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Effectiveness of a Web- and Mobile-Guided Psychological Intervention for Depressive Symptoms in Turkey: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:In Turkey, there are serious deficiencies in mental health care. Although depression is highly prevalent, only a small number of people seek professional help. Innovative solutions are needed to overcome this treatment gap. Web-based problem-solving therapy (PST) is an intervention proven to be effective in the treatment of depression, although little is known about its clinical effects in Turkey. OBJECTIVE:This study aims to test the clinical effects of a Web and mobile app of an adapted PST for depressive symptoms among the general population in Turkey. METHODS:Participants will be recruited through announcements in social media and the Middle East Technical University. Adults (18-55 years) with mild to moderate depressive symptoms (Beck Depression Inventory-II [BDI-II] score between 10-29) will be included in the study. Participants with a medium-to-high suicidal risk (according to the Mini-International Neuropsychiatric Interview) will be excluded. A 3-armed randomized controlled trial with a waiting control group will be utilized. A sample size of 444 participants will be randomized across 3 groups. The first experimental group will receive direct access to the Web version of the intervention; the second experimental group will receive direct access to the mobile app of the intervention as well as automated supportive short message service text messages based on PST. The control group consists of a wait-list and will gain access to the intervention 4 months after the baseline. The intervention is based on an existing PST for the Turkish population, Her ?ey Kontrol Alt?nda (H?KA), consisting of 5 modules each with a duration of 1 week and is guided by a clinical psychologist. The primary outcome is change in depressive symptoms measured by the BDI-II. Secondary outcomes include symptoms of anxiety, stress, worry, self-efficacy, and quality of life. Furthermore, satisfaction with, usability and acceptability of the intervention are important features that will be evaluated. All outcomes will take place online through self-assessment at posttest (6-8 weeks after baseline) and at follow-up (4 months after baseline). RESULTS:We will recruit a total of 444 participants with mild to moderate depressive symptoms from March 2018 to February 2019 or until the recruitment is complete. We expect the final trial results to be available by the end of May 2019. This trial is funded by the Scientific and Technological Research Council of Turkey (National Postdoctoral Research Fellowship Programme 2016/1). CONCLUSIONS:Results from this study will reveal more information about the clinical effects of H?KA as well as its applicability in a Turkish setting through the Web and mobile platforms. On the basis of the results, a guided Web- and mobile-based PST intervention might become an appropriate alternative for treating mild to moderate depressive symptoms. TRIAL REGISTRATION:ClinicalTrials.gov NCT03754829; https://clinicaltrials.gov/ct2/show/NCT03754829 (Archived by WebCite at http://www.webcitation.org/74HugwLo7). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/13239.

SUBMITTER: Unlu Ince B

PROVIDER: S-EPMC6473215 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Effectiveness of a Web- and Mobile-Guided Psychological Intervention for Depressive Symptoms in Turkey: Protocol for a Randomized Controlled Trial.

Ünlü Ince Burçin B Gökçay Didem D Riper Heleen H Cuijpers Pim P

JMIR research protocols 20190405 4

<h4>Background</h4>In Turkey, there are serious deficiencies in mental health care. Although depression is highly prevalent, only a small number of people seek professional help. Innovative solutions are needed to overcome this treatment gap. Web-based problem-solving therapy (PST) is an intervention proven to be effective in the treatment of depression, although little is known about its clinical effects in Turkey.<h4>Objective</h4>This study aims to test the clinical effects of a Web and mobil ...[more]

