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Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Protocol for a randomized controlled trial.

ABSTRACT: Preventing recurrence of depression forms an important challenge for current treatments. Cognitive control impairments often remain present during remission of depression, putting remitted depressed patients at heightened risk for new depressive episodes by disrupting emotion regulation processes. Importantly, research indicates that cognitive control training targeting working memory functioning shows potential in reducing maladaptive emotion regulation and depressive symptomatology in clinically depressed patients and at-risk student samples. The current study aims to test the effectiveness of cognitive control training as a preventive intervention in a remitted depressed sample, exploring effects of cognitive control training on rumination and depressive symptomatology, along with indicators of adaptive emotion regulation and functioning.We present a double blind randomized controlled design. Remitted depressed adults will complete 10 online sessions of a cognitive control training targeting working memory functioning or a low cognitive load training (active control condition) over a period of 14 days. Effects of training on primary outcome measures of rumination and depressive symptomatology will be assessed pre-post training and at three months follow-up, along with secondary outcome measure adaptive emotion regulation. Long-term effects of cognitive control training on broader indicators of functioning will be assessed at three months follow-up (secondary outcome measures).This study will provide information about the effectiveness of cognitive control training for remitted depressed adults in reducing vulnerability for depression. Furthermore, this study will address key questions concerning the mechanisms underlying the effects of cognitive control training, will take into account the subjective experience of the patients (including a self-report measure for cognitive functioning), and explore whether these effects extend to broad measures of functioning such as Quality of Life and disability.This study is registered with ClinicalTrials.Gov, number NCT02407652 .

SUBMITTER: Hoorelbeke K

PROVIDER: S-EPMC4459439 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Project description:IntroductionMajor depressive disorder (MDD) affects 163 million people globally every year. Individuals who experience subsyndromal depressive symptoms during remission (ie, partial remission of MDD) are especially at risk for a return to a depressive episode within an average of 4 months. Simultaneously, partial remission of MDD is associated with work and (psycho)social impairment and a lower quality of life. Brief psychological interventions such as preventive cognitive therapy (PCT) can reduce depressive symptoms or relapse for patients in partial remission, although achieving full remission with treatment is still a clinical challenge. Treatment might be more effective if cognitive functioning of patients is targeted as well since cognitive problems are the most persisting symptom in partial remission and predict poor treatment response and worse functioning. Studies show that cognitive functioning of patients with (remitted) MDD can be improved by online neurocognitive remediation therapy (oNCRT). Augmenting oNCRT to PCT might improve treatment effects for these patients by strengthening their cognitive functioning alongside a psychological intervention.Methods and analysisThis study will examine the effectiveness of augmenting oNCRT to PCT in a pragmatic national multicentre superiority randomised controlled trial. We will include 115 adults partially remitted from MDD with subsyndromal depressive symptoms defined as a Hamilton Depression Rating Scale score between 8 and 15. Participants will be randomly allocated to PCT with oNCRT, or PCT only. Primary outcome measure is the effect on depressive symptomatology over 1 year. Secondary outcomes include time to relapse, cognitive functioning, quality of life and healthcare costs. This first dual approach study of augmenting oNCRT to PCT might facilitate full remission in partially remitted individuals as well as prevent relapse over time.Ethics and disseminationEthical approval was obtained by Academic Medical Center, Amsterdam. Outcomes will be made publicly available.Trial registration numberNL9582.

Project description:BackgroundThe high prevalence of major depressive disorder in adolescents and the low rate of successful treatment highlight a pressing need for accessible, affordable adolescent depression prevention programs. The Internet offers opportunities to provide adolescents with high quality, evidence-based programs without burdening or creating new care delivery systems. Internet-based interventions hold promise, but further research is needed to explore the efficacy of these approaches and ways of integrating emerging technologies for behavioral health into the primary care system.Methods/designWe developed a primary care Internet-based depression prevention intervention, Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training (CATCH-IT), to evaluate a self-guided, online approach to depression prevention and are conducting a randomized clinical trial comparing CATCH-IT to a general health education Internet intervention. This article documents the research framework and randomized clinical trial design used to evaluate CATCH-IT for adolescents, in order to inform future work in Internet-based adolescent prevention programs. The rationale for this trial is introduced, the current status of the study is reviewed, and potential implications and future directions are discussed.DiscussionThe current protocol represents the only current, systematic approach to connecting at-risk youth with self-directed depression prevention programs in a medical setting. This trial undertakes the complex public health task of identifying at-risk individuals through mass screening of the general primary care population, rather than solely relying on volunteers recruited over the Internet, and the trial design provides measures of both symptomatic and diagnostic clinical outcomes. At the present time, we have enrolled N = 234 adolescents/expected 400 and N = 186 parents/expected 400 in this trial, from N = 6 major health systems. The protocol described here provides a model for a new generation of interventions that blend substantial computer-based instruction with human contact to intervene to prevent mental disorders such as depression. Because of the potential for broad generalizability of this model, the results of this study are important, as they will help develop the guidelines for preventive interventions with youth at-risk for the development of depressive and other mental disorders.Trial registrationClinical trial registryNCT01893749 date 6 May 2012.

