Internet Cognitive Behavioral Therapy for Women With Postnatal Depression: A Randomized Controlled Trial of MumMoodBooster

BackgroundThere are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and none that assess diagnostic status (clinical remission) as the primary outcome. This is despite the need to improve treatment uptake and accessibility because fewer than 50% of postnatally depressed women seek help, even when identified as depressed.ObjectiveIn a randomized controlled trial (RCT), we aimed to test the efficacy of a 6-session Internet intervention (the MumMoodBooster program, previously evaluated in a feasibility trial) in a sample of postnatal women with a clinical diagnosis of depression. The MumMoodBooster program is a cognitive behavioral therapy (CBT) intervention, is highly interactive, includes a partner website, and was supported by low-intensity telephone coaching.MethodsThis was a parallel 2-group RCT (N=43) comparing the Internet CBT treatment (n=21) to treatment as usual (n=22). At baseline and at 12 weeks after enrollment, women’s diagnostic status was assessed by telephone with the Standardized Clinical Interview for DSM-IV (SCID-IV) and symptom severity with the Beck Depression Inventory (BDI-II). Depression symptoms were measured repeatedly throughout the study period with the Patient Health Questionnaire (PHQ-9).ResultsAt the end of the study, 79% (15/19) of women who received the Internet CBT treatment no longer met diagnostic criteria for depression on the SCID-IV (these outcome data were missing for 2 intervention participants). This contrasted with only 18% (4/22) remission in the treatment as usual condition. Depression scores on the BDI-II showed a large effect favoring the intervention group (d=.83, 95% CI 0.20-1.45). Small to medium effects were found on the PHQ-9 and on measures of anxiety and stress. Adherence to the program was very good with 86% (18/21) of users completing all sessions; satisfaction with the program was rated 3.1 out of 4 on average.ConclusionsOur results suggest that our Internet CBT program, MumMoodBooster, is an effective treatment option for women clinically diagnosed with PND. This is one of only two controlled evaluations of specialized online psychological treatment among women clinically diagnosed with PND. MumMoodBooster appears to be a feasible, effective treatment option, which is potentially accessible to large numbers of women in metropolitan, rural, and remote areas. Future work might be focused profitably on establishing comparability with face-to-face treatments and purely self-guided delivery. We have commenced a larger RCT comparing MumMoodBooster with face-to-face CBT.

Trial Registration

Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363561 (Archived by WebCite® at http://www.webcitation.org/6f64kuyLf).     

The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial

BackgroundDepressive symptoms, and the associated coexistence of symptoms of anxiety and decreased quality of life (QoL), are common in patients with heart failure (HF). However, treatment strategies for depressive symptoms in patients with HF still remain to be established. Internet-based cognitive behavioral therapy (ICBT), as guided self-help CBT programs, has shown good effects in the treatment of depression. Until now, ICBT has not been evaluated in patients with HF with depressive symptoms.ObjectiveThe aims of this study were to (1) evaluate the effect of a 9-week guided ICBT program on depressive symptoms in patients with HF; (2) investigate the effect of the ICBT program on cardiac anxiety and QoL; and (3) assess factors associated with the change in depressive symptoms.MethodsFifty participants were randomized into 2 treatment arms: ICBT or a Web-based moderated discussion forum (DF). The Patient Health Questionnaire-9 was used to measure depressive symptoms, the Cardiac Anxiety Questionnaire (CAQ) was used to measure cardiac-related anxiety, and the Minnesota Living with Heart Failure questionnaire was used to measure QoL. Data were collected at baseline and at follow-up at the end of the 9-week intervention. Intention-to-treat analysis was used, and missing data were imputed by the Expectation-Maximization method. Between-group differences were determined by analysis of covariance with control for baseline score and regression to the mean.ResultsNo significant difference in depressive symptoms between the ICBT and the DF group at the follow-up was found, [F(1,47)=1.63, P=.21] and Cohen´s d=0.26. Secondary within-group analysis of depressive symptoms showed that such symptoms decreased significantly in the ICBT group from baseline to the follow-up (baseline M=10.8, standard deviation [SD]=5.7 vs follow-up M=8.6, SD=4.6, t(24)=2.6, P=.02, Cohen´s d=0.43), whereas in the DF group, there was no significant change (baseline M=10.6, SD=5.0, vs follow-up M=9.8, SD=4.3, t(24)=0.93, P=.36. Cohen´s d=0.18). With regard to CAQ and QoL no significant differences were found between the groups (CAQ [d(1,47)=0.5, P=.48] and QoL [F(1,47)=2.87, P=.09]). In the ICBT group in the CAQ subscale of fear, a significant within-group decrease was shown (baseline M=1.55 vs follow-up M=1.35, P=.04). In the ICBT group, the number of logins to the Web portal correlated significantly with improvement in depressive symptoms (P=.02), whereas higher age (P=.01) and male sex (P=.048) were associated with less change in depressive symptoms. This study is underpowered because of difficulties in the recruitment of patients.ConclusionsGuided ICBT adapted for persons with HF and depressive symptoms was not statistically superior to participation in a Web-based DF. However, within the ICBT group, a statically significant improvement of depressive symptoms was detected.ClinicalTrialClinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01681771","term_id":"NCT01681771"}}NCT01681771; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01681771","term_id":"NCT01681771"}}NCT01681771 (Archived by WebCite at http://www.webcitation.org/6ikzbcuLN)     

