PSY-CARE: Psychological counselling and therapy for treating depression in homebound older adults
| ISRCTN | ISRCTN55646265 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55646265 |
| Secondary identifying numbers | 01VSF17048 |
- Submission date
- 01/02/2019
- Registration date
- 14/02/2019
- Last edited
- 22/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Older homebound people represent a significant and rapidly growing group of patients in which depression is a common health problem. However, the reality of care for this population is currently deficient. Therefore, PSY-CARE is testing the feasibility and effectiveness of outpatient short-term psychological counselling and therapy.
Who can participate?
Older home care patients (men and women) with depression aged 60 years and older.
What does the study involve?
Patients included in the study will be randomized to one of two treatment arms. One half will receive short-term psychotherapy (intervention condition), the other half will receive a self-help intervention for the patient as well as a training session for the caregiver (active control condition). The effectiveness of both conditions will be compared.
What are the possible benefits and risks of participating?
The project sheds more light on the potential and limitations of providing care for older adults receiving home care with depression, within the regular health care system. Participants benefit from treatment (short-term psychotherapy or psychoeducation training) of their depression. During the treatment, there can be a temporal deterioration in mood, which is a part of the therapeutic process and can be averted by the psychotherapist or the psychoeducation training.
Where is the study run from?
MSB Medical School Berlin, Calandrellistraße 1-9, Berlin, Germany, 12247 (lead centre); Charité – Universitätsmedizin Berlin, Charitéplatz 1, Berlin, Germany, 10117
When is the study starting and how long is it expected to run for?
June 2018 – May 2021
Who is funding the study?
German Innovation Fund of the German Federal Joint Committee (G-BA)
Who is the main contact?
Prof. Dr. Eva-Marie Kessler, eva-marie.kessler@medicalschool-berlin.de
Contact information
Scientific
Nicolaistraße 14
Berlin
12247
Germany
 ORCID ID |
0000-0001-9183-4243 |
|---|---|
| Phone | 004930 7668375 832 |
| eva-marie.kessler@medicalschool-berlin.de |
Study information
| Study design | Single-centre interventional study, using a pragmatic randomized controlled design. Participants will be blinded to their group allocation for the duration of the study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | PSY-CARE: Depression in homebound older adults – Short-term psychotherapy in healthcare teams |
| Study acronym | PSY-CARE |
| Study objectives | Primary Hypothesis: Short-term psychotherapy leads to a greater reduction of depressive symptoms, compared to the alternative psychosocial offer. Secondary Hypothesis: Short-term psychotherapy leads to a greater increase of quality of life, activities of daily living, functioning and subjective health, compared to the alternative psychosocial offer. |
| Ethics approval(s) | Approved 25/09/2018, ethics committee of the Medical School Hamburg (Geschäftsstelle der Ethikkommission, Medical School Hamburg, Am Kaiserkai 1, 20457, Hamburg; +4940 3612264-77; Ethikkommission@medicalschool-hamburg.de), ref: MSB-2018/20 |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | Patients included in the PSY-CARE study will be randomised to one of the two treatment arms. The first arm comprises short-term psychotherapy (population-appropriate augmented behavioural therapy; intervention condition) comprising of up to 24 therapy sessions and will be conducted by gerontologically qualified psychotherapists. The second arm is a short psychoeducation training for the patient as well as the caregiver (control condition), which includes self-help literature and a short individual training for recognizing and dealing with depression under the condition of home care. |
| Intervention type | Behavioural |
| Primary outcome measure | Reduction of depressive symptoms measured by self-report, including the Geriatric Depression Scale at baseline (T1), directly after the intervention (T2), as well as at follow-up after 3 months (T3). |
| Secondary outcome measures | 1. Quality of life measured by a single item from the WHOQOL-OLD 2. Activities of daily living and functioning measured using the Barthel-Index and the IADL-Scale 3. Subjective health measured by a single question. All will be assessed at baseline (T1), directly after the intervention (T2), as well as at follow-up after 3 months (T3). |
| Overall study start date | 01/06/2018 |
| Completion date | 31/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 130 |
| Total final enrolment | 197 |
| Key inclusion criteria | 1. 60 years of age and older (male/female) 2. Living at home and near the catchment area of the participating psychotherapists (Berlin and neighbouring areas in Brandenburg) 3. Have a long-term care grade (Pflegegrad) (1-5) 4. Presence of clinically relevant depressive symptoms (major depression; adjustment disorder with depressive symptoms; dysthymia) 5. Are willing to participate in one of the two treatments |
| Key exclusion criteria | 1. Moderate to severe dementia 2. Delirium, an acute psychosis or other cognitive disorders 3. Mania or hypomania 4. In the terminal stage of a disease 5. Currently receiving psychotherapy 6. Have communication difficulties or visual or hearing impairments that would severely impact on their capacity to take part in the intervention |
| Date of first enrolment | 25/02/2019 |
| Date of final enrolment | 30/04/2020 |
Locations
Countries of recruitment
- Germany
Study participating centres
Berlin
12247
Germany
Berlin
10117
Germany
Sponsor information
Government
Gutenbergstraße 13
Berlin
10587
Germany
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/05/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository (https://osf.io) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | outcome results | 17/01/2023 | 18/01/2023 | Yes | No |
| Protocol article | 05/08/2020 | 06/03/2024 | Yes | No | |
| Results article | 23/11/2022 | 06/03/2024 | Yes | No | |
| Results article | 21/05/2024 | 22/05/2024 | Yes | No |
Editorial Notes
22/05/2024: Publication reference added.
06/03/2024: Publication references added.
18/01/2023: Publication reference and total final enrollment number added.
15/02/2019: Internal review.
