ABSTRACT Background For older adults with care needs, evidence for the effectiveness of psychotherapy on depression is scarce. Methods In PSY-CARE, a pragmatic randomized controlled trial, N = 197 home-living older adults with depression and care needs were randomized into outpatient psychotherapy or an active control condition. Residential psychotherapists offered age-sensitive cognitive-behavioral psychotherapy (at-home if needed). Control group participants received telephone counseling and a self-help guide. Outcomes were assessed at baseline (T1), after (T2), 3 months after (T3), and 12 months after the intervention (T4). Results There was a significant decrease in depressive symptoms across both arms with Cohen’s d T4-T1 = .52 in the psychotherapy and .55 in the control group. Mixed models revealed no statistically significant difference in primary and secondary outcomes between interventions. Posthoc, we found control group participants with greater ADL limitations experienced significantly increased depressive symptoms compared to those reporting lower limitations. Conclusions Interventions were successful in reducing depressive symptoms, even though treatment fidelity was decreased due to the COVID-19 pandemic. We could not demonstrate superior effectiveness of psychotherapy for older adults with care needs. Clinical implications Findings suggest that psychotherapy may be an important and superior treatment to circumvent aggravation of depression in older patients with high functional limitations. Trial registration The trial was prospectively registered with the ISRCTN registry (Trial registration number: ISRCTN55646265, February 15, 2019).
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