Project description:BackgroundMajor depression is a highly prevalent disorder causing severe personal distress, and high societal costs. Patients with depression often have comorbid insomnia disorder (ID) leading to even worse personal distress and worse treatment outcomes. Recent results from a non-randomised pilot study with internet-delivered Cognitive Behavioural Therapy (CBTi) for Insomnia (I-Sleep) added to regular depression care were promising regarding feasibility and initial effects on insomnia complaints and depression. However, no randomised controlled trial (RCT) has been performed yet to access the (cost-) effectiveness of I-Sleep for depression. Therefore, this protocol article presents the design of an RCT aimed to assess the (cost-) effectiveness of I-Sleep in addition to usual care for depression compared to usual care alone in depressed patients with a comorbid Insomnia Disorder (ID) treated at outpatient clinics for mood disorders. METHODS /DESIGN: This is a multi-centre RCT with measurements at baseline and at 3, 6, 9, and 12 months of follow-up. Patients with depression and an ID are randomised to either I-Sleep treatment followed by regular depression care or to regular depression care alone. Our aim is to recruit one hundred and seventy-five patients from multiple outpatient clinics for mood disorders. The primary outcome is the change in depressive symptoms over 12 months of follow-up measured with the Patient Health Questionnaire (PHQ-9). Secondary outcomes are recovery from depression (PHQ-9), insomnia severity (Insomnia Severity Index, ISI), daily functioning (Work and Social Adjustment Scale, WSAS), general quality of life (EuroQol 5-level version, EQ-5D-5L), and societal costs (Adapted versions of the iMTA Productivity Cost Questionnaire, iPCQ and iMTA Medical Cost Questionnaire, iMCQ).DiscussionWe hypothesize that the addition of I-Sleep to usual care will result in a significant improvement in depression treatment outcomes and quality of life as well as a decrease in healthcare and societal costs compared to usual care alone. This study is the first pragmatic RCT evaluating the effectiveness and cost-effectiveness of adding CBTi to usual care for depression.Trial registrationNetherlands Trial Register (NL8955). Registered on October 6th2020. https://trialsearch.who.int/Trial2.aspx?TrialID=NL8955.

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:BackgroundInternet-delivered interventions can provide remarkable opportunities in addressing breast cancer survivors' unmet support care needs, as they present an effective strategy to improve care coordination and provide access to efficacious, cost-efficient and convenient survivorship care. Nevertheless, research focusing on improving survivors' psychosocial needs using internet-based tools is scarce and its practical implementation is limited.ObjectivesTo study the acceptability, feasibility, efficacy and cost-effectiveness of iNNOVBC, a 10 weeks guided internet-delivered individually-tailored Acceptance and Commitment Therapy (ACT)-influenced cognitive behavioural (CBT) intervention developed to improve mild to moderate anxiety and depression in Breast cancer survivors when compared to treatment as usual (TAU) in a waiting list control group (WLC).MethodsA two-arm, parallel, open label, multicentre, waiting list randomized controlled trial will be conducted to investigate the efficacy and cost-effectiveness of INNOVBC. The primary outcomes in this research will be anxiety and depression. Secondary outcomes will include psychological flexibility, fatigue, insomnia, sexual dysfunction and Health Related Quality of Life (HRQoL).Ethical approvalThis study has been reviewed and approved by Comissão Nacional de Proteção de Dados; Instituto Português de Oncologia do Porto Francisco Gentil; Unidade Local de Saúde de Matosinhos, EPE; Centro Hospitalar de São João and Ordem dos Psicólogos ethical committees.Expected resultsIt is anticipated that iNNOVBC will show to be an efficacious and cost-effective program in improving the outcomes of interest in this study, as opposed to a WLC under TAU. The results of this research will be published in accordance with CONSORT-EHEALTH guidelines.ConclusionsThis study will inform on the acceptability, feasibility, efficacy and cost-effectiveness of iNNOVBC, in improving psychosocial outcomes in breast cancer survivors when compared to TAU in a WLC. Its conclusions will contribute to understand the idiosyncrasies of designing and implementing internet-delivered interventions in breast cancer survivors.Trial Registration code: INNOVBC (NCT03275727).

Project description:BackgroundCancer survivors are vulnerable to experiencing symptoms of anxiety and depression and may benefit from accessible interventions focused on improving emotion regulation. CanCope Mind (CM) was developed as an internet-delivered intervention adapted from the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders to improve emotion regulation and support the mental health of cancer survivors.ObjectiveThis protocol aims to provide an outline of the CanCope Study, a trial comparing the efficacy of a Unified Protocol-adapted internet-delivered intervention (CM) designed for cancer survivors compared with an active control condition-an internet-delivered healthy lifestyle intervention, CanCope Lifestyle (CL). The primary aim is to assess and compare the efficacy of both interventions in improving emotion regulation, anxiety and depressive symptoms, and quality of life. The secondary aims involve assessing the mechanisms of the CM intervention.MethodsThis trial is a 2-arm randomized controlled trial that allocates cancer survivors to either CM or CL. Both interventions comprise 4 web-based modules and are expected to take participants at least 8 weeks to complete. Participants' mental and physical health will be assessed via self-reported surveys at baseline (T0), between each module (T1, T2, and T3), immediately after the intervention (T4), and at 3-month follow-up (T5). The study aims to recruit 110 participants who have completed T4.ResultsThe CanCope study began recruitment in September 2020. A total of 224 participants have been randomized to the CM (n=110, 49.1%) and CL (n=114, 50.9%) groups.ConclusionsThis is one of the first trials to develop and investigate the efficacy of a web-based intervention for cancer survivors that specifically targets emotion regulation.Trial registrationAustralian Clinical Trials ACTRN12620000943943; https://tinyurl.com/b3z9cjsp.International registered report identifier (irrid)DERR1-10.2196/36658.

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Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Protocol for a randomized controlled trial.

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