Dataset Information

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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Publications

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:BackgroundStroke 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.MethodsThe 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.DiscussionThe 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.Trial registrationNCT02338869 ; 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:ObjectivesWe aimed to evaluate the feasibility and effectiveness of a brief community-based intervention to promote physical activity (PA) and the mental well-being of adults in Hong Kong.MethodsA pilot cluster randomized controlled trial was conducted in 15 family service centers. The intervention group (N = 162, 8 centers) received two 2-h interventions uniquely combining "Sharing, Mind and Enjoyment (SME)," Zero-time Exercises (ZTEx), positive psychology, and simple family games. "Sharing" involved promoting PA among families and peers, "Mind" captured positive emotions during PA, and "Enjoyment" assessed engagement of PA. ZTEx are simple PAs to reduce sedentary behaviors and enhancing PA and fitness and require minimal time and no cost or equipment. The control group (N = 152, 7 centers) received interventions unrelated to SME. Primary outcomes were PA-related SME at a 3-month follow-up after completing the baseline questionnaire. Secondary outcomes included subjective happiness, well-being, and family-related outcomes. Participants reported self-perceived changes at 1- and 3-month. Nine focus group discussions with the participants and 4 individual in-depth interviews with community service providers were conducted.ResultsThe retention rate at1 month was 90.1% for the intervention group and 95.4% for the control group, while at 3 months, it was 83.3% and 92.8%, respectively. The intervention group showed significantly greater positive changes in PA-related outcomes than the control group at 3-month follow-up (Cohen's d = 0.33-0.42, all P < .05). Most secondary outcomes were non-significantly different between the 2 groups. However, more than 90% of participants in the intervention group reported self-perceived positive changes at 1- and 3-month follow-ups. The qualitative data showed that ZTEx was popular with families due to its simplicity.ConclusionsOur trial showed the feasibility of implementing the brief interventions and the potential benefits for promoting physical activity in community adults.Clinicaltrials.gov identifierNCT03332810 (date of registration: November 6, 2017).

Project description:IntroductionStress at work and psychosocial risks are a major public health problem. Sophrology and neurolinguistic programming (NLP) have demonstrated benefits in terms of mental, physical and social health, both in the general population and in patients, and both in and out of hospital settings. However, these approaches have never been provided at the hospital for the benefit of health professionals at risk of suffering at work. In general, we aim to demonstrate the effectiveness of a hospital sophrology/NLP intervention for health care professionals at risk of stress-related disorders. The secondary objectives are to study (i) within-group, and (ii) between-group): (1) effects on mental, physical, and social health; (2) persistence of effect; (3) relationships between job perception and mental, physical, and social health; (4) intervention success factors (personality and job perception, attendance and practice, other); (5) effects on other stress biomarkers (other measures of autonomic nervous system activity, DHEAS, cortisol, etc.).MethodsOur study will be a randomized controlled prospective study (research involving the human person of type 2). The study will be proposed to any health-care workers (HCW) or any non-HCW (NHCW) from a healthcare institution (such as CHU of Clermont-Ferrand, other hospitals, clinics, retirement homes). Participants will benefit from NLP and sophrology interventions at the hospital. For both groups: (i) heart rate variability, skin conductance and saliva biomarkers will be assessed once a week during the intervention period (6 to 8 sophrology sessions) and once by month for the rest of the time; (ii) the short questionnaire will be collected once a week during the whole protocol (1-2 min); (iii) the long questionnaire will be assessed only 5 times: at baseline (M0), month 1 (M1), month 3 (M3), month 5 (M5) and end of the protocol (M7).Ethics and disseminationThe protocol, information and consent form had received the favorable opinion from the Ethics Committee. Notification of the approval of the Ethics Committee was sent to the study sponsor and the competent authority (ANSM). The study is registered in ClinicalTrials.gov under the identification number NCT05425511 after the French Ethics Committee's approval. The results will be reported according to the CONSORT guidelines.Strengths and limitations of this studyThe psychological questionnaires in this study are self-assessed. It is also possible that responses suffer from variation. For the study, participants need to attend 6 to 8 sophrology sessions and one visit per month for 7 months, which might seem demanding. Therefore, to make sure that participants will complete the protocol, two persons will be fully in charge of the participants' follow-up.

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:BackgroundAdolescence 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.MethodsUPRIGHT 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.DiscussionWe 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 registrationClinicalTrials.gov Identifier: NCT03951376 . Registered 15 May 2019.

Dataset Information

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

Objective

Design

Setting

Subjects

Interventions

Main measures

Results

Conclusion

Publications

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

Similar Datasets

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