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Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression.

ABSTRACT: Depression is a sufficiently common sequela of a completed stroke to warrant intervention to improve mood, social, and functional outcome. Pharmacologic trials suggest short-term mood improvement from antidepressant treatment but no studies to date have determined whether these short-term gains can be enhanced and extended by a brief psychosocial/behavioral intervention delivered by advanced practice nurses. In addition, drug trials have not reported on functional outcomes such as limitations in ability, limitations in participation, and overall quality of survival. This randomized controlled trial was designed to evaluate the short- and long-term efficacy of a new brief psychosocial/behavioral intervention adjunctive to antidepressant treatment in reducing poststroke depression and improving functional outcomes.A total of 101 survivors of ischemic stroke with poststroke depression were randomly assigned to receive a brief psychosocial/behavioral intervention plus antidepressant or usual care, including antidepressants.The primary outcome was reduction in depressive symptom severity (Hamilton Depression Rating Scale) at 12 months after stroke. Secondary outcomes were reductions in limitations in activity (Barthel Index), reduction in limitation in participation, and overall stroke impact (Stroke Impact Scale) at 6, 12, and 24 months poststroke. Factors influencing best response to psychosocial intervention were also explored.This article provides detail on the design and treatment methods of this randomized trial in progress. Findings from this study provide important information regarding the long-term efficacy of such a behavioral intervention in reducing poststroke depression and subsequent impaired aspects of psychosocial and physical recovery.

SUBMITTER: Mitchell PH

PROVIDER: S-EPMC2396193 | biostudies-literature | 2008 May-Jun

REPOSITORIES: biostudies-literature

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Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression.

Mitchell Pamela H PH Teri Linda L Veith Richard R Buzaitis Ann A Tirschwell David D Becker Kyra K Fruin Michael M Kohen Ruth R Cain Kevin C KC

Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association 20080501 3

<h4>Background</h4>Depression is a sufficiently common sequela of a completed stroke to warrant intervention to improve mood, social, and functional outcome. Pharmacologic trials suggest short-term mood improvement from antidepressant treatment but no studies to date have determined whether these short-term gains can be enhanced and extended by a brief psychosocial/behavioral intervention delivered by advanced practice nurses. In addition, drug trials have not reported on functional outcomes suc ...[more]

PMID: 18436150

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Project description:BackgroundEvaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. A modified conceptual framework for implementation fidelity was used to guide the analysis.MethodsThis study has an explanatory, sequential two-phase mixed methods design. Quantitative process data were collected longitudinally along with data collection in the RCT. Qualitative process data were collected after the last data collection point of the RCT. Descriptive statistical analyses were conducted to describe the sample, the intervention trajectories, and the adherence measures. A scoring system to clarify quantitative measurement of the levels of implementation was constructed. The qualitative data sources were analyzed separately with a theory-driven content analysis using categories of adherence and potential moderating factors identified in the conceptual framework of implementation fidelity. The quantitative adherence results were extended with the results from the qualitative analysis to assess which potential moderators may have influenced implementation fidelity and in what way.ResultsThe results show that the core components of the intervention were delivered although the intervention trajectories were individualized. Based on the composite score of adherence, results show that 80.1% of the interventions in the RCT were implemented with high fidelity. Although it is challenging to assess the importance of each of the moderating factors in relation to the other factors and to their influence on the adherence measures, participant responsiveness, comprehensiveness of policy description, context, and recruitment appeared to be the most prominent moderating factors of implementation fidelity in this study.ConclusionsThis evaluation of implementation fidelity and the discussion of what constitutes high fidelity implementation of this intervention are crucial in understanding the factors influencing the trial outcome. The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity.Trial registrationClinicalTrials.gov , NCT02338869; registered 10/04/2014.

Project description:BackgroundDepression is often a chronic relapsing condition, with relapse rates of 50-80% in those who have been depressed before. This is particularly problematic for those who become suicidal when depressed since habitual recurrence of suicidal thoughts increases likelihood of further acute suicidal episodes. Therefore the question how to prevent relapse is of particular urgency in this group.Methods/designThis trial compares Mindfulness-Based Cognitive Therapy (MBCT), a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, with both Cognitive Psycho-Education (CPE), an equally plausible cognitive treatment but without meditation, and treatment as usual (TAU). It will test whether MBCT reduces the risk of relapse in recurrently depressed patients and the incidence of suicidal symptoms in those with a history of suicidality who do relapse. It recruits participants, screens them by telephone for main inclusion and exclusion criteria and, if they are eligible, invites them to a pre-treatment session to assess eligibility in more detail. This trial allocates eligible participants at random between MBCT and TAU, CPE and TAU, and TAU alone in a ratio of 2:2:1, stratified by presence of suicidal ideation or behaviour and current anti-depressant use. We aim to recruit sufficient participants to allow for retention of 300 following attrition. We deliver both active treatments in groups meeting for two hours every week for eight weeks. We shall estimate effects on rates of relapse and suicidal symptoms over 12 months following treatment and assess clinical status immediately after treatment, and three, six, nine and twelve months thereafter.DiscussionThis will be the first trial of MBCT to investigate whether MCBT is effective in preventing relapse to depression when compared with a control psychological treatment of equal plausibility; and to explore the use of MBCT for the most severe recurrent depression--that in people who become suicidal when depressed.

Project description:BackgroundAccounting for how end users engage with technologies is imperative for designing an efficacious mobile behavioral intervention.ObjectiveThis mixed methods analysis examined the translational potential of user-centered design and basic behavioral science to inform the design of a new mobile intervention for obesity and binge eating.MethodsA total of 22 adults (7/22, 32% non-Hispanic White; 8/22, 36% male) with self-reported obesity and recurrent binge eating (≥12 episodes in 3 months) who were interested in losing weight and reducing binge eating completed a prototyping design activity over 1 week. Leveraging evidence from behavioral economics on choice architecture, participants chose treatment strategies from 20 options (aligned with treatment targets composing a theoretical model of the relation between binge eating and weight) to demonstrate which strategies and treatment targets are relevant to end users. The process by which participants selected and implemented strategies and their change in outcomes were analyzed.ResultsAlthough prompted to select one strategy, participants selected between 1 and 3 strategies, citing perceived achievability, helpfulness, or relevance as selection reasons. Over the week, all practiced a strategy at least once; 82% (18/22) struggled with implementation, and 23% (5/22) added a new strategy. Several themes emerged on successes and challenges with implementation, yielding design implications for supporting users in behavior change. In postexperiment reflections, 82% (18/22) indicated the strategy was helpful, and 86% (19/22) planned to continue use. One-week average within-subject changes in weight (-2.2 [SD -5.0] pounds) and binge eating (-1.6 [SD -1.8] episodes) indicated small clinical improvement.ConclusionsApplying user-centered design and basic behavioral science yielded design insights to incorporate personalization through user choice with guidance, which may enhance engagement with and potential efficacy of digital health interventions.

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Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression.

Publications

Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression.

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