PMID: 30950802

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Project description:BACKGROUND:Cognitive behavioral therapy (CBT) is frequently used to treat depressive symptoms in people living with HIV. We developed an internet-based cognitive behavioral intervention for people with HIV and depressive symptoms, which was based on an effective self-help booklet. The Web-based intervention was previously found to be effective. OBJECTIVE:The objective of this study was to investigate potential mediators of the Web-based intervention. METHODS:This study was part of a randomized controlled trial, in which the intervention was compared with an attention-only waiting list control condition. Participants were 188 (97 in intervention group and 91 in control group) people with HIV and mild to moderate depressive symptoms recruited in HIV treatment centers in the Netherlands. A total of 22 participants (22/188, 11.7%) in the study were female and 166 (166/188, 88.3%) were male. The average age of the participants was 46.30 years (SD 10.63). The intervention comprised Web-based self-help CBT for 8 weeks, 1 to 2 hours a week, including minimal telephone support from a coach. The participants received Web-based questionnaires at pretest, 3 times during the intervention/or waiting period, and post intervention. The outcome was depressive symptoms. Factors tested as potential mediators were changes in behavioral activation, relaxation, the cognitive coping strategies catastrophizing and positive refocusing, goal re-engagement, and coping self-efficacy. RESULTS:Using multilevel structural equation modeling, changes in behavioral activation (P=.006) and goal re-engagement (P=.009) were found to be significant mediators of the intervention effect. The mediation effect seemed to occur between weeks 3 and 5 for behavioral activation and weeks 1 and 3 for goal re-engagement. Using (bivariate) autoregressive latent trajectory analysis, we found a return effect (from the dependent variable to the mediator) for goal re-engagement but not for behavioral activation, which suggested that the mediation effect of changes in behavioral activation was stronger than that in goal re-engagement. CONCLUSIONS:The results suggest that changes in behavioral activation and goal re-engagement may mediate the effect of the Web-based intervention for people with HIV and depressive symptoms. The results may lead to possible mechanisms of change of the intervention and improvement of therapy outcomes. TRIAL REGISTRATION:Netherlands Trial Register NTR5407; https://www.trialregister.nl/trial/5298.

Project description:Background:Depression, as one of the most prevalent mental disorders, is expected to become a leading cause of disability. While evidence-based treatments are not always easily accessible, Internet-based information and self-help appears as a promising approach to improve the strained supply situation by avoiding barriers of traditional offline treatment. User experience in the domain of mental problems therefore emerges as an important research topic. The aim of our study is to investigate the impact of depressive symptoms on subjective and objective measures of web user experience. Method:In this two-part online study (Ntotal = 721) we investigate the relationship between depressive symptoms of web users and basic website characteristics (i.e., content, subjective and objective usability, aesthetics). Participants completed search and memory tasks on different fully-functional websites. In addition, they were asked to evaluate the given websites with standardized measures and were screened for symptoms of depression using the PHQ-9. We used structural equation modeling (SEM) to determine whether depression severity affects users' perception of and performance in using information websites. Results:We found significant associations between depressive symptoms and subjective user experience, specifically of website content, usability, and aesthetics, as well as an effect of content perception on the overall appraisal of a website in terms of the intention to visit it again. Small yet significant negative effects of depression severity on all named subjective website evaluations were revealed, leading to an indirect negative effect on the intention to revisit a website via impaired content perceptions. However, objective task performance was not influenced by depressiveness of users. Discussion:Depression emerges as capable of altering the subjective perception of a website to some extend with respect to the main features content, usability, and aesthetics. The user experience of a website is crucial, especially as it facilitates revisiting a website and thus might be relevant in avoiding drop-out in online interventions. Thus, the biased impression of persons affected by symptoms of depression and resulting needs of those users should be considered when designing and evaluating E-(Mental)-Health-platforms. The high prevalence of some mental disorders such as depression in the general population stresses the need for further investigations of the found effects.

