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

NCT ID: NCT02325167

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-01-31

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).

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

EBT

Group Type: EXPERIMENTAL

EBT

Intervention Type: 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

Treatment-as-usual

Group Type: EXPERIMENTAL

treatment-as-usual

Intervention Type: BEHAVIORAL

participants assigned to the treatment-as-usual arm will receive 2 supportive sessions delivered by trained therapists at the Clinic of Palliative Care

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stifterverband für die Deutsche Wissenschaft

UNKNOWN

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Martin Fegg

PD Dr. Martin Fegg

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Fegg, Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik und Poliklinik für Palliativmedizin, Ludwig Maximilians Universität München

Locations

Ludwig Maximilians University Munich

Munich, , Germany

Countries

Germany

Other Identifiers

545-12

Identifier Type: -

Identifier Source: org_study_id