PMID- 29615136 OWN - NLM STAT- MEDLINE DCOM- 20180813 LR - 20220408 IS - 2050-7283 (Electronic) IS - 2050-7283 (Linking) VI - 6 IP - 1 DP - 2018 Apr 3 TI - Promoting psychosocial well-being following stroke: study protocol for a randomized, controlled trial. PG - 12 LID - 10.1186/s40359-018-0223-6 [doi] LID - 12 AB - BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: NCT02338869 ; registered 10/04/2014 (On-going trial). FAU - Kirkevold, Marit AU - Kirkevold M AUID- ORCID: 0000-0002-3979-0631 AD - Institute of Health and Society and Research Center for habilitation and rehabilitation services and models (CHARM), University of Oslo, P.O.Box 1130, Blindern, 0318, Oslo, Norway. marit.kirkevold@medisin.uio.no. FAU - Kildal Bragstad, Line AU - Kildal Bragstad L AD - Institute of Health and Society and Research Center for habilitation and rehabilitation services and models (CHARM), University of Oslo, P.O.Box 1130, Blindern, 0318, Oslo, Norway. FAU - Bronken, Berit A AU - Bronken BA AD - Inland Norway University of Applied Sciences, P.O.Box 400, 2418, Elverum, Norway. FAU - Kvigne, Kari AU - Kvigne K AD - Inland Norway University of Applied Sciences, P.O.Box 400, 2418, Elverum, Norway. FAU - Martinsen, Randi AU - Martinsen R AD - Inland Norway University of Applied Sciences, P.O.Box 400, 2418, Elverum, Norway. FAU - Gabrielsen Hjelle, Ellen AU - Gabrielsen Hjelle E AD - Institute of Health and Society and Research Center for habilitation and rehabilitation services and models (CHARM), University of Oslo, P.O.Box 1130, Blindern, 0318, Oslo, Norway. FAU - Kitzmuller, Gabriele AU - Kitzmuller G AD - Faculty of Health UIT, The Arctic University of Norway, Campus, Narvik, Norway. FAU - Mangset, Margrete AU - Mangset M AD - Department of Geriatric Medicine, Oslo University Hospital, P.O box 4956, Nydalen, 0424, Oslo, Norway. FAU - Angel, Sanne AU - Angel S AD - Institute of Public Health, Aarhus University, Hoegh-Guldbergs Gade 6 A, 8000, Aarhus, Denmark. FAU - Aadal, Lena AU - Aadal L AD - Hammel Neurorehabilitation and Research Centre, Voldbyvej 15 8450, Hammel, Denmark. FAU - Eriksen, Siren AU - Eriksen S AD - Norwegian National Advisory Unit on Ageing and Health (Ageing and Health), P. O. Box 2136, 3103, Tonsberg, Norway. FAU - Wyller, Torgeir B AU - Wyller TB AD - Institute of Clinical Medicine, University of Oslo, and Department. of Geriatric Medicine, Oslo University Hospital, P.O box 4956 Nydalen, 0424, Oslo, Norway. FAU - Sveen, Unni AU - Sveen U AD - Dept. of Geriatric Medicine, and Dept. of Physical Medicine and Rehabilitation, Oslo University Hospital, P.O box 4956 Nydalen, 0424, Oslo, Norway. LA - eng SI - ClinicalTrials.gov/NCT02338869 GR - 2013086/Helse Sor-Ost RHF/ GR - 2015/FO13753/EkstraStiftelsen Helse og Rehabilitering/ GR - 609020/FP7-PEOPLE-2013-COFUND/ PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20180403 PL - England TA - BMC Psychol JT - BMC psychology JID - 101627676 SB - IM MH - Adult MH - Anxiety/etiology/*therapy MH - Depression/etiology/*therapy MH - Female MH - Humans MH - Male MH - Outcome Assessment, Health Care/*methods MH - Psychotherapy/*methods MH - Quality of Life/*psychology MH - Single-Blind Method MH - Stroke/complications/*psychology PMC - PMC5883408 OTO - NOTNLM OT - Aphasia OT - Dialogue-based OT - Implementation adherence OT - Intervention fidelity OT - Process evaluation OT - Psychosocial rehabilitation OT - Randomized controlled trial OT - Stroke OT - Supportive care COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The study has been approved by the Regional Medical Ethics Committee (REK) (2013/2047) and the Patient Ombudsman (2014/1026) responsible for the collaborating hospital centers recruiting to the study. Written informed consent, adjusted to stroke survivors with aphasia [78], is collected from the participants. The study follows the guidelines of the Helsinki declaration. CONSENT FOR PUBLICATION: The written consent form contains information about scientific publication of results of study in anonymous form. COMPETING INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/04/05 06:00 MHDA- 2018/08/14 06:00 PMCR- 2018/04/03 CRDT- 2018/04/05 06:00 PHST- 2017/10/08 00:00 [received] PHST- 2018/03/11 00:00 [accepted] PHST- 2018/04/05 06:00 [entrez] PHST- 2018/04/05 06:00 [pubmed] PHST- 2018/08/14 06:00 [medline] PHST- 2018/04/03 00:00 [pmc-release] AID - 10.1186/s40359-018-0223-6 [pii] AID - 223 [pii] AID - 10.1186/s40359-018-0223-6 [doi] PST - epublish SO - BMC Psychol. 2018 Apr 3;6(1):12. doi: 10.1186/s40359-018-0223-6.