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Completed

NCT Number: NCT02325167

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Stress, Psychological

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ludwig Maximilians University Munich

Munich, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up

    A reliable and valid 9-item measure of depression

Secondary outcomes

  1. Positive and Negative Affect Scale (PANAS; Watson et al., 1988)

    Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up

    two mood scales, one that measures positive affect and the other which measures negative affect

  2. Satisfaction with Life Scale (SWLS; Diener et al., 1985)

    Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up

    a short 5-item instrument designed to measure global cognitive judgments of satisfaction with life

  3. World Health Organisation Quality-of-Life Scale (WHOQOL-BREF; Angermeyer et al., 2000)

    Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up

    an abbreviated 26-item generic Quality of Life Scale developed through the World Health Organisation measuring physical health, psychological health, social relationships, and environment

  4. Numeric rating scale for mental stress and quality of life (NRS, range 0-10)

    Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up

    a numeric scale used for the subjective measurement of mental stress and quality of life

  5. Generalised Anxiety Disorders-7 (GAD-7; Spitzer et al., 2006)

