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Promoting psychosocial wellbeing following stroke using narratives and guided self-determination: a feasibility study.

ABSTRACT: Extensive studies have documented the complex and comprehensive psychosocial consequences of stroke. Psychosocial difficulties significantly affect long-term functioning and quality of life. Many studies have explored psychosocial interventions to prevent or treat psychosocial problems, but most have found modest effects. This study evaluated, from the perspective of adult stroke survivors, (1) the content, structure and process and (2) experienced usefulness of a dialogue-based psychosocial nursing intervention in primary care aimed at promoting psychosocial health and wellbeing.This was part of a feasibility study guided by the UK MRC complex interventions framework. It consisted of dialogue-based encounters with trained health professionals during approximately the first year poststroke. It was tested in two formats; individual or group encounters. Inclusion criteria were: Acute stroke, above 18 y.o., sufficient physical and cognitive functioning to participate. Data were collected immediately before, during and 14 days after the completion of the intervention. Pre- and post-data included medical and demographic data, quality of life, emotional wellbeing, life satisfaction, anxiety and depression. Qualitative interviews focusing on participant experiences were conducted two weeks following the intervention. Log notes taken by the health professionals conducting the intervention and work sheets filled in by participants also comprised data. Data analysis was case-oriented. The structured instruments were analysed regarding completeness of data and indication of changes in outcome variables. The qualitative interviews, log notes and work sheets were analysed using thematic content analysis.Twenty-five stroke survivors (17 men, 8 women), median age 64 (range 33-89), participated. Physical limitations varied from mild to severe. Seven participants had moderate to severe expressive aphasia. The participants found the content and process of the intervention relevant. Both the individual and group formats were found useful. Patients with aphasia reported that there were too few encounters (eight encounters were originally planned). The participants underscored the benefits of being supported through a difficult time, having a chance to tell and (re)create their story and being supported in their attempts to cope with the situation.This study provides initial support for the usefulness of the psychosocial intervention and highlights areas requiring further consideration and development.ClinicalTrials.gov Identifier: NCT01912014.

SUBMITTER: Kirkevold M

PROVIDER: S-EPMC4270047 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Promoting psychosocial wellbeing following stroke using narratives and guided self-determination: a feasibility study.

Kirkevold Marit M Martinsen Randi R Bronken Berit Arnesveen BA Kvigne Kari K

BMC psychology 20140203 1

<h4>Background</h4>Extensive studies have documented the complex and comprehensive psychosocial consequences of stroke. Psychosocial difficulties significantly affect long-term functioning and quality of life. Many studies have explored psychosocial interventions to prevent or treat psychosocial problems, but most have found modest effects. This study evaluated, from the perspective of adult stroke survivors, (1) the content, structure and process and (2) experienced usefulness of a dialogue-bas ...[more]

PMID: 25566379

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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: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:INTRODUCTION:The aftermath of stroke leaves many consequences including cognitive deficits and falls due to imbalance. Stroke survivors and families struggle to navigate the complex healthcare system with little assistance posthospital discharge, often leading to early hospital readmission and worse stroke outcomes. Telemedicine Guided Education on Secondary Stroke and Fall Prevention Following Inpatient Rehabilitation feasibility study examines whether stroke survivors and their caregivers find value in telerehabilitation (TR) home visits that provide individualised care and education by a multidisciplinary team after discharge from inpatient rehabilitation. METHODS AND ANALYSIS:A prospective, single arm, pilot study is designed to evaluate the feasibility of weekly TR home visits initiated postdischarge from inpatient rehabilitation. Newly diagnosed patients with stroke are recruited from a Houston-based comprehensive stroke centre inpatient rehabilitation unit, loaned an iPad with data plan and trained to use information technology security-approved videoconferencing application. After hospital discharge, six weekly TR home visits are led by rotating specialists (pharmacist, physical/occupational therapist, speech therapist, rehabilitation physician, social worker, geriatrician specialised in fracture prevention) followed by satisfaction survey on week 7. Specialists visually assess patients in real time, educate them on secondary stroke and fall prevention and suggest ways to improve function including direct medical interventions when indicated. Primary outcomes are proportion of eligible patients consenting to the study, participation rate in all six TR home visits and satisfaction score. The study started 31 December 2015 with plan to enrol up to 50 patients over 24 months. Feasibility study results will inform us as to whether a randomised controlled trial is warranted to determine efficacy of TR home visit intervention in improving stroke outcomes. ETHICS AND DISSEMINATION:Ethics approval obtained by the Institutional Review Board (IRB), Committee for the Protection of Human Subjects, IRB number: HSC-MS-14-0994. Study results will be submitted for publication in a peer-reviewed journal.

Project description:BackgroundStroke in adults aged between 18 and 64?years old is increasing significantly worldwide. Studies have reported that this group of young stroke survivors encounters enormous difficulties reintegrating into their social roles. Individualised discussions with healthcare professionals and learning from other survivors are imperative for them to reconstruct their identities after stroke. There is also great demand for community support during their chronic stage of recovery to help them rebuild life skills to promote reintegration.Methods/designThis is a randomised controlled trial to investigate the effects of a 24-week Narrative and Skills-building Intervention (NSI) on young stroke survivors' community reintegration and psychosocial outcomes. A total of 208 adults aged 18-64?years old with a first-ever or recurrent ischaemic or haemorrhagic stroke and have been discharged home will be recruited and randomly assigned to receive usual care or usual care with NSI. The NSI is grounded in Narrative Theory and Bandura's principles of Self-efficacy and Outcome Expectation, consisting of successive eight individual sessions over six months delivered by a trained facilitator (a registered nurse). Participants will be facilitated to narrate their survival experiences and rebuild core life skills. Videos of peer young stroke survivors' experiences of recovery will be provided. Outcomes including community reintegration, depressive symptoms, health-related quality of life, self-efficacy, outcome expectation and satisfaction with performance of self-management behaviours will be measured before (T0) and immediately after NSI (T1), then six (T2) and 12?months after NSI (T3). Generalised estimating equations models will be used to compare the differential changes in outcomes across time between the two groups. Focus group interviews will be conducted with the facilitator at T1 and with the participants in the intervention group at T1 and T3.DiscussionThis study will evaluate the short and long-term effects of a theory-based NSI on young stroke survivors' community reintegration and establish a new model of community reintegration after stroke to inform future research. The results will also provide valuable evidence to develop clinical guidelines for young stroke survivors' community reintegration.Trial registrationClinicalTrials.gov identifier: NCT04560140 , registered on 23 September, 2020.

