Short-term Existential Behavioural Therapy for Informal Caregivers of Palliative Patients: a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Patient Health Questionnaire-9 (PHQ-9)
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
A reliable and valid 9-item measure of depression
Secondary Outcomes
- Positive and Negative Affect Scale (PANAS; Watson et al., 1988)(Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up)
- Satisfaction with Life Scale (SWLS; Diener et al., 1985)(Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up)
- World Health Organisation Quality-of-Life Scale (WHOQOL-BREF; Angermeyer et al., 2000)(Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up)
- 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)
- Generalised Anxiety Disorders-7 (GAD-7; Spitzer et al., 2006)(Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up)
- Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter (FIMA; Seidl et al., 2014)(Baseline; 6 months follow-up)
- German version of the NCCN distress-thermometer (Mehnert et al., 2005)(Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up)
- General Health Questionnaire (GHQ-12, Goldberg et al., 1972)(Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up)
Investigators
Martin Fegg
PD Dr. Martin Fegg
Ludwig-Maximilians - University of Munich