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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:BackgroundThere has been an increased need to provide specialized help for people with depressive and anxiety symptoms, particularly teenagers and young adults. There is evidence from a 2-week intervention that chatbots (eg, Woebot) are effective in reducing depression and anxiety, an effect that was not detected in the control group that was provided self-help materials. Although chatbots are a promising solution, there is limited scientific evidence for the efficacy of agent-guided cognitive behavioral therapy (CBT) outside the English language, especially for highly inflected languages.ObjectiveThis study aimed to measure the efficacy of Fido, a therapy chatbot that uses the Polish language. It targets depressive and anxiety symptoms using CBT techniques. We hypothesized that participants using Fido would show a greater reduction in anxiety and depressive symptoms than the control group.MethodsWe conducted a 2-arm, open-label, randomized controlled trial with 81 participants with subclinical depression or anxiety who were recruited via social media. Participants were divided into experimental (interacted with a fully automated Fido chatbot) and control (received a self-help book) groups. Both intervention methods addressed topics such as general psychoeducation and cognitive distortion identification and modification via Socratic questioning. The chatbot also featured suicidal ideation identification and redirection to suicide hotlines. We used self-assessment scales to measure primary outcomes, including the levels of depression, anxiety, worry tendencies, satisfaction with life, and loneliness at baseline, after the 2-week intervention and at the 1-month follow-up. We also controlled for secondary outcomes, including engagement and frequency of use.ResultsThere were no differences in anxiety and depressive symptoms between the groups at enrollment and baseline. After the intervention, depressive and anxiety symptoms were reduced in both groups (chatbot: n=36; control: n=38), which remained stable at the 1-month follow-up. Loneliness was not significantly different between the groups after the intervention, but an exploratory analysis showed a decline in loneliness among participants who used Fido more frequently. Both groups used their intervention technique with similar frequency; however, the control group spent more time (mean 117.57, SD 72.40 minutes) on the intervention than the Fido group (mean 79.44, SD 42.96 minutes).ConclusionsWe did not replicate the findings from previous (eg, Woebot) studies, as both arms yielded therapeutic effects. However, such results are in line with other research of Internet interventions. Nevertheless, Fido provided sufficient help to reduce anxiety and depressive symptoms and decreased perceived loneliness among high-frequency users, which is one of the first pieces of evidence of chatbot efficacy with agents that use a highly inflected language. Further research is needed to determine the long-term, real-world effectiveness of Fido and its efficacy in a clinical sample.Trial registrationClinicalTrials.gov NCT05762939; https://clinicaltrials.gov/study/NCT05762939; Open Science Foundation Registry 2cqt3; https://osf.io/2cqt3.

Project description:BackgroundDepression, 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.MethodIn 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.ResultsWe 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.DiscussionDepression 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).

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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