online questionnaires. Primary outcomes were PA, physical function, and self-perceived effect. In a subgroup of participants, PA was measured objectively using accelerometers. Secondary outcomes were pain, fatigue, anxiety, depression, symptoms, quality of life, self-efficacy, pain coping, and locus of control.

Results

Of the 581 interested respondents, 199 eligible participants were randomly assigned to the intervention (n=100) or waiting list control group (n=99). Response rates of questionnaires were 84.4% (168/199) after 3 months and 75.4% (150/199) after 12 months. In this study, 94.0% (94/100) of participants actually started the program, and 46.0% (46/100) reached the adherence threshold of 6 out of 9 modules completed. At 3 months, participants in the intervention group reported a significantly improved physical function status (difference=6.5 points, 95% CI 1.8-11.2) and a positive self-perceived effect (OR 10.7, 95% CI 4.3-26.4) compared with the control group. No effect was found for self-reported PA. After 12 months, the intervention group showed higher levels of subjective (difference=21.2 points, 95% CI 3.6-38.9) and objective PA (difference=24 minutes, 95% CI 0.5-46.8) compared with the control group. After 12 months, no effect was found for physical function (difference=5 points, 95% CI −1.0 to 11.0) and self-perceived effect (OR 1.2, 95% CI 0.6-2.4). For several secondary endpoints, the intervention group demonstrated improvements in favor of the intervention group.

Conclusions

Join2move resulted in changes in the desired direction for several primary and secondary outcomes. Given the benefits and its self-help format, Join2move could be a component in the effort to enhance PA in sedentary patients with knee and/or hip OA.

Trial Registration

The Netherlands National Trial Register: NTR2483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2483 (Archived by WebCite at http://www.webcitation.org/67NqS6Beq).     

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).     

Efficacy of a Web-Based Computer-Tailored Smoking Prevention Intervention for Dutch Adolescents: Randomized Controlled Trial

Background

Preventing smoking initiation among adolescents is crucial to reducing tobacco-caused death and disease. This study focuses on the effectiveness of a Web-based computer-tailored smoking prevention intervention aimed at adolescents.

Objective

The intent of the study was to describe the intervention characteristics and to show the effectiveness and results of a randomized controlled trial. We hypothesized that the intervention would prevent smoking initiation among Dutch secondary school students aged 10-20 years and would have the largest smoking prevention effect among the age cohort of 14-16 years, as smoking uptake in that period is highest.

Methods

The intervention consisted of a questionnaire and fully automated computer-tailored feedback on intention to start smoking and motivational determinants. A total of 89 secondary schools were recruited via postal mail and randomized into either the computer-tailored intervention condition or the control condition. Participants had to complete a Web-based questionnaire at baseline and at 6-month follow-up. Data on smoking initiation were collected from 897 students from these schools. To identify intervention effects, multilevel logistic regression analyses were conducted using multiple imputation.

Results

Smoking initiation among students aged 10-20 years was borderline significantly lower in the experimental condition as compared to the control condition 6 months after baseline (OR 0.25, 95% CI 0.05-1.21, P=.09). Additional analyses of the data for the 14-16 year age group showed a significant effect, with 11.5% (24/209) of the students in the control condition reporting initiation compared to 5.7% (10/176) in the experimental condition (OR 0.22, 95% CI 0.05-1.02, P=.05). No moderation effects were found regarding gender and educational level.

Conclusions

The findings of this study suggest that computer-tailored smoking prevention programs are a promising way of preventing smoking initiation among adolescents for at least 6 months, in particular among the age cohort of 14-16 years. Further research is needed to focus on long-term effects.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 77864351; http://www.controlled-trials.com/ISRCTN77864351 (Archived by WebCite at http://www.webcitation.org/6BSLKSTm5).     