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).     

Comparing In-Person to Videoconference-Based Cognitive Behavioral Therapy for Mood and Anxiety Disorders: Randomized Controlled Trial

Background

Cognitive-behavioral therapy (CBT) has demonstrated efficacy and effectiveness for treating mood and anxiety disorders. Dissemination of CBT via videoconference may help improve access to treatment.

Objective

The present study aimed to compare the effectiveness of CBT administered via videoconference to in-person therapy for a mixed diagnostic cohort.

Methods

A total of 26 primarily Caucasian clients (mean age 30 years, SD 11) who had a primary Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV-TR) diagnosis of a mood or anxiety disorder were randomly assigned to receive 12 sessions of CBT either in-person or via videoconference. Treatment involved individualized CBT formulations specific to the presenting diagnosis; all sessions were provided by the same therapist. Participants were recruited through a university clinic. Symptoms of depression, anxiety, stress, and quality of life were assessed using questionnaires before, after, and 6 weeks following treatment. Secondary outcomes at posttreatment included working alliance and client satisfaction.

Results

Retention was similar across treatment conditions; there was one more client in the videoconferencing condition at posttreatment and at follow-up. Statistical analysis using multilevel mixed effects linear regression indicated a significant reduction in client symptoms across time for symptoms of depression (P<.001, d=1.41), anxiety (P<.001, d=1.14), stress (P<.001, d=1.81), and quality of life (P<.001, d=1.17). There were no significant differences between treatment conditions regarding symptoms of depression (P=.165, d=0.37), anxiety (P=.41, d=0.22), stress (P=.15, d=0.38), or quality of life (P=.62, d=0.13). There were no significant differences in client rating of the working alliance (P=.53, one-tailed, d=–0.26), therapist ratings of the working alliance (P=.60, one-tailed, d=0.23), or client ratings of satisfaction (P=.77, one-tailed, d=–0.12). Fisher’s Exact P was not significant regarding differences in reliable change from pre- to posttreatment or from pretreatment to follow-up for symptoms of depression (P=.41, P=.26), anxiety (P=.60, P=.99), or quality of life (P=.65, P=.99) but was significant for symptoms of stress in favor of the videoconferencing condition (P=.03, P=.035). Difference between conditions regarding clinically significant change was also not observed from pre- to posttreatment or from pretreatment to follow-up for symptoms of depression (P=.67, P=.30), anxiety (P=.99, P=.99), stress (P=.19, P=.13), or quality of life (P=.99, P=.62).

Conclusions

The findings of this controlled trial indicate that CBT was effective in significantly reducing symptoms of depression, anxiety, and stress and increasing quality of life in both in-person and videoconferencing conditions, with no significant differences being observed between the two.

Trial Registration

Australian New Zealand Clinical Trials Registry ID: ACTRN12609000819224; http://www.anzctr.org.au/ACTRN12609000819224.aspx (Archived by WebCite at http://www.webcitation.org/6Kz5iBMiV).     

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.     

Short-Term Effectiveness of Web-Based Guided Self-Help for Phobic Outpatients: Randomized Controlled Trial

Background

Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias.

Objective

The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance.

Methods

We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed.

Results

At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks.

Conclusions

Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in routine outpatient practice.

Trial Registration

Netherlands Trial Register NTR2233; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2233 (Archived by WebCite at http://www.webcitation.org/6O2ioOQSs).     

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 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).     

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).     

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).     

