Depression
Conditions
Keywords
informal caregivers, mental stress, quality of life, psychotherapeutic intervention
Brief summary
The purpose of the study is to test the effectiveness of a short-term manualised individual psychotherapy, called Existential Behavioural Therapy (EBT), to prevent depression in informal caregivers of palliative patients.
Detailed description
The investigators have developed and pilot-tested a short-term manualised individual psychotherapy, called Existential Behavioural Therapy (EBT), to reduce psychological distress in informal caregivers of palliative patients. The investigators propose to conduct a two-arm randomised controlled trial (RCT) to test the effectiveness of EBT against usual care for the reduction of distress and the promotion of quality of life. Two one-to-one manualised psychotherapeutic sessions will be compared to a treatment-as-usual control group.Treatment-as-usual includes two supportive sessions. The design will be an unblinded RCT consisting of two conditions (EBT and Treatment-as-usual), with assessment at pre- and post-treatment and follow-ups at four weeks and six months. The trial will take place in the Clinic of Palliative Care, University of Munich (Klinik und Poliklinik für Palliativmedizin der LMU München).
Interventions
BEHAVIORALEBT
participants assigned to the intervention arm will receive 2 manualised therapy sessions with focus on mindfulness and activating resources delivered by trained therapists at the Clinic of Palliative Care
BEHAVIORALtreatment-as-usual
participants assigned to the treatment-as-usual arm will receive 2 supportive sessions delivered by trained therapists at the Clinic of Palliative Care
Sponsors
Stifterverband für die Deutsche Wissenschaft
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 21 years of age * informal caregivers of palliative patients at last stage of life and during bereavement; * fluent German language skills
Exclusion criteria
* psychiatric conditions such as schizophrenic disorder, psychotic disorder etc.; * pronounced cognitive impairment e.g. delirium, dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up | A reliable and valid 9-item measure of depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with Life Scale (SWLS; Diener et al., 1985) | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up | a short 5-item instrument designed to measure global cognitive judgments of satisfaction with life |
| World Health Organisation Quality-of-Life Scale (WHOQOL-BREF; Angermeyer et al., 2000) | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up | an abbreviated 26-item generic Quality of Life Scale developed through the World Health Organisation measuring physical health, psychological health, social relationships, and environment |
| Numeric rating scale for mental stress and quality of life (NRS, range 0-10) | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up | a numeric scale used for the subjective measurement of mental stress and quality of life |
| Positive and Negative Affect Scale (PANAS; Watson et al., 1988) | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up | two mood scales, one that measures positive affect and the other which measures negative affect |
| Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter (FIMA; Seidl et al., 2014) | Baseline; 6 months follow-up | a german questionnaire for health-related resource use |
| German version of the NCCN distress-thermometer (Mehnert et al., 2005) | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up | a subjective measurement of distress on a 0-10 scale |
| General Health Questionnaire (GHQ-12, Goldberg et al., 1972) | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up | a 12-item self-report measure of psychological morbidity |
| Generalised Anxiety Disorders-7 (GAD-7; Spitzer et al., 2006) | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up | a 7-item self-report measure designed to screen and assess the severity of generalised anxiety disorder symptoms |
Countries
Germany
Outcome results
None listed