Short-Term Effects of a Web-Based Guided Self-Help Intervention for Employees With Depressive Symptoms: Randomized Controlled Trial

Background

Depressive disorders are highly prevalent in the working population and are associated with excessive costs. The evidence for effective worker-directed interventions for employees with depressive symptoms is limited. Treating employees with depressive symptoms before sick leave via the Internet could be beneficial and cost saving.

Objective

In this study, we developed and tested the effectiveness of a Web-based guided self-help course for employees with depressive symptoms. We report on the posttreatment effectiveness of the intervention.

Methods

This study is a two-arm randomized controlled trial comparing a Web-based guided self-help course to care as usual (CAU). We recruited employees from 6 different companies via the companies’ intranet and posters. The main inclusion criterion was elevated depressive symptoms as measured by a score of ≥16 on the Center for Epidemiological Studies Depression scale (CES-D). The intervention (Happy@Work) was based on problem-solving treatment and cognitive therapy and consisted of 6 weekly lessons. Participants were asked to submit their weekly assignment via the website after completion. They subsequently received feedback from a coach via the website. Self-report questionnaires on depressive symptoms (CES-D; primary outcome), anxiety measured by the Hospital Anxiety and Depression Scale (HADS), burnout measured by the Maslach Burnout Inventory (MBI), and work performance measured by the Health and Work Performance Questionnaire (HPQ; secondary outcomes) were completed at baseline and at posttreatment.

Results

A total of 231 employees were randomized to either the intervention group (n=116) or CAU (n=115).The posttreatment assessment was completed by 171 (74.0%) participants. Both the intervention and the CAU group showed significant improvements in the primary outcome of depressive symptoms, but no differences between the conditions was found (d=0.16, 95% CI –0.10 to 0.41, P=.29). Significant but small effects in favor of the intervention group were found for anxiety symptoms (d=0.16, 95% CI –0.09 to 0.42, P=.04) and exhaustion (d=0.17, 95% CI –0.09 to 0.43, P=.02).

Conclusions

This study showed that a Web-based guided self-help course for employees with depressive symptoms was not more effective in reducing depressive symptoms among employees than CAU. Large improvements in depressive symptoms in the CAU group were unforeseen and potential explanations are discussed.     

Effects of a Guided Web-Based Smoking Cessation Program With Telephone Counseling: A Cluster Randomized Controlled Trial

Background

Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners.

Objective

Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting.

Methods

The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks.

Results

We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95% CI -4.7 to 0.3; P=.080).

Conclusions

This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care. The limited statistical power and the high drop-out rate may have reduced the study’s ability to detect significant differences between the groups. Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome.

Trial Registration

German Register for Clinical Trials, registration number DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6Sff1YZpx).     

Chinese My Trauma Recovery,A Web-Based Intervention for Traumatized Persons in Two Parallel Samples: Randomized Controlled Trial

Background

Guided self-help interventions for PTSD (post-traumatic stress disorder) are a promising tool for the dissemination of contemporary psychological treatment.

Objective

This study investigated the efficacy of the Chinese version of the My Trauma Recovery (CMTR) website.

Methods

In an urban context, 90 survivors of different trauma types were recruited via Internet advertisements and allocated to a randomized controlled trial (RCT) with a waiting list control condition. In addition, in a rural context, 93 survivors mainly of the 2008 Sichuan earthquake were recruited in-person for a parallel RCT in which the website intervention was conducted in a counseling center and guided by volunteers. Assessment was completed online on a professional Chinese survey website. The primary outcome measure was the Post-traumatic Diagnostic Scale (PDS); secondary outcome measures were Symptom Checklist 90-Depression (SCL-D), Trauma Coping Self-Efficacy Scale (CSE), Post-traumatic Cognitive Changes (PCC), and Social Functioning Impairment (SFI) questionnaires adopted from the My Trauma Recovery website.

