Internet-based treatment for adults with depressive symptoms: the protocol of a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Depression is a highly prevalent condition, affecting more than 15% of the adult population at least once in their lives. Guided self-help is effective in the treatment of depression. The purpose of this study is to investigate the effectiveness of two Internet-based guided self-help treatments with adults reporting elevated depressive symptoms. Other research questions concern the identification of potential mediators and the search for subgroups who respond differently to the interventions.</p> <p>Methods</p> <p>This study is a randomized controlled trial with three conditions: two treatment conditions and one waiting list control group. The two treatment conditions are Internet-based cognitive behavior therapy and Internet-based problem-solving therapy. They consist of 8 and 5 weekly lessons respectively. Both interventions are combined with support by e-mail. Participants in the waiting list control group receive the intervention three months later.</p> <p>The study population consists of adults from the general population. They are recruited through advertisements in local and national newspapers and through banners on the Internet. Subjects with symptoms of depression (≥ 16 on the Center for Epidemiological Studies Depression scale) are included. Other inclusion criteria are having sufficient knowledge of the Dutch language, access to the Internet and an e-mail address.</p> <p>Primary outcome is depressive symptoms. Secondary outcomes are anxiety, quality of life, dysfunctional cognitions, worrying, problem solving skills, mastery, absence at work and use of healthcare. We will examine the following variables as potential mediators: dysfunctional cognitions, problem solving skills, worrying, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics and symptom severity. Data are collected at baseline and at 5 weeks, 8 weeks, 12 weeks and 9 months after baseline. Analyses will be conducted on the intention-to-treat sample.</p> <p>Discussion</p> <p>This study evaluates two Internet-based treatments for depression, namely cognitive behavioral therapy and problem-solving therapy. The effectiveness of Internet-based problem-solving therapy suggest that this may be a worthwhile alternative to other more intensive treatment options. Strengths and limitations of this study are discussed.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN16823487</p

The Mental Vitality @ Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals

Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers' Health Surveillance (WHS) mental module may be an effective strategy to monitor and promote good (mental) health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective. The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group) with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual's mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in both intervention arms will be assessed, and a process evaluation will be performed. When it is proven effective compared to a control group, a WHS mental module for nurses and allied health professionals could be implemented and used on a regular basis by occupational health services in hospitals to improve employees' mental health and work functioning. NTR278

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

Background: Many depressed people do not receive help for their symptoms, and there are various barriers that impede help-seeking. The Internet may offer interesting alternatives for reaching and helping people with depression. Depression can be treated effectively with Internet-based cognitive behavioral therapy (CBT), but a short intervention based on problem solving therapy (PST) could constitute a worthwhile alternative to CBT. Objective: In this study we evaluated the effectiveness of Internet-based CBT and Internet-based PST in comparison to a waiting list control group (WL), and we determined the differences between the two treatments. Methods: We conducted a 3-arm randomized controlled trial to compare CBT, PST, and WL. The main inclusion criterion was presence of depressive symptoms (≥ 16 on the Center for Epidemiological Studies Depression scale). CBT and PST consisted of eight and five weekly lessons respectively. Participants were supported by email. Self-report measures of depression, anxiety, and quality of life were completed at pretest and after 5, 8, and 12 weeks. Results: A total of 263 participants were randomized to the three conditions (CBT: n=88; PST: n=88; WL: n=87). Of the 263 participants, 184 (70%) completed questionnaires after 5 weeks, 173 (66%) after 8 weeks, and 151 (57%) after 12 weeks. Between-group effect sizes for depressive symptoms were 0.54 for CBT after 8 weeks (95% confidence interval (CI): 0.25 - 0.84) and 0.47 for PST after 5 weeks (95% CI: 0.17 - 0.77). These effects were further improved at 12 weeks (CBT: 0.69, 95% CI: 0.41 - 0.98; PST: 0.65, 95% CI: 0.36 - 0.95). For anxiety, effect sizes were also at a medium level. Effect sizes for quality of life were low. The number of participants showing clinically significant change at 12 weeks was significantly higher for CBT (n = 34, 38.6%) and PST (n = 30, 34.1%), compared to WL (n = 0). Conclusions: Both Internet-based treatments are effective in reducing depressive symptoms, although the effect of PST is realized more quickly. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 16823487; http://www.controlled-trials.com/ ISRCTN16823487/16823487 (Archived by WebCite at http://www.webcitation.org/ 5cQsOj7xf). © Lisanne Warmerdam, Annemieke van Straten, Jos Twisk, Heleen Riper, Pim Cuijpers

Cost-Utility and Cost-Effectiveness of Internet-Based Treatment for Adults With Depressive Symptoms: Randomized Trial

Background: The effectiveness of Internet-based treatments for depression has been demonstrated; their cost-effectiveness, however, has been less well researched. Objective: Evaluating the relative cost-utility and cost-effectiveness of (1) Internet-based cognitive behavioral therapy, (2) Internet-based problem-solving therapy, and (3) a waiting list for adults with depressive symptoms. Methods: A total of 263 participants with clinically significant depressive symptoms were randomized to Internet-based cognitive behavioral therapy (n = 88), Internet-based problem-solving therapy (n = 88), and a waiting list (n = 87). End points were evaluated at the 12-week follow-up. Results: Cost-utility analysis showed that cognitive behavioral therapy and problem-solving therapy had a 52% and 61% probability respectively of being more acceptable than waiting when the willingness to pay is € 30,000 for one quality-adjusted life-year. When society is prepared to pay € 10,000 for a clinically significant change from depression, the probabilities of cognitive behavioral therapy and problem-solving therapy being more acceptable than waiting are 91% and 89%, respectively. Comparing both Internet-based treatments showed no clear preference for one or the other of the treatments. Conclusions: Both Internet-based treatments have a high probability of being cost-effective with a modest value placed on clinically significant change in depressive symptoms