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| Name | Class |
|---|---|
| Stifterverband für die Deutsche Wissenschaft | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBT | Experimental |
| |
| Treatment-as-usual | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBT | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | A reliable and valid 9-item measure of depression | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Affect Scale (PANAS; Watson et al., 1988) | two mood scales, one that measures positive affect and the other which measures negative affect | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up |
| Satisfaction with Life Scale (SWLS; Diener et al., 1985) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Fegg, Dr. | Klinik und Poliklinik für Palliativmedizin, Ludwig Maximilians Universität München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig Maximilians University Munich | Munich | Germany |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| treatment-as-usual | Behavioral | participants assigned to the treatment-as-usual arm will receive 2 supportive sessions delivered by trained therapists at the Clinic of Palliative Care |
|
a short 5-item instrument designed to measure global cognitive judgments of satisfaction with life |
| Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up |
| World Health Organisation Quality-of-Life Scale (WHOQOL-BREF; Angermeyer et al., 2000) | an abbreviated 26-item generic Quality of Life Scale developed through the World Health Organisation measuring physical health, psychological health, social relationships, and environment | 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) | a numeric scale used for the subjective measurement of mental stress and quality of life | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up |
| Generalised Anxiety Disorders-7 (GAD-7; Spitzer et al., 2006) | a 7-item self-report measure designed to screen and assess the severity of generalised anxiety disorder symptoms | 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) | a german questionnaire for health-related resource use | Baseline; 6 months follow-up |
| German version of the NCCN distress-thermometer (Mehnert et al., 2005) | a subjective measurement of distress on a 0-10 scale | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up |
| General Health Questionnaire (GHQ-12, Goldberg et al., 1972) | a 12-item self-report measure of psychological morbidity | Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up |