Results

For the urban sample, findings indicated a significant group×time interaction in post-traumatic symptom severity (F _1,88=7.65, P=.007). CMTR reduced post-traumatic symptoms significantly with high effect size after one month of treatment (F _1,45=15.13, Cohen’s d=0.81, P<.001) and the reduction was sustained over a 3-month follow-up (F _1,45=17.29, Cohen’s d=0.87, P<.001). In the rural sample, the group×time interaction was also significant in post-traumatic symptom severity (F _1,91=5.35, P=.02). Post-traumatic symptoms decreased significantly after treatment (F _1,48=43.97, Cohen’s d=1.34, P<.001) and during the follow-up period (F _1,48=24.22, Cohen’s d=0.99, P<.001). Additional outcome measures (post-traumatic cognitive changes, depression) indicated a range of positive effects, in particular in the urban sample (group×time interactions: F _1,88=5.32-8.37, all Ps<.03), contributing to the positive evidence for self-help interventions. Differences in the effects in the two RCTs are exploratorily explained by sociodemographic, motivational, and setting feature differences between the two samples.

Conclusions

These findings give support for the short-term efficacy of CMTR in the two Chinese populations and contribute to the literature that self-help Web-based programs can be used to provide mental health help for traumatized persons.

Trial Registration

Australia New Zealand Clinical Trials Registry (ANZCTR): ACTRN12611000951954; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000951954 (Archived by WebCite at http://www.webcitation.org/6G7WyNODk).     

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).     

Two Fully Automated Web-Based Interventions for Risky Alcohol Use: Randomized Controlled Trial

Background

Excessive alcohol use is a widespread problem in many countries, especially among young people. To reach more people engaging in high-risk drinking behaviors, a number of online programs have been developed in recent years. Change Your Drinking is a German, diary-based, fully automated alcohol intervention. In 2010, a revised version of the program was developed. It is more strongly oriented to concepts of relapse prevention than the previous version, includes more feedback, and offers more possibilities to interact with the program. Moreover, the program duration was extended from 10 to 14 days.

Objective

This paper examines whether the revised version of Change Your Drinking is more effective in reducing alcohol consumption than the original version.

Methods

The effectiveness of both program versions was compared in a Web-based, open, randomized controlled trial with follow-up surveys 6 weeks and 3 months after registration. Participants were recruited online and were randomly assigned to either the original or the revised version of Change Your Drinking. The following self-assessed outcomes were used: alcohol use days, alcohol intake in grams, the occurrence of binge drinking and risky drinking (all referring to the past 7 days prior to each survey), and the number of alcohol-related problems.

Results

A total of 595 participants were included in the trial. Follow-up rates were 58.0% after 6 weeks and 49.6% after 3 months. No significant group differences were found in any of the outcomes. However, the revised version was used by more participants (80.7%) than the original version (55.7%). A significant time effect was detected in all outcomes (alcohol use days: P=.002; alcohol intake in grams: P<.001; binge drinking: P<.001; alcohol-related problems: P=.004; risky drinking: P<.001).

Conclusions

The duration and complexity of the program played a minor role in reducing alcohol consumption. However, differences in program usage between the versions suggest the revised version was more attractive to participants.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 31586428; http://www.controlled-trials.com/ISRCTN31586428/ (Archived by WebCite at http://www.webcitation.org/6BFxApCUT)     

Effects of a Web-Based Intervention for Stress Reduction in Primary Care: A Cluster Randomized Controlled Trial

Background

Preliminary findings suggest that Web-based interventions may be effective in achieving significant stress reduction. To date, there are no findings available for primary care patients. This is the first study that investigates a Web-based intervention for stress reduction in primary care.

Objective

The aim was to examine the short-term effectiveness of a fully automated Web-based coaching program regarding stress reduction in a primary care setting.

Methods

The study was an unblinded cluster randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily text message reminders, and weekly feedback through the Internet. All components of the program were fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was change in the Perceived Stress Questionnaire (PSQ) over 12 weeks.

