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

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Depression

Treatments: Behavioral: treatment-as-usual; Behavioral: EBT

Study type: Interventional

Funder types: Other

Identifiers

NCT02325167

545-12

Details and patient eligibility

About

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.

Full 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).

Enrollment: 130 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

EBT

Experimental group

Treatment:

Behavioral: EBT

Treatment-as-usual

Experimental group

Treatment:

Behavioral: treatment-as-usual