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Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms.

ABSTRACT: OBJECTIVE:This study aims to examine whether the effects of internet interventions for depression generalise to participants recruited in clinical settings. DESIGN:This study uses subgroup analysis of the results of a randomised, controlled, single-blind trial. SETTING:The study takes place in five diagnostic centres in Germany. PARTICIPANTS:A total of 1013 people with mild to moderate depressive symptoms were recruited from clinical sources as well as internet forums, statutory insurance companies and other sources. INTERVENTIONS:This study uses either care-as-usual alone (control) or a 12-week internet intervention (Deprexis) plus usual care (intervention). MAIN OUTCOME MEASURES:The primary outcome measure was self-rated depression severity (Patient Health Questionnaire-9) at 3 months and 6 months. Further measures ranged from demographic and clinical parameters to a measure of attitudes towards internet interventions (Attitudes towards Psychological Online Interventions Questionnaire). RESULTS:The recruitment source was only associated with very few of the examined demographic and clinical characteristics. Compared with participants recruited from clinical sources, participants recruited through insurance companies were more likely to be employed. Clinically recruited participants were as severely affected as those from other recruitment sources but more sceptical of internet interventions. The effectiveness of the intervention was not differentially associated with recruitment source (treatment by recruitment source interaction=0.28, p=0.84). CONCLUSION:Our results support the hypothesis that the intervention we studied is effective across different recruitment sources including clinical settings. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov NCT01636752.

SUBMITTER: Klein JP

PROVIDER: S-EPMC5734368 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms.

Klein Jan Philipp JP Gamon Carla C Späth Christina C Berger Thomas T Meyer Björn B Hohagen Fritz F Hautzinger Martin M Lutz Wolfgang W Vettorazzi Eik E Moritz Steffen S Schröder Johanna J

BMJ open 20170713 7

<h4>Objective</h4>This study aims to examine whether the effects of internet interventions for depression generalise to participants recruited in clinical settings.<h4>Design</h4>This study uses subgroup analysis of the results of a randomised, controlled, single-blind trial.<h4>Setting</h4>The study takes place in five diagnostic centres in Germany.<h4>Participants</h4>A total of 1013 people with mild to moderate depressive symptoms were recruited from clinical sources as well as internet forum ...[more]

PMID: 28710212

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Project description:ObjectiveTo explore the moderating effects of sociodemographic variables on treatment benefits received from participating in an internet intervention for depression.DesignRandomised, assessor-blind, controlled trial.SettingOnline intervention, with participant recruitment using multiple settings, including inpatient and outpatient medical and psychological clinics, depression online forums, health insurance companies and the media (eg, newspaper, radio).ParticipantsThe EVIDENT trial included 1013 participants with mild to moderate depressive symptoms.InterventionsThe intervention group subjects (n=509) received an online intervention (Deprexis) in addition to care as usual (CAU), while 504 participants received CAU alone.MethodsTo explore subgroup differences, moderating effects were investigated using linear regression models based on intention-to-treat analyses. Moderating effects included sex, age, educational attainment, employment status, relationship status and lifetime frequency of episodes.Primary and secondary outcome measuresThe primary endpoint was change in self-rated depression severity measured by the Patient Health Questionnaire-9 (PHQ-9), comparing baseline versus 12-week post-test assessment. Secondary outcome measures were the Hamilton Rating Scale for Depression and the Quick Inventory of Depressive Symptoms each at 12 weeks and at 6 and 12 months, and PHQ-9 at 6 and 12 months, respectively. In this article, we focus on the primary outcome measure only.ResultsBetween-group differences were observed in post-test scores, indicating the effectiveness of Deprexis. While the effects of the intervention could be demonstrated across all subgroups, some showed larger between-group differences than others. However, after exploring the moderating effects based on linear regression models, none of the selected variables was found to be moderating treatment outcomes.ConclusionsOur findings suggest that Deprexis is equally beneficial to a wide range of people; that is, participant characteristics were not associated with treatment benefits. Therefore, participant recruitment into web-based psychotherapeutic interventions should be broad, while special attention may be paid to those currently under-represented in these interventions.Trial registration numberNCT01636752.