Results

A total of 93 participants (40 in intervention group, 53 in control group) were recruited into the study. For 25 participants from the intervention group and 49 participants from the control group, PSQ scores at baseline and 12 weeks were available. In the intention-to-treat analysis, the PSQ score decreased by mean 8.2 (SD 12.7) in the intervention group and by mean 12.6 (SD 14.7) in the control group. There was no significant difference identified between the groups (mean difference –4.5, 95% CI –10.2 to 1.3, P=.13).

Conclusions

This trial could not show that the tested Web-based intervention was effective for reducing stress compared to usual care. The limited statistical power and the high dropout rate may have reduced the study’s ability to detect significant differences between the groups. Further randomized controlled trials are needed with larger populations to investigate the long-term outcome as well as the contents of usual primary care.

Trial Registration

German Clinical Trials Register DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6eXk0PXmO)     

Reducing Suicidal Ideation: Cost-Effectiveness Analysis of a Randomized Controlled Trial of Unguided Web-Based Self-help

Background

Suicidal ideation is highly prevalent, but often remains untreated. The Internet can be used to provide accessible interventions.

Objective

To evaluate the cost-effectiveness of an online, unguided, self-help intervention for reducing suicidal ideation.

Methods

A total of 236 adults with mild to moderate suicidal thoughts, defined as scores between 1-26 on the Beck Scale for Suicide Ideation (BSS), were recruited in the general population and randomized to the intervention (n = 116) or to a waitlist, information-only, control group (n = 120). The intervention aimed to decrease the frequency and intensity of suicidal ideation and consisted of 6 modules based on cognitive behavioral techniques. Participants in both groups had unrestricted access to care as usual. Assessments took place at baseline and 6 weeks later (post-test). All questionnaires were self-report and administered via the Internet. Treatment response was defined as a clinically significant decrease in suicidal ideation on the BSS. Total per-participant costs encompassed costs of health service uptake, participants’ out-of-pocket expenses, costs stemming from production losses, and intervention costs. These were expressed in Euros (€) for the reference year 2009.

Results

At post-test, treatment response was 35.3% and 20.8% in the experimental and control conditions, respectively. The incremental effectiveness was 0.35 − 0.21 = 0.15 (SE 0.06, P = .01). The annualized incremental costs were −€5039 per participant. Therefore, the mean incremental cost-effectiveness ratio (ICER) was estimated to be −€5039/0.15 = −€34,727 after rounding (US −$41,325) for an additional treatment response, indicating annual cost savings per treatment responder.

Conclusions

This is the first trial to indicate that online self-help to reduce suicidal ideation is feasible, effective, and cost saving. Limitations included reliance on self-report and a short timeframe (6 weeks). Therefore, replication with a longer follow-up period is recommended.     

Effectiveness of a Web-Based Solution-Focused Brief Chat Treatment for Depressed Adolescents and Young Adults: Randomized Controlled Trial

Background

Up to 9% of young people suffer from depression. Unfortunately, many in need of help remain untreated. The Internet offers anonymous ways to help depressed youth, especially those who are reluctant to search for help because of fear of stigma.

Objective

Our goal was to evaluate the effectiveness of an individual chat treatment based on Solution-Focused Brief Therapy (SFBT) to young individuals aged 12-22 years with depressive symptoms by comparing it to a waiting list control group.

Methods

For this study, 263 young people with depressive symptoms were randomized to the Web-based SFBT intervention, PratenOnline, or to a waiting list control condition. The chat treatment was delivered by trained professionals. Groups were compared on depressive complaints as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) after 9 weeks and 4.5 months. For the chat group only, changes in depressive symptoms at 7.5 months after baseline were explored.

