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The effects of a dialogue-based intervention to promote psychosocial well-being after stroke: a randomized controlled trial.

ABSTRACT: OBJECTIVE:To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12?months post-stroke. DESIGN:Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups. SETTING:Community. SUBJECTS:Three-hundred and twenty-two adults (?18?years) with stroke within the last four weeks were randomly allocated into intervention group (n?=?166) or control group (n?=?156). INTERVENTIONS:The intervention group received a dialogue-based intervention to promote psychosocial well-being, comprising eight individual 1-1½?hour sessions delivered during the first six months post-stroke. MAIN MEASURES:The primary outcome measure was the General Health Questionnaire-28 (GHQ-28). Secondary outcome measures included the Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire. RESULTS:The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group. At 12?months post-stroke, the mean (SE) GHQ-28 score was 20.6 (0.84) in the intervention group and 19.9 (0.85) in the control group. There were no between-group differences in psychosocial well-being at 12?months post-stroke (mean difference: -0.74, 95% confidence interval (CI): -3.08, 1.60). The secondary outcomes showed no statistically significant between-group difference in health-related quality of life, sense of coherence, or depression at 12?months. CONCLUSION:The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12?months post-stroke.

SUBMITTER: Bragstad LK

PROVIDER: S-EPMC7372590 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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The effects of a dialogue-based intervention to promote psychosocial well-being after stroke: a randomized controlled trial.

Bragstad Line Kildal LK Hjelle Ellen Gabrielsen EG Zucknick Manuela M Sveen Unni U Thommessen Bente B Bronken Berit Arnesveen BA Martinsen Randi R Kitzmüller Gabriele G Mangset Margrete M Kvigne Kari Johanne KJ Hilari Katerina K Lightbody C Elizabeth CE Kirkevold Marit M

Clinical rehabilitation 20200610 8

<h4>Objective</h4>To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12 months post-stroke.<h4>Design</h4>Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups.<h4>Setting</h4>Community.<h4>Subjects</h4>Three-hundred and twenty-two adults (⩾18 years) with stroke within the last four weeks were randomly allocated into intervention group (<i>n</i> = 166) or control group (<i>n</i> = 156).<h4>Interventions</h4>The ...[more]

PMID: 32517513

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Project description:Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia.The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity.The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home.NCT02338869 ; registered 10/04/2014 (On-going trial).

Project description:BackgroundA commonly applied control condition in trials evaluating complex interventions in rehabilitation research is "usual care." The main challenge is to ensure that the control group receives genuine usual care as delivered in everyday clinical practice. The assessment interviews and dialogues with the data collectors may influence the control group participants' reflections on their condition and adjustments. This represents a threat to the internal validity of the trial. Thus, the aim of this study was to explore the perceived study-induced influence of assessment interviews on the adjustment of the members of a control group in a randomized clinical trial. The aim of the trial was to test a dialogue-based psychosocial intervention aiming at promoting the psychosocial well-being and adjustment of stroke survivors.MethodsFifteen participants in the control group of a multicenter stroke rehabilitation trial participated in narrative semi-structured interviews. Ricoeur's interpretation theory guided the analysis.ResultsThe perceived study-induced influence of the assessment interviews on the adjustment process of members of the control group varied considerably. The results demonstrated that the assessment interviews facilitated some participants' feelings of control and their ability to cope. Other participants' statements indicate that they relied on their existing personal capacity to cope and adjust and that the assessment interviews did not make any difference either on their coping ability or on their process of adjustment. Five themes were identified that described the perceived study-induced influence of the assessment interviews in the control group. The themes illustrated that the assessments served as a safety net, enhanced awareness and understanding, encouraged seeking support, allowed the opportunity to vent disappointment, or did not make any difference either way.ConclusionsRCT assessment interviews may influence the adjustment process and represent a serious problem in measuring interventions over time in trials of complex interventions in rehabilitation research. To uphold rigor and stringency, the usual care control conditions should be thoroughly assessed and described. Informing participants only about the treatment they were allocated to receive might counteract the potential to dilute the difference between the two arms of the trial.Trial registrationClinicalTrials.gov NCT02338869. Registered on October 4, 2014.

Project description:BACKGROUND:Adolescence is crucial period for laying the foundations for healthy development and mental well-being. The increasing prevalence of mental disorders amongst adolescents makes promotion of mental well-being and prevention interventions at schools important. UPRIGHT (Universal Preventive Resilience Intervention Globally implemented in schools to improve and promote mental Health for Teenagers) is designed as a whole school approach (school community, students and families) to promote a culture of mental well-being and prevent mental disorders by enhancing resilience capacities. The present article aims at describing the rationale, conceptual framework, as well as methodology of implementation and evaluation of the UPRIGHT intervention. METHODS:UPRIGHT project is a research and innovation project funded by the European Union's Horizon 2020 Research and Innovation programme under grant agreement No. 754919 (Duration: 48?months). The theoretical framework has been developed by an innovative and multidisciplinary approach using a co-creation process inside the UPRIGHT Consortium (involving seven institutions from Spain, Italy, Poland, Norway, Denmark, and Iceland). Resulted is the UPRIGHT programme with 18 skills related to 4 components: Mindfulness, Coping, Efficacy and Social and Emotional Learning. Among the five Pan-European regions, 34 schools have been currently involved (17 control; 17 intervention) and around 6000 adolescents and their families are foreseen to participate along a 3-year period of evaluation. Effectiveness of the intervention will be evaluated as a randomized controlled trial including quantitative and qualitative analysis in the five Pan-European regions representative of the cultural and socioeconomic diversity. The cost-effectiveness assessment will be performed by simulation modelling methods. DISCUSSION:We expect a short- to medium-term improvement of mental well-being in adolescents by enhancing resilience capacities. The study may provide robust evidence on intrapersonal, familiar and social environmental resilience factors promoting positive mental well-being. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03951376 . Registered 15 May 2019.

Project description:BackgroundFun For Wellness (FFW) is an online behavioral intervention developed to encourage growth in well-being by providing capability-enhancing learning opportunities to participants. Self-efficacy theory guides the conceptual model underlying the FFW intervention. Some initial evidence has been provided for the efficacy of FFW to promote: well-being self-efficacy; interpersonal, community, psychological and economic subjective well-being; and, interpersonal and physical well-being actions. The purpose of this paper is to describe the protocol for a new randomized controlled trial (RCT) designed to provide the first investigation of the effectiveness of FFW to increase well-being and physical activity in adults with obesity in the United States of America.MethodsThe study design is a large-scale, prospective, parallel group RCT. Approximately 9 hundred participants will be randomly assigned to the FFW or Usual Care (UC) group to achieve a 1:1 group (i.e., ffwUC) assignment. Participants will be recruited through an online panel recruitment company. Data collection, including determination of eligibility, will be conducted online and enrollment is scheduled to begin on 8 August 2018. Data collection will occur at baseline, 30 days and 60 days after baseline. Instruments to measure demographic information, anthropometric characteristics, self-efficacy, physical activity and well-being will be included in the battery. Data will be modeled under an intent to treat approach and/or a complier average causal effect approach depending on the level of observed engagement with the intervention.DiscussionThe effectiveness trial described in this paper builds upon the 2015 FFW efficacy trial and has the potential to be important for at least three reasons. The first reason is based upon a general scientific approach that the potential utility of interventions should be evaluated under both ideal (e.g., more controlled) and real-world (e.g., less controlled) conditions. The second reason is based upon the global need for readily scalable online behavioral interventions that effectively promote physical activity in adults. The third reason is based upon the troubling global trend toward obesity along with evidence for obesity as a risk factor for several major non-communicable diseases.Trial registrationClinicalTrials.gov, identifier: NCT03194854 , registered 21 June 2017.

Project description:BackgroundMedical professionals are exposed to multiple and often excessive demands in their work environment. Low-intensity internet interventions allow them to benefit from psychological support even when institutional help is not available. Focusing on enhancing psychological resources-self-efficacy and perceived social support-makes an intervention relevant for various occupations within the medical profession. Previously, these resources were found to operate both individually or sequentially with self-efficacy either preceding social support (cultivation process) or following it (enabling process).ObjectiveThe objective of this randomized controlled trial is to compare the efficacy of 4 variants of Med-Stress, a self-guided internet intervention that aims to improve the multifaceted well-being of medical professionals.MethodsThis study was conducted before the COVID-19 pandemic. Participants (N=1240) were recruited mainly via media campaigns and social media targeted ads. They were assigned to 1 of the following 4 groups: experimental condition reflecting the cultivation process, experimental condition reflecting the enabling process, active comparator enhancing only self-efficacy, and active comparator enhancing only perceived social support. Outcomes included 5 facets of well-being: job stress, job burnout, work engagement, depression, and job-related traumatic stress. Measurements were taken on the web at baseline (time 1), immediately after intervention (time 2), and at a 6-month follow-up (time 3). To analyze the data, linear mixed effects models were used on the intention-to-treat sample. The trial was partially blinded as the information about the duration of the trial, which was different for experimental and control conditions, was public.ResultsAt time 2, job stress was lower in the condition reflecting the cultivation process than in the one enhancing social support only (d=-0.21), and at time 3, participants in that experimental condition reported the lowest job stress when compared with all 3 remaining study groups (ds between -0.24 and -0.41). For job-related traumatic stress, we found a significant difference between study groups only at time 3: stress was lower in the experimental condition in which self-efficacy was enhanced first than in the active comparator enhancing solely social support (d=-0.24). The same result was found for work engagement (d=-0.20), which means that it was lower in exactly the same condition that was found beneficial for stress relief. There were no differences between study conditions for burnout and depression neither at time 2 nor at time 3. There was a high dropout in the study (1023/1240, 82.50% at posttest), reflecting the pragmatic nature of this trial.ConclusionsThe Med-Stress internet intervention improves some components of well-being-most notably job stress-when activities are completed in a specific sequence. The decrease in work engagement could support the notion of dark side of this phenomenon, but further research is needed.Trial registrationClinicalTrials.gov NCT03475290; https://clinicaltrials.gov/ct2/show/NCT03475290.International registered report identifier (irrid)RR2-10.1186/s13063-019-3401-9.

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.

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The effects of a dialogue-based intervention to promote psychosocial well-being after stroke: a randomized controlled trial.

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The effects of a dialogue-based intervention to promote psychosocial well-being after stroke: a randomized controlled trial.

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