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

NCT02325167 | Completed

• 1 other identifier: 545-12
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

informal caregivers; mental stress; quality of life; psychotherapeutic intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

EBT

EXPERIMENTAL

Behavioral: EBT

Treatment-as-usual

EXPERIMENTAL

Behavioral: treatment-as-usual

Interventions

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

EBT

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

Treatment-as-usual

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 21 years of age
• informal caregivers of palliative patients at last stage of life and during bereavement;
• fluent German language skills

You may not qualify if:

• psychiatric conditions such as schizophrenic disorder, psychotic disorder etc.;
• pronounced cognitive impairment e.g. delirium, dementia

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Stifterverband für die Deutsche Wissenschaft: collaborator

Study Sites (1)

Ludwig Maximilians University Munich

Munich, Germany

Location

MeSH Terms

Conditions

Depression; Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Martin Fegg, Dr.

  Klinik und Poliklinik für Palliativmedizin, Ludwig Maximilians Universität München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Martin Fegg

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Study Start: January 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: January 1, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

DE (1)