Overcoming Depression on the Internet (ODIN) (2): A Randomized Trial of a Self-Help Depression Skills Program With Reminders
ABSTRACT Guided self-help programs for depression (with associated therapist contact) have been successfully delivered over the Internet. However, previous trials of pure self-help Internet programs for depression (without therapist contact), including an earlier trial conducted by us, have failed to yield positive results. We hypothesized that methods to increase participant usage of the intervention, such as postcard or telephone reminders, might result in significant effects on depression.
This paper presents a second randomized trial of a pure self-help Internet site, ODIN (Overcoming Depression on the InterNet), for adults with self-reported depression. We hypothesized that frequently reminded participants receiving the Internet program would report greater reduction in depression symptoms and greater improvements in mental and physical health functioning than a comparison group with usual treatment and no access to ODIN.
This was a three-arm randomized control trial with a usual treatment control group and two ODIN intervention groups receiving reminders through postcards or brief telephone calls. The setting was a nonprofit health maintenance organization (HMO). We mailed recruitment brochures by US post to two groups: adults (n = 6030) who received depression medication or psychotherapy in the previous 30 days, and an age- and gender-matched group of adults (n = 6021) who did not receive such services. At enrollment and at 5-, 10- and 16-weeks follow-up, participants were reminded by email (and telephone, if nonresponsive) to complete online versions of the Center for Epidemiological Studies Depression Scale (CES-D) and the Short Form 12 (SF-12). We also recorded participant HMO health care services utilization in the 12 months following study enrollment.
Out of a recruitment pool of 12051 approached subjects, 255 persons accessed the Internet enrollment site, completed the online consent form, and were randomized to one of the three groups: (1) treatment as usual control group without access to the ODIN website (n = 100), (2) ODIN program group with postcard reminders (n = 75), and (3) ODIN program group with telephone reminders (n = 80). Across all groups, follow-up completion rates were 64% (n = 164) at 5 weeks, 68% (n = 173) at 10 weeks, and 66% (n = 169) at 16 weeks. In an intention-to-treat analysis, intervention participants reported greater reductions in depression compared to the control group (P = .03; effect size = 0.277 standard deviation units). A more pronounced effect was detected among participants who were more severely depressed at baseline (P = .02; effect size = 0.537 standard deviation units). By the end of the study, 20% more intervention participants moved from the disordered to normal range on the CES-D. We found no difference between the two intervention groups with different reminders in outcomes measures or in frequency of log-ons. We also found no significant intervention effects on the SF-12 or health care services.
In contrast to our earlier trial, in which participants were not reminded to use ODIN, in this trial we found a positive effect of the ODIN intervention compared to the control group. Future studies should address limitations of this trial, including relatively low enrollment and follow-up completion rates, and a restricted number of outcome measures. However, the low incremental costs of delivering this Internet program makes it feasible to offer this type of program to large populations with widespread Internet access.
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ABSTRACT: A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder. The combined diseases have a wide range of adverse outcomes, such as a lower quality of life, poorer diabetes outcomes and increased healthcare utilisation. Diabetes patients with depression can be treated effectively with psychotherapy, but access to psychological care is limited. In this study we will examine the efficacy and cost-effectiveness of a newly developed web-based intervention (GET.ON Mood Enhancer Diabetes) for people with diabetes and comorbid depressive symptoms. A two-arm randomised controlled trial will be conducted. Adults with diabetes (type 1 or type 2) with increased depression scores (> 22 on the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) will be included. Eligible participants will be recruited through advertisement in diabetes patient journals and via a large-scale German health insurance company. The participants will be randomly assigned to either a 6-week minimally guided web-based self-help program or an online psychoeducation program on depression. The study will include 260 participants, which will enable us to detect a statistically significant difference with a group effect size of d = 0.35 at a power of 80% and a significance level of p = 0.05. The primary outcome measure will be the level of depression as assessed by the CES-D. The secondary outcome measures will be: diabetes-specific emotional distress, glycaemic control, self-management behaviour and the participants' satisfaction with the intervention. Online self-assessments will be collected at baseline and after a 2 months period, with additional follow-up measurements 6 and 12 months after randomisation. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct an economic evaluation from a societal perspective. If this intervention is shown to be cost-effective, it has considerable potential for implementing psychological care for large numbers of people with diabetes and comorbid depression in routine practice and improve health outcomes.Trial registrationGerman Clinical Trial Register (DRKS): DRKS00004748.BMC Psychiatry 11/2013; 13(1):306. DOI:10.1186/1471-244X-13-306 · 2.24 Impact Factor