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)     

Cognitive Behavioral Therapy and Acceptance and Commitment Therapy for the Anxiety Disorders: Two Approaches With Much to Offer

Arch and Craske (2008 ) examine the similarities and differences between cognitive behavioral therapy and acceptance and commitment therapy for the anxiety disorders and suggest that the two treatment approaches have as many similarities as differences. We agree and believe that there is merit in this conclusion—it brings us together in common purpose and helps move us toward improved approaches to reducing client suffering. Our discussion focuses on the similarities that we think about most positively and the differences of which we should be mindful.     

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.     

Allegiance Bias and Therapist Effects: Results of a Randomized Controlled Trial of Binge Eating Disorder

[Clin Psychol Sci Prac 18: 119–125, 2011] “Allegiance bias” has been hypothesized to compromise the findings of randomized controlled trials (RCTs). In contrast, our multisite RCT involving the collaboration of investigators with different allegiances regarding interpersonal psychotherapy (IPT), guided self‐help cognitive behavior therapy (CBTgsh), and behavioral weight loss therapy (BWL) for binge eating disorder showed no evidence of any differential site × treatment effects. The findings indicate that “allegiance bias” does not necessarily occur in well‐controlled RCTs with appropriate therapist training. We also examined the role of individual therapist differences that have been alleged to be more important than treatment effects. No individual therapist effects emerged on any measure in either IPT or CBTgsh, both of which were significantly more effective than BWL at two‐year follow‐up.     

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).     

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).     

Comparing Effects in Regular Practice of E-Communication and Web-Based Self-Management Support Among Breast Cancer Patients: Preliminary Results From a Randomized Controlled Trial

BackgroundWhile Web-based interventions have been shown to assist a wide range of patients successfully in managing their illness, few studies have examined the relative contribution of different Web-based components to improve outcomes. Further efficacy trials are needed to test the effects of Web support when offered as a part of routine care.ObjectiveOur aim was to compare in regular care the effects of (1) an Internet-based patient provider communication service (IPPC), (2) WebChoice, a Web-based illness management system for breast cancer patients (IPPC included), and (3) usual care on symptom distress, anxiety, depression, (primary outcomes), and self-efficacy (secondary outcome). This study reports preliminary findings from 6 months’ follow-up data in a 12-month trial.MethodsWe recruited 167 patients recently diagnosed with breast cancer and undergoing treatment from three Norwegian hospitals. The nurse-administered IPPC allowed patients to send secure e-messages to and receive e-messages from health care personnel at the hospital where they were treated. In addition to the IPPC, WebChoice contains components for symptom monitoring, tailored information and self-management support, a diary, and communication with other patients. A total of 20 care providers (11 nurses, 6 physicians, and 3 social workers) were trained to answer questions from patients. Outcomes were measured with questionnaires at study entry and at study months 2, 4, and 6. Linear mixed models for repeated measures were fitted to compare effects on outcomes over time.ResultsPatients were randomly assigned to the WebChoice group (n=64), the IPPC group (n=45), or the usual care group (n=58). Response rates to questionnaires were 73.7% (123/167) at 2 months, 65.9 (110/167) at 4 months, and 62.3% (104/167) at 6 months. Attrition was similar in all study groups. Among those with access to WebChoice, 64% (41/64) logged on more than once and 39% (25/64) sent e-messages to care providers. In the IPPC group, 40% (18/45) sent e-messages. Linear mixed models analyses revealed that the WebChoice group reported significantly lower symptom distress (mean difference 0.16, 95% CI 0.06-0.25, P=.001), anxiety (mean difference 0.79, 95% CI 0.09-1.49, P=.03), and depression (mean difference 0.79, 95% CI 0.09-1.49, P=.03) compared with the usual care group. The IPPC group reported significant lower depression scores compared with the usual care group (mean difference 0.69, 95% CI 0.05-1.32, P=.03), but no differences were observed for symptom distress or anxiety. No significant differences in self-efficacy were found among the study groups.ConclusionsIn spite of practice variations and moderate use of the interventions, our results suggest that offering Web support as part of regular care can be a powerful tool to help patients manage their illness. Our finding that a nurse-administered IPPC alone can significantly reduce depression is particularly promising. However, the multicomponent intervention WebChoice had additional positive effects.

Trial Registration

Clinicaltrials.gov:{"type":"clinical-trial","attrs":{"text":"NCT00971009","term_id":"NCT00971009"}}NCT00971009; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT00971009","term_id":"NCT00971009"}}NCT00971009 (Archived by WebCite at http://www.webcitation.org/6USKezP0Y).     

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).