Results

The experimental SFBT condition (n=131) showed significantly greater improvement than the waiting list condition (n=132) in depressive symptoms at 9 weeks and 4.5 months on the CES-D, with a small between group effect size at 9 weeks (d=0.18, 95% CI -0.10 to 0.47) and a large effect size at 4.5 months (d=0.79, 95% CI 0.45-1.08). The percentage of participants showing a reliable and clinically significant change in depression was significantly larger for the SFBT intervention at 4.5 months only (28.2% vs 11.4% for the waiting list, P<.001, number needed to treat=6). At 7.5 months, the SFBT group showed further improvements. However, results have to be considered carefully because of high attrition rates.

Conclusions

The Web-based SFBT chat intervention of PratenOnline was more effective than a waiting list control group in reducing depressive symptoms, and effects were larger at follow-up then at post-treatment. More studies are needed to find out if outcomes will be replicated, especially for those younger than 18 year old.

Trial Registration

Netherlands Trial Register: NTR 1696; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1696 (Archived by WebCite at http://www.webcitation.org/6DspeYWrJ).     

Effectiveness of Web-Based Self-Disclosure Peer-to-Peer Support for Weight Loss: Randomized Controlled Trial

Background

Obesity is one of the most common public health problems in the industrialized world as a cause of noncommunicable diseases. Although primarily used for one-on-one communication, email is available for uninterrupted support for weight loss, but little is known about the effects of dietitian group counseling for weight control via the Internet.

Objective

We developed a Web-based self-disclosure health support (WSHS) system for weight loss. This study aims to compare the effect of weight change between those using the WSHS and those using the email health support (EHS).

Methods

This study was designed as an open prospective individual randomized controlled trial. Eligible participants were aged 35 to 65 years with a body mass index (BMI) of ≥25.0 in their latest health examination. Participants were randomly assigned to either the WSHS group or the EHS group. Thirteen registered dietitians under the direction of a principal dietitian each instructed 6 to 8 participants from the respective groups. All participants in the WSHS group could receive nutritional advice and calculate their nutritive intake from a photograph of a meal on their computer screen from the Internet sent to them by their dietitian, receive supervision from the registered dietitian, and view fellow participants’ weight changes and lifestyle modifications. In the EHS group, a participant could receive one-on-one nutritional advice and calculate his/her nutritive intake from the photograph of a meal on computer screen sent by email from his/her dietitian, without being able to view fellow participants’ status. The follow-up period was 12 weeks for both groups. The primary outcome measure was change in body weight. The secondary outcome measure included changes in BMI and waist circumference. The intergroup comparison of the changes before and after intervention was evaluated using analysis of covariance.

Results

A total of 193 participants were randomly assigned to either the WSHS group (n=97) or the EHS group (n=96). Ten from the WSHS group and 8 from the EHS group dropped out during the study period, and the remaining 87 in the WSHS group and 88 in the EHS group were followed up completely. Weight loss was significantly greater in the WSHS group than in the EHS group (–1.6 kg vs –0.7 kg; adjusted P=.04). However, there were few differences in waist circumference between the 2 groups. (–3.3 cm vs –3.0 cm; adjusted P=.71).

Conclusions

Our newly developed WSHS system using forced self-disclosure had better short-term weight loss results. Further study in a longer-term trial is necessary to determine what effects this type of intervention might have on long-term cardiovascular disease.

Trial Registration

University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR): UMIN000009147; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000010719&language=E (Archived by WebCite at http://www.webcitation.org/6HTCkhb1p).     

Web-Based Cognitive Behavioral Therapy for Female Patients With Eating Disorders: Randomized Controlled Trial

Background

Many patients with eating disorders do not receive help for their symptoms, even though these disorders have severe morbidity. The Internet may offer alternative low-threshold treatment interventions.

Objective

This study evaluated the effects of a Web-based cognitive behavioral therapy (CBT) intervention using intensive asynchronous therapeutic support to improve eating disorder psychopathology, and to reduce body dissatisfaction and related health problems among patients with eating disorders.