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ABSTRACT: In the past decade, a large body of research has demonstrated that internet-based interventions can have beneficial effects on depression. However, only a few clinical trials have compared internet-based depression therapy with an equivalent face-to-face treatment. The primary aim of this study was to compare treatment outcomes of an internet-based intervention with a face-to-face intervention for depression in a randomized non-inferiority trial. A total of 62 participants suffering from depression were randomly assigned to the therapist-supported internet-based intervention group (n=32) and to the face-to-face intervention (n=30). The 8 week interventions were based on cognitive-behavioral therapy principles. Patients in both groups received the same treatment modules in the same chronological order and time-frame. Primary outcome measure was the Beck Depression Inventory-II (BDI-II); secondary outcome variables were suicidal ideation, anxiety, hopelessness and automatic thoughts. The intention-to-treat analysis yielded no significant between-group difference (online vs. face-to-face group) for any of the pre- to post-treatment measurements. At post-treatment both treatment conditions revealed significant symptom changes compared to before the intervention. Within group effect sizes for depression in the online group (d=1.27) and the face-to-face group (d=1.37) can be considered large. At 3-month follow-up, results in the online group remained stable. In contrast to this, participants in the face-to-face group showed significantly worsened depressive symptoms three months after termination of treatment (t=-2.05, df=19, p<.05). Due to the small sample size, it will be important to evaluate these outcomes in adequately-powered trials. This study shows that an internet-based intervention for depression is equally beneficial to regular face-to-face therapy. However, more long term efficacy, indicated by continued symptom reduction three months after treatment, could be only be found for the online group.Journal of Affective Disorders 07/2013; 152. DOI:10.1016/j.jad.2013.06.032 · 3.71 Impact Factor
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ABSTRACT: PURPOSE: Computerized cognitive behaviour therapy (cCBT) is becoming an increasingly well-recognized therapeutic option for the treatment of depression. With acknowledged high prevalence of depression within chronic physical ill-health populations and a need to increase access to psychological therapies, cCBT represents a low-intensity intervention with the potential to have great utility within health care settings. METHODS: This article systematically reviews the evidence for the effectiveness of cCBT for the treatment of depression with people who have a chronic physical health problem. A comprehensive search was conducted to identify relevant randomized, controlled trials. Identified studies were quality-assessed, and data were extracted by two reviewers. RESULTS: One study investigating cCBT for the treatment of depression in people with diabetes fulfilled inclusion criteria. The trial reported positive outcomes compared to a waiting-list control condition. CONCLUSIONS: The available literature suggests cCBT programmes may be beneficial for populations with a chronic physical illness experiencing depression. This conclusion is based on the findings of a single study, which involved the evaluation of a cCBT package by its developers, included a short follow-up and featured specialist health care support. Additionally, the study reported considerable attrition suggesting the intervention might not have been acceptable to many participants. It is likely that cCBT may be a way in which to increase access to psychological therapies. However, prior to any definitive conclusions being made, further high-quality research to establish the acceptability, feasibility, efficacy, and effectiveness of cCBT for specific chronic physical health conditions is required. STATEMENT OF CONTRIBUTION: What is already known on this subject? Computerized cognitive behaviour therapy (cCBT) is increasingly being utilized as a low-intensity treatment for depression within general adult populations following positive randomized, controlled trials of both commercial and free-to-use programmes. There is potential application for such programmes in addressing the high prevalence of depression within physically ill populations. However, to date, there has been no attempt to review the literature regarding the application of cCBT to treat depression in people with a chronic physical illness. What does this study add? Fifty-six studies were identified and screened for inclusion in the present systematic review. One RCT, applying cCBT to a diabetes population, fulfilled inclusion criteria. Development of complex interventions should be guided by a recognized flexible, phased framework.British Journal of Health Psychology 12/2012; DOI:10.1111/bjhp.12014 · 2.70 Impact Factor