Outpatient psychotherapy for home-living vulnerable older adults with depression: study protocol of the PSY-CARE trial

BACKGROUND: There is a need to improve psychotherapeutic approaches to treatment for vulnerable older adults with depression in terms of both clinical practice and health care supply. Against this background, PSY-CARE is testing the feasibility and effectiveness of outpatient psychotherapy for home-living older adults in need of care with depression in Berlin, Germany, and neighboring suburban areas. METHODS: In a two-arm single-center pragmatic randomized controlled trial (RCT), manual-guided outpatient psychotherapy will be compared to brief psychosocial counseling. The study population will be compromised of older adults with clinically significant depressive symptoms who have a long-term care grade, as assessed by the German compulsory state nursing care insurance. In the intervention group, individual cognitive-behavioral psychotherapy tailored to the specific needs of this population will be offered by residential psychotherapists as part of the regular healthcare service. In the active control group, participants will receive individual psychosocial telephone counselling and a self-help guide. The planned sample size is N = 130 (n = 65 participants per group). The reduction of depressive symptoms (primary outcome) as well as the maintaining of activities of daily living, quality of life, and functioning will be assessed with questionnaires provided at baseline, after the end of the intervention and after three months. Feasibility and process evaluation will be conducted qualitatively based on documentation and interviews with psychotherapists, gatekeepers and the participants. DISCUSSION: PSY-CARE investigates the potentials and limitations of providing outpatient psychotherapeutic treatment meeting the demands of vulnerable home-living older adults with depression under the real conditions of the health care system. The study will provide practical implications to improve access to and quality of outpatient psychotherapy for this poorly supplied population. TRIAL REGISTRATION: The trial is registered at ISRCTN55646265; February 15, 2019. SUPPLEMENTARY INFORMATION: Supplementary information accompanies this paper at 10.1186/s12877-020-01661-1.