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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: EBT; Behavioral: treatment-as-usual

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • Ludwig Maximilians University Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EBT	Behavioral: EBT; 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
Experimental: Treatment-as-usual	Behavioral: treatment-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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Stifterverband für die Deutsche Wissenschaft
• Investigators: Principal Investigator: Martin Fegg, Dr., Klinik und Poliklinik für Palliativmedizin, Ludwig Maximilians Universität München

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: December 19, 2014
• First Submitted That Met QC Criteria: December 23, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; informal caregivers; mental stress; psychotherapeutic intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 545-12