Short-term Existential Behavioural Therapy for Informal Caregivers of Palliative Patients: a Randomised Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Short-term Existential Behavioural Therapy for Informal Caregivers of Palliative Patients: a Randomised Controlled Trial

Conditions
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Depression

Intervention / Treatment
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* Behavioral: EBT
* Behavioral: treatment-as-usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBT<br> | Behavioral: EBT<br>* 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<br>|
| Experimental: Treatment-as-usual<br> | Behavioral: treatment-as-usual<br>* participants assigned to the treatment-as-usual arm will receive 2 supportive sessions delivered by trained therapists at the Clinic of Palliative Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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informal caregivers, mental stress, quality of life, psychotherapeutic intervention