Project description:IntroductionDepression is a highly prevalent condition with typical onset in early adulthood. Internet-delivered cognitive behavioural therapy (iCBT) is a promising cost-effective and more widely available alternative to face-to-face CBT. However, it is not known whether it can reduce sickness absence in employees showing depressive symptoms. The randomised controlled trial component of the DAQI (Depression and sickness absence in young adults: a quasi-experimental trial and web-based treatment intervention) project aims to investigate if iCBT is effective in reducing sickness absence compared with care as usual (CAU) among young employees with depressive symptoms in primary care provided in an occupational health setting.Methods and analysisThis study will use a randomised controlled single-centre service-based trial of an existing iCBT programme (Mental Hub iCBT for Depression) to evaluate whether or not this treatment can reduce the number of sickness absence days in public sector employees aged 18-34 years who present at the occupational health service with mild depressive symptoms (score ≥9 on the Beck Depression Inventory-IA). Control participants will be offered CAU, with no constraints regarding the range of treatments. The active condition will consist of seven weekly modules of iCBT, with support from a web therapist. Primary outcome will be participants' all-cause sickness absence as indicated in employer's and national administrative records up to 6 months from study entry. Secondary outcomes relating to long-term sickness absence (over 11 calendar days) for mental and musculoskeletal disorders and psychotropic medication use will be obtained from the Finnish Social Insurance Institution's administrative records; and short sickness absence spells (up to 11 calendar days) will be extracted from employer's records. Analyses will be conducted on an intention-to-treat basis.Ethics and disseminationThe Coordinating Ethics Committee of the Hospital District of Helsinki and Uusimaa has approved the study (HUS/974/2019). The results will be published in peer-reviewed scientific journals and in publications for lay audience.Trial registration numberISRCTN10877837.

Project description:Poor mental health is a growing concern among young people during the coronavirus disease 2019 (COVID-19) pandemic. The aim of this study was to assess the associations of Internet addiction with depressive symptoms, anxiety symptoms, and stress in higher education students during the COVID-19 pandemic, as well as to examine these mental health problems in the context of study-related characteristics. The research sample consisted of 3,099 participants from the Czech Republic (CZ: 1,422) and Slovak Republic (SK: 1,677). The Internet Addiction Test (IAT), the Generalized Anxiety Disorder (GAD-7) scale, the Patient Health Questionnaire for depressive symptoms (PHQ-9), and the Perceived Stress Scale (PSS) were used to measure mental health problems. The analyses also included demographic data (gender and age) and study-related characteristics (form of study, degree of study, field of study, distance between college and home, and housing during the semester). Based on the results of frequency and descriptive analyses, the prevalence of mental health problems was high. The most serious levels of Internet addiction (IAT cut-off point ≥ 50), to which attention should be paid, were found in 3.5% of Czech and 6.2% of Slovak students. Using the standard cut-off point of GAD-7 ≥ 10, 14.1% of Czech and 11.6% of Slovak students were identified with anxiety symptoms. Regarding the PHQ-9 with the cut-off point ≥ 10, 23.4% of Czech and 19.1% of Slovak students had depressive symptoms, which should be addressed. Using the PSS cut-off point ≥ 27, 12.9% of Czech students and 9.1% of Slovak students perceived high stress. The quantile regression analysis showed that Internet addiction was positively associated with anxiety symptoms, depressive symptoms, and stress in all of the analyzed cases (p-value < 0.001). In terms of study-related characteristics, the binomial logistic regression analysis revealed that risk factors for mental health problems in Czech and Slovak students were mainly full-time form of study and living away from home during the semester. Internet addiction, anxiety symptoms, depressive symptoms, and stress are issues that require increased attention, and professionals and policy-makers should implement interventions to effectively prevent and help students with psychological problems.

