Clinical trial NCT02325167: Short-term Existential Behavioural Therapy for Informal Caregivers of Palliative Patients: a Randomised Controlled Trial
Official title: Short-term Existential Behavioural Therapy for Informal Caregivers of Palliative Patients: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: informal caregivers
mental stress
quality of life
psychotherapeutic intervention
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Stifterverband für die Deutsche Wissenschaft
First posted: 2014-12-24
Enrollment: 130
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Secondary outcomes:
measure: Positive and Negative Affect Scale (PANAS; Watson et al., 1988)
timeFrame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
measure: Satisfaction with Life Scale (SWLS; Diener et al., 1985)
timeFrame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
measure: World Health Organisation Quality-of-Life Scale (WHOQOL-BREF; Angermeyer et al., 2000)
timeFrame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
measure: Numeric rating scale for mental stress and quality of life (NRS, range 0-10)
timeFrame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
measure: Generalised Anxiety Disorders-7 (GAD-7; Spitzer et al., 2006)
timeFrame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
measure: Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter (FIMA; Seidl et al., 2014)
timeFrame: Baseline; 6 months follow-up
measure: German version of the NCCN distress-thermometer (Mehnert et al., 2005)
timeFrame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
measure: General Health Questionnaire (GHQ-12, Goldberg et al., 1972)
timeFrame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilians University Munich
Study officials:
affiliation: Klinik und Poliklinik für Palliativmedizin, Ludwig Maximilians Universität München
name: Martin Fegg, Dr.
role: PRINCIPAL_INVESTIGATOR
References: