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.


Intervention conditions
In the active control condition, in addition to the two planned contacts, we provided a third contact 2-4 days after the assessment via telephone since July 30, 2019. This phone call was made to buffer some of the insecurities related with the COVID-19 situation and aimed to motivate enrolled participants of the control condition to further participate in the study. In the intervention condition, starting from March 2020, we fostered the switch to telehealth treatment (video/ telephone) in case that face-to-face psychotherapy with protective measures could not be realized with an individual patient (e.g., therapist or patient with non-specific flu symptoms; patients with massive fear of Covid-19 infection).
Due tophysical, social and psychological challenges in the life of the participants, treatment integrity cannot be fully ensured both in the intervention as well as in the control condition. For example, it has often occurred that psychotherapists had to respond immediately to cases of acute crisis.

Assessment and data collection
Due to the COVID-19 measures, since March 16 we changed face-to-face assessments to telephone assessment (T1, T2, T3). This also included that the assessment of therapy goals between participants and psychotherapists was done via telephone. In addition to the planned assessments, we added items with regard to worries about COVID-19 infection (adapted from [4]). In order to capture the refection on the COVID-19 threat, qualitative interviews of the participants on their experience and their coping with the COVID-19 pandemic were conducted. Finally, a brief 12-month follow up (T4) will be implemented, which will focus on the primary outcome (Shortform of the Geriatric Depression Scale [5]) as well as questions regarding health and healthcare status.

Exclusion criteria
Regarding exclusion criteria, the clarification of dementia by telephone before time 1 (T1) was slightly adjusted since June 16, 2020. Since not all Mini-Mental-State-Examination (MMSE) items can be carried out via telephone, in those individuals with unclear MMSE values, we added the Six Item Cognitive Impairment Test (6-CIT [3]).

Recruitment and sample size
In the context of the first lockdown (since March, 13), we had to stop the recruitment two weeks earlier than originally planned. From March 16, no new admissions have been made; however, those participants who were already enrolled were kept in the trial. A total of N = 197 participants were included in the study and randomly assigned to the control or intervention condition. This sample size in post-hoc power analyzes (assumptions: effect d = .50; alpha = .05 one-sided; test family: t-test for independent samples) resulted in a power of 1-beta = .97 at the baseline. This does not yet take into account a dropout in the course of the study. Taking into account a dropout rate of 20%, as was the case in the a priori power analysis, a power of 1-beta = .80 would still be guaranteed. In addition, statistical measures for dealing with dropouts in the course of the study (i.e., multiple imputation) will be applied in order to maximize the informative value of the data.

Updated ethical approval
We submitted an amendment to the local ethics committee of the Medical School Berlin/ Medical School Hamburg on April 27, 2020, which covered the abovementioned corona-related changes. The amendment was approved on June 2, 2020 (Ref.: MSB-2020/33).