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      A randomized controlled trial of a targeted support program for informal caregivers in adult psychiatry

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          Abstract

          Background

          The importance of informal caregivers for persons with severe mental illness has been demonstrated. However, this role may cause a high care burden that considerably affects caregiver health. The Ensemble program is a five-session brief individual intervention designed to support informal caregivers. This trial aimed to assess the efficacy of the program versus SAU (support as usual) for participants with a high care burden.

          Methods

          A single-center randomized controlled trial including 149 participants was conducted. Caregivers in the intervention arm participated in the Ensemble program. The effects of the intervention were assessed using mixed models for repeated measures analysis of variance on improvements in informal caregivers’ psychological health status, optimism levels, burden scores, and quality of life at three time points (T0 = pretest; T1 = posttest at 2 months, and T2 = follow-up at 4 months).

          Results

          Analysis of the Global Psychological Index showed no significant effect at the two endpoints in favor of the Ensemble group. However, the Brief Symptom Inventory-Positive Symptom Distress Index was significantly lower at the two-month follow-up. A significant reduction in burden on the Zarit Burden Interview was observed post-intervention, along with an increase in optimism levels on the Life Orientation Test-Revised at follow-up in the Ensemble group. No significant differences were observed in quality of life. Clinical improvements in both psychological health status and burden levels were also identified.

          Conclusion

          The Ensemble program offers an inclusive approach based on a recovery perspective that significantly reduces symptom distress and burden and increases optimism among informal caregivers.

          Clinical trial registration: https://clinicaltrials.gov/, NCT04020497.

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          Most cited references38

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          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Paul A. Harris, Robert Taylor, Robert Thielke … (2009)
          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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            The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection.

            J E Ware, C Sherbourne (1992)
            A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
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              Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test.

              Michael F Scheier, Charles S. Carver, Michael W. Bridges (1994)
              Research on dispositional optimism as assessed by the Life Orientation Test (Scheier & Carver, 1985) has been challenged on the grounds that effects attributed to optimism are indistinguishable from those of unmeasured third variables, most notably, neuroticism. Data from 4,309 subjects show that associations between optimism and both depression and aspects of coping remain significant even when the effects of neuroticism, as well as the effects of trait anxiety, self-mastery, and self-esteem, are statistically controlled. Thus, the Life Orientation Test does appear to possess adequate predictive and discriminant validity. Examination of the scale on somewhat different grounds, however, does suggest that future applications can benefit from its revision. Thus, we also describe a minor modification to the Life Orientation Test, along with data bearing on the revised scale's psychometric properties.
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                Author and article information

                Contributors
                Shyhrete Rexhaj: URI : https://loop.frontiersin.org/people/453503/overviewRole: Role: Role: Role: Role: Role: Role: Role: Role: Role: Role: Role:
                Debora Martinez: URI : https://loop.frontiersin.org/people/2122933/overviewRole: Role: Role: Role: Role: Role: Role:
                Philippe Golay: URI : https://loop.frontiersin.org/people/48411/overviewRole: Role: Role: Role: Role:
                Claire Coloni-Terrapon: Role: Role: Role: Role:
                Shadya Monteiro: Role: Role: Role:
                Leslie Buisson: Role: Role: Role:
                Anne-Laure Drainville: URI : https://loop.frontiersin.org/people/1685357/overviewRole: Role: Role:
                Charles Bonsack: Role: Role:
                Alban Ismailaj: Role: Role: Role:
                Alexandra Nguyen: Role: Role: Role:
                Jérôme Favrod: URI : https://loop.frontiersin.org/people/134386/overviewRole: Role: Role: Role: Role: Role: Role: Role:
                Journal
                Journal ID (nlm-ta): Front Psychiatry
                Journal ID (iso-abbrev): Front Psychiatry
                Journal ID (publisher-id): Front. Psychiatry
                Title: Frontiers in Psychiatry
                Publisher: Frontiers Media S.A.
                ISSN (Electronic): 1664-0640
                Publication date (Electronic): 30 November 2023
                Publication date Collection: 2023
                Volume: 14
                Electronic Location Identifier: 1284096
                Affiliations
                [1] 1La Source, School of Nursing Sciences, HES-SO University of Applied Sciences , Lausanne, Switzerland
                [2] 2Community Psychiatry Service, Department of Psychiatry, University Hospital, CHUV, University of Lausanne , Lausanne, Switzerland
                [3] 3Institute of Psychology, Faculty of Social and Political Science, University of Lausanne , Lausanne, Switzerland
                [4] 4SISP SA , Lausanne, Switzerland
                Author notes

                Edited by: Antonio Vita, University of Brescia, Italy

                Reviewed by: Silvio Bellino, University of Turin, Italy; Alberto Stefana, University of Pavia, Italy

                *Correspondence: Shyhrete Rexhaj, s.rexhaj@ 123456ecolelasource.ch
                Article
                DOI: 10.3389/fpsyt.2023.1284096
                PMC ID: 10719931
                PubMed ID: 38098635
                SO-VID: 3539d5cb-de0b-4f03-9630-cc7c4586ed6d
                Copyright © Copyright © 2023 Rexhaj, Martinez, Golay, Coloni-Terrapon, Monteiro, Buisson, Drainville, Bonsack, Ismailaj, Nguyen and Favrod.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                Date received : 11 September 2023
                Date accepted : 14 November 2023
                Page count
                Figures: 2, Tables: 3, Equations: 0, References: 38, Pages: 11, Words: 6870
                Funding
                The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study was supported by the Swiss National Science Foundation, grant number 10001C_185422.
                Categories
                Subject: Psychiatry
                Subject: Original Research
                Custom metadata
                section-at-acceptance Psychological Therapy and Psychosomatics

                ScienceOpen disciplines: Clinical Psychology & Psychiatry
                Keywords: informal caregivers,mental health,randomized controlled trial,individual intervention,burden,painful emotions
                Data availability:
                ScienceOpen disciplines: Clinical Psychology & Psychiatry
                Keywords: informal caregivers, mental health, randomized controlled trial, individual intervention, burden, painful emotions

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