Methods

A two-arm open randomized controlled trial comparing a Web-based CBT intervention to a waiting list control condition (WL) was carried out among female patients with bulimia nervosa (BN), binge eating disorder (BED), and eating disorders not otherwise specified (EDNOS). The eating disorder diagnosis was in accordance with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, and was established based on participants’ self-report. Participants were recruited from an open-access website, and the intervention consisted of a structured two-part program within a secure Web-based application. The aim of the first part was to analyze participant’s eating attitudes and behaviors, while the second part focused on behavioral change. Participants had asynchronous contact with a personal therapist twice a week, solely via the Internet. Self-report measures of eating disorder psychopathology (primary outcome), body dissatisfaction, physical health, mental health, self-esteem, quality of life, and social functioning were completed at baseline and posttest.

Results

A total of 214 participants were randomized to either the Web-based CBT group (n=108) or to the WL group (n=106) stratified by type of eating disorder (BN: n=44; BED: n=85; EDNOS: n=85). Study attrition was low with 94% of the participants completing the posttest assignment. Overall, Web-based CBT showed a significant improvement over time for eating disorder psychopathology (F ₉₇=63.07, P<.001, d=.82) and all secondary outcome measures (effect sizes between d=.34 to d=.49), except for Body Mass Index. WL participants also improved on most outcomes; however, effects were smaller in this group with significant between-group effects for eating disorder psychopathology (F ₂₀₁=9.42, P=.002, d=.44), body dissatisfaction (F ₂₀₁=13.16, P<.001, d=.42), physical health (F ₂₀₀=12.55, P<.001, d=.28), mental health (F ₂₀₃=4.88, P=.028, d=.24), self-esteem (F ₂₀₂=5.06, P=.026, d=.20), and social functioning (F ₂₀₅=7.93, P=.005, d=.29). Analyses for the individual subgroups BN, BED, and EDNOS showed that eating disorder psychopathology improved significantly over time among Web-based CBT participants in all three subgroups; however, the between-group effect was significant only for participants with BED (F ₇₈=4.25, P=.043, d=.61).

Conclusions

Web-based CBT proved to be effective in improving eating disorder psychopathology and related health among female patients with eating disorders.

Trial Registration

Nederlands Trial Register (NTR): NTR2415; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2415 (Archived by WebCite at http://www.webcitation.org/6T2io3DnJ).     

Long-Term Results of a Web-Based Guided Self-Help Intervention for Employees With Depressive Symptoms: Randomized Controlled Trial

Background

Depressive disorders are highly prevalent in the working population and are associated with excessive costs. The evidence for effective worker-directed interventions for employees with depressive symptoms is limited. Treating employees with depressive symptoms via the Internet before they report sick from work could be beneficial and cost saving.

Objective

In this study, we tested the effectiveness over the period of 1 year of a Web-based guided self-help intervention, called Happy@Work, for employees with depressive symptoms who were not on sick leave.

Methods

A two-arm randomized controlled trial comparing a worker-directed, Web-based, guided self-help intervention to care as usual (CAU) was carried out. We recruited employees from 6 companies via the company’s Intranet and by putting up posters. The inclusion criteria were elevated depressive symptoms as measured by a score ≥16 on the Center for Epidemiologic Studies Depression scale (CES-D) and not being on sick leave. The intervention contained 6 lessons and consisted of problem-solving treatment and cognitive therapy. Participants were asked to submit weekly assignments via the website after completion of a lesson and they received feedback from a coach via the website. Self-report questionnaires on depressive symptoms (CES-D; primary outcome), burnout (Maslach Burnout Inventory, MBI), work performance (Health and Work Performance Questionnaire, HPQ), duration of absenteeism, and anxiety (Hospital Anxiety and Depression Scale, HADS; secondary outcomes), were completed at baseline, posttreatment, and at 6-, and 12-month follow-up. Several subgroup and per-protocol analyses were performed.

Results

A total of 231 employees were randomized to either the intervention group (n=116) or to CAU (n=115). Completion of assessments varied between 54%-74%. Improvement in depressive symptoms between baseline and posttreatment was shown in all participants and these effects sustained over time. However, there were no differences between the 2 groups (adjusted regression coefficient=0.46, 95% CI –2.11 to 3.03, P=.72; Cohen’s d=0.05). Differences between groups were also not significant for the secondary outcomes. No subgroups were identified to show differences between the groups, nor did we find a between-group effect in the per-protocol analyses.

Conclusions

This study showed that a worker-directed, Web-based, guided self-help intervention was not more effective than CAU in reducing depressive symptoms among employees with depressive symptoms who were not on sick leave over the period of 1 year. An intervention for this specific target group might not be necessary because the recovery in the CAU group was comparable to the intervention group and sustained over a 12-month period.

Trial Registration

Nederlands Trial Register (NTR): NTR2993; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2993 (Archived by WebCite at http://www.webcitation.org/6PL9pFC0n).     

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).     

Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial

BackgroundWork-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting.ObjectiveThis randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees.MethodsA total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus’s transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only.ResultsAn intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F _1,261=58.08, P<.001; Cohen’s d=0.83) and at the 6-month follow-up (F _1,261=80.17, P<.001; Cohen’s d=1.02). The effects in the iSMI group were maintained at 12-month follow-up.ConclusionsThis Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions.

Trial Registration

German Clinical Trials Register (DRKS): 00004749; http://drks-neu.uniklinik-freiburg.de/ drks_web/setLocale_EN.do (Archived by WebCite at http://www.webcitation.org/6e8rl98nl)     

Economic Evaluation of a Web-Based Tailored Lifestyle Intervention for Adults: Findings Regarding Cost-Effectiveness and Cost-Utility From a Randomized Controlled Trial

Background

Different studies have reported the effectiveness of Web-based computer-tailored lifestyle interventions, but economic evaluations of these interventions are scarce.

Objective

The objective was to assess the cost-effectiveness and cost-utility of a sequential and a simultaneous Web-based computer-tailored lifestyle intervention for adults compared to a control group.

Methods

The economic evaluation, conducted from a societal perspective, was part of a 2-year randomized controlled trial including 3 study groups. All groups received personalized health risk appraisals based on the guidelines for physical activity, fruit intake, vegetable intake, alcohol consumption, and smoking. Additionally, respondents in the sequential condition received personal advice about one lifestyle behavior in the first year and a second behavior in the second year; respondents in the simultaneous condition received personal advice about all unhealthy behaviors in both years. During a period of 24 months, health care use, medication use, absenteeism from work, and quality of life (EQ-5D-3L) were assessed every 3 months using Web-based questionnaires. Demographics were assessed at baseline, and lifestyle behaviors were assessed at both baseline and after 24 months. Cost-effectiveness and cost-utility analyses were performed based on the outcome measures lifestyle factor (the number of guidelines respondents adhered to) and quality of life, respectively. We accounted for uncertainty by using bootstrapping techniques and sensitivity analyses.

Results

A total of 1733 respondents were included in the analyses. From a willingness to pay of €4594 per additional guideline met, the sequential intervention (n=552) was likely to be the most cost-effective, whereas from a willingness to pay of €10,850, the simultaneous intervention (n=517) was likely to be most cost-effective. The control condition (n=664) appeared to be preferred with regard to quality of life.

Conclusions

Both the sequential and the simultaneous lifestyle interventions were likely to be cost-effective when it concerned the lifestyle factor, whereas the control condition was when it concerned quality of life. However, there is no accepted cutoff point for the willingness to pay per gain in lifestyle behaviors, making it impossible to draw firm conclusions. Further economic evaluations of lifestyle interventions are needed.

Trial Registration

Dutch Trial Register NTR2168; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2168 (Archived by WebCite at http://www.webcitation.org/6MbUqttYB).