Project description:BackgroundMobile health interventions provide significant strategies for improving access to health services, offering a potential solution to reduce the mental health treatment gap. Economic evaluation of this intervention is needed to help inform local mental health policy and program development.ObjectiveThis paper presents the protocol for an economic evaluation conducted alongside 2 randomized controlled trials (RCTs) to evaluate the cost-effectiveness of a psychological intervention delivered through a technological platform (CONEMO) to treat depressive symptoms in people with diabetes, hypertension, or both.MethodsThe economic evaluation uses a within-trial analysis to evaluate the incremental costs and health outcomes of CONEMO plus enhanced usual care in comparison with enhanced usual care from public health care system and societal perspectives. Participants are patients of the public health care services for hypertension, diabetes, or both conditions in São Paulo, Brazil (n=880) and Lima, Peru (n=432). Clinical effectiveness will be measured by reduction in depressive symptoms and gains in health-related quality of life. We will conduct cost-effectiveness and cost-utility analyses, providing estimates of the cost per at least 50% reduction in 9-item Patient Health Questionnaire scores, and cost per quality-adjusted life year gained. The measurement of clinical effectiveness and resource use will take place over baseline, 3-month follow-up, and 6-month follow-up in the intervention and control groups. We will use a mixed costing methodology (ie, a combination of top-down and bottom-up approaches) considering 4 cost categories: intervention (CONEMO related) costs, health care costs, patient and family costs, and productivity costs. We will collect unit costs from the RCTs and national administrative databases. The multinational economic evaluations will be fully split analyses with a multicountry costing approach. We will calculate incremental cost-effectiveness ratios and present 95% CIs from nonparametric bootstrapping (1000 replicates). We will perform deterministic and probabilistic sensitivity analyses. Finally, we will present cost-effectiveness acceptability curves to compare a range of possible cost-effectiveness thresholds.ResultsThe economic evaluation project had its project charter in June 2018 and is expected to be completed in September 2021. The final results will be available in the second half of 2021.ConclusionsWe expect to assess whether CONEMO plus enhanced usual care is a cost-effective strategy to improve depressive symptoms in this population compared with enhanced usual care. This study will contribute to the evidence base for health managers and policy makers in allocating additional resources for mental health initiatives. It also will provide a basis for further research on how this emerging technology and enhanced usual care can improve mental health and well-being in low- and middle-income countries.Trial registrationClinicalTrials.gov NCT12345678 (Brazil) and NCT03026426 (Peru); https://clinicaltrials.gov/ct2/show/NCT02846662 and https://clinicaltrials.gov/ct2/show/NCT03026426.International registered report identifier (irrid)DERR1-10.2196/26164.

Project description:BackgroundDepression is the most prevalent mental health problem. The need for effective treatments for depression far outstrips the availability of trained mental health professionals. Smartphones and other widely available technologies are increasingly being leveraged to deliver treatments for depression. Whether there are patient characteristics that affect the potency of smartphone interventions for depression is not well understood.ObjectiveThis study aimed to evaluate whether patient characteristics including clinical diagnosis, depression severity, psychosis status, and current use of antidepressant medications impact the effects of an evidence-based smartphone intervention on depressive symptoms.MethodsData were collected as part of a 2-arm randomized controlled trial comparing a multimodal smartphone intervention called FOCUS with a clinic-based intervention. Here, we report on 82 participants assigned to 12 weeks of FOCUS treatment. We conducted assessments of depressive symptoms using the Beck Depression Inventory-second edition (BDI-II) at baseline, postintervention (3 months), and follow-up (6 months). We tested for differences in the amount of improvement in BDI-II scores from baseline to posttreatment and 6-month follow-up between each of the following patient subgroups using 2 (group) × 2 (time) mixed effects models: diagnosis (ie, schizophrenia spectrum disorder vs bipolar disorder vs major depressive disorder), depression severity (ie, minimal-mild vs moderate-severe depression), psychosis status (ie, presence vs absence of psychotic symptoms), and antidepressant use (ie, taking antidepressants vs not taking antidepressants).ResultsThe majority of participants were male (60%, 49/82), African American (65%, 53/82), and middle-aged (mean age 49 years), with a high school education or lower (62%, 51/82). There were no differences in patient demographics across the variables that were used to stratify the analyses. There was a significant group × time interaction for baseline depression severity (F1,76.8=5.26, P=.02 [posttreatment] and F1,77.4=6.56, P=.01 [6-month follow-up]). Participants with moderate or severe depression had significant improvements (t42=3.20, P=.003 [posttreatment] and t42=4.20, P<.001 [6-month follow-up]), but participants with minimal or mild depression did not (t31=0.20, P=.84 [posttreatment] and t30=0.43, P=.67 [6-month follow-up]). There were no significant group × time interactions for diagnosis, psychosis status, or antidepressant medication use. Participants with minimal or mild depression had negligible nonsignificant improvements (<1 point on the BDI-II). Reduction in depression in all other groups was larger (range 1.7-6.5 points on the BDI-II).ConclusionsOur results suggest that FOCUS can be deployed to treat moderate to severe depressive symptoms among people with schizophrenia spectrum disorders, bipolar disorder, and major depressive disorder, in concert with antidepressant medications or without them, in both people with and without active psychotic symptoms. The study results are consistent with research on transdiagnostic models in psychotherapy and extend our knowledge about the potential of transdiagnostic mobile health.Trial registrationClinicalTrials.gov NCT02421965; http://clinicaltrials.gov/ct2/show/NCT02421965 (Archived by WebCite at http://www.webcitation.org/76pyDlvAS).

Project description:BackgroundDepressive symptoms are one of the most common and ever-increasing mental health problems among students worldwide. Conventional treatment options, particularly psychotherapy, do not reach all students in need of help. Internet- and mobile-based interventions are promising alternatives for narrowing the treatment gap.ObjectiveIn the framework of a randomized controlled trial, we aim to investigate the effectiveness, acceptance, and side effects of a self-help smartphone app (MCT & More) based on cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and metacognitive training in a sample of students with self-reported depressive symptoms. Furthermore, we were interested in examining the influence of treatment expectations and attitudes toward internet- and mobile-based interventions on treatment adherence and effectiveness.MethodsA total of 400 students were recruited via open access websites and randomized to either the intervention group (n=200), who received access to the self-help smartphone app MCT & More for a period of 4 weeks, or to a wait-list control group (n=200). The Patient Health Questionnaire-9 (depression) served as the primary outcome parameter, and the Rosenberg Self-esteem Scale (self-esteem) and the global item of the World Health Organization Quality of Life-abbreviated version (quality of life) served as the secondary outcome parameters. The Attitudes Towards Psychological Online Interventions was used to measure attitudes toward internet- and mobile-based interventions. Outcome expectations were assessed using the Patient Questionnaire on Therapy Expectation and Evaluation, and side effects were assessed using the Inventory for Assessing Negative Effects of Psychotherapy.ResultsPer-protocol (PP), complete-case, and intention-to-treat analyses showed a significantly higher reduction in depressive symptoms (PP: F1,222=3.98; P=.047; d=0.26) and a significantly higher increase in self-esteem (PP: F1,220=8.79; P=.003; d=0.40) in the intervention group than in the wait-list control group. Most participants regularly used the self-help smartphone app (91/120, 75.8%, at least once a week). The more positive the attitude toward internet- and mobile-based interventions (r=0.260; P=.004) and the more positive the outcome expectation (r=0.236; P=.009), the more frequently the self-help smartphone app was used.ConclusionsThe effectiveness of the self-help smartphone app MCT & More was demonstrated among students with depressive symptoms compared with a wait-list control group. The app could be offered regularly as a low-threshold intervention to enhance students' health.Trial registrationGerman Clinical Trials Register DRKS00020941; https://tinyurl.com/pr84w6er.

Dataset Information

Effectiveness of a Web- and Mobile-Guided Psychological Intervention for Depressive Symptoms in Turkey: Protocol for a Randomized Controlled Trial.

Publications

Effectiveness of a Web- and Mobile-Guided Psychological Intervention for Depressive Symptoms in Turkey: Protocol for a Randomized Controlled Trial.

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