Project description:ObjectiveAccess to effective treatments for adolescents with depression needs to improve. Few studies have evaluated behavioural activation (BA) for adolescent depression, and none remotely delivered BA. This study explored the feasibility and acceptability of therapist-guided and self-guided internet-delivered BA (I-BA) in preparation for a future randomised controlled trial (RCT).DesignA single-blinded randomised controlled feasibility trial.SettingA specialist outpatient clinic in Sweden.ParticipantsThirty-two adolescents with mild-to-moderate major depression, aged 13-17 years.InterventionsTen weeks of therapist-guided I-BA or self-guided I-BA, or treatment as usual (TAU). Both versions of I-BA included parental support. TAU included referral to usual care within child and youth psychiatry or primary care.OutcomesFeasibility measures included study take-up, participant retention, acceptability, safety and satisfaction. The primary outcome measure was the blinded assessor-rated Children's Depression Rating Scale, Revised. The primary endpoint was the 3-month follow-up.Results154 adolescents were screened and 32 were randomised to therapist-guided I-BA (n=11), self-guided I-BA (n=10) or TAU (n=11). Participant retention was acceptable, with two drop-outs in TAU. Most participants in TAU had been offered interventions by the primary endpoint. The mean number of completed chapters (total of 8) for adolescents was 7.5 in therapist-guided I-BA and 5.4 in self-guided I-BA. No serious adverse events were recorded. Satisfaction was acceptable in both I-BA groups. Following an intent-to-treat approach, the linear mixed-effects model revealed that both therapist-guided and self-guided I-BA (Cohen's d=2.43 and 2.23, respectively), but not TAU (Cohen's d=0.95), showed statistically significant changes on the primary outcome measure with large within-group effect sizes.ConclusionsBoth therapist-guided and self-guided I-BA are acceptable and potentially efficacious treatments for adolescents with depression. It is feasible to conduct a large-scale RCT to establish the efficacy and cost-effectiveness of I-BA versus TAU.Trial registration numberClinicalTrials.gov Registry (NCT04117789).

Project description:BackgroundDepression in adolescents is a large and growing problem; however, access to effective mental health care continues to be a challenge. Digitally based interventions may serve to bridge this access gap for adolescents in need of care. Digital interventions that deliver components of cognitive behavioral therapy (CBT) have been shown to reduce symptoms of depression, and virtual reality (VR) may be a promising adjunctive component. However, research on these types of treatments in adolescents and young adults is limited.ObjectiveThis study aims to evaluate the feasibility, acceptability, and preliminary efficacy of Spark (v1.0), a 5-week, self-guided, CBT-based digital program using a mobile app and VR experiences to target symptoms of depression in adolescents.MethodsA single-arm, open-label study of the Spark program was conducted with a community sample of 30 adolescents and young adults aged 12 to 21 years with self-reported moderate to severe depression symptoms. Participants completed a weekly depression assessment (Patient Health Questionnaire-8) in the app during the 5-week intervention period as well as web-based baseline, postintervention, and 1-month follow-up self-report assessments. The participants also completed a qualitative postintervention interview. For participants aged <18 years, caregivers completed assessments at baseline and postintervention time points. Feasibility outcomes included recruitment rate (the proportion of participants who enrolled in the study divided by the total number of participants screened for eligibility) and retention rate (the proportion of participants who completed postintervention assessments divided by the total number of participants who received the intervention). Acceptability outcomes included engagement with the program and quantitative and qualitative feedback about the program. Preliminary efficacy was evaluated based on the Patient Health Questionnaire-8.ResultsThe study recruitment (31/66, 47%) and retention (29/30, 97%) rates were high. Participants provided higher ratings for the ease of use of the Spark program (8.76 out of 10) and their enjoyment of both the mobile app (7.00 out of 10) and VR components (7.48 out of 10) of the program, whereas they provided lower ratings for the program's ability to improve mood (4.38 out of 10) or fit into their daily routines (5.69 out of 10). We observed a clinically and statistically significant reduction in depression scores at postintervention (mean difference 5.36; P<.001) and 1-month follow-up (mean difference 6.44; P<.001) time points.ConclusionsThe Spark program was found to be a feasible and acceptable way to deliver a self-guided CBT-focused intervention to adolescents and young adults with symptoms of depression. Preliminary data also indicated that the Spark program reduced the symptoms of depression in adolescents and young adults. Future studies should evaluate the efficacy of this intervention in an adequately powered randomized controlled trial.Trial registrationClinicalTrials.gov NCT04165681; https://classic.clinicaltrials.gov/ct2/show/NCT04165681.

Dataset Information

Promoting psychosocial wellbeing following stroke using narratives and guided self-determination: a feasibility study.

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Promoting psychosocial wellbeing following stroke using narratives and guided self-determination: a feasibility study.

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