Project description:BACKGROUND:Depression is a highly prevalent mental health issue that exacts significant economic, societal, personal, and interpersonal costs. Innovative internet-delivered interventions have been designed to increase accessibility to and cost-effectiveness of treatments. These treatments have mainly targeted mild to moderate levels of depression. The increased risk associated with severe depression, particularly of suicidal ideation often results in this population being excluded from research studies. As a result, the effectiveness of internet-delivered cognitive behavioral therapy (iCBT) in more severely depressed cohorts is less researched. OBJECTIVE:The aim of this study is to examine the effect of iCBT on symptoms of severe depression, comorbid symptoms of anxiety, and levels of work and social functioning. METHODS:Retrospective consent was provided by participants with elevated scores (>28 severe depression symptoms) on the Beck Depression Inventory (BDI-II) who accessed an iCBT intervention (Space from Depression) with support for up to 8 weeks. Data were collected at baseline, posttreatment, and 3-month follow-up on the primary outcome (BDI-II), and secondary outcomes (the Generalized Anxiety Disorder-7 and the Work and Social Adjustment Scale). RESULTS:A significant change was observed on all measures between pre- and postmeasurement and maintained at 3-month follow-up. Clinical improvement was observed for participants on the BDI-II from pre- to postmeasurement, and suicidal ideation also reduced from pre- to postmeasurement. CONCLUSIONS:Users of Space from Depression with symptoms of severe depression were found to have decreased symptoms of depression and anxiety and increased levels of work and social functioning. The intervention also demonstrated its potential to decrease suicidal ideation. Further investigation is required to determine why some individuals improve, and others do not. iCBT may have the potential to be used as an adjunct treatment for severe depression symptoms, but participants may require further treatment if they receive iCBT as a standalone intervention. Although promising, further research incorporating control groups is needed to support the utility of Space from Depression for use in or as an adjunct to treatment for severe depression.

Project description:BACKGROUND:Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE:The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS:This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS:Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=-5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=-5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). CONCLUSIONS:This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. TRIAL REGISTRATION:ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215.

Project description:INTRODUCTION:Although exercise therapy has widely been shown to be an efficacious treatment modality for depression, evidence for its effectiveness and cost efficiency is lacking. The Sport/Exercise Therapy for Depression study is a multicentre cluster-randomised effectiveness trial that aims to compare the effectiveness and cost efficiency of exercise therapy and psychotherapy as antidepressant treatment. METHODS AND ANALYSIS:480 patients (aged 18-65) with an International Classification of Diseases diagnosis associated with depressive symptoms are recruited. Up to 30 clusters (psychotherapists) are randomly assigned to allocate patients to either an exercise or a psychotherapy treatment as usual in a 2:1 ratio. The primary outcome (depressive symptoms) and the secondary outcomes (work and social adjustment, quality of life) will be assessed at six measurement time points (t0: baseline, t1: 8 weeks after treatment initiation, t2: 16 weeks after treatment initiation, t3/4/5: 2, 6, 12 months after treatment). Linear regression analyses will be used for the primary endpoint data analysis. For the secondary endpoints, mixed linear and logistic regression models with fixed and random factors will be added. For the cost efficiency analysis, expenditures in the 12 months before and after the intervention and the outcome difference will be compared between groups in a multilevel model. Recruitment start date was 1 July 2018 and the planned recruitment end date is 31 December 2020. ETHICS AND DISSEMINATION:The study protocol was approved by the ethics committee of the University of Potsdam (No. 17/2018) and the Freie Universität Berlin (No. 206/2018) and registered in the ISRCTN registry. Informed written consent will be obtained from all participants. The study will be reported in accordance with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials statements. The results will be published in peer-reviewed academic journals and disseminated to the public. TRIAL REGISTRATION NUMBER:ISRCTN28972230.

Dataset Information

Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms.

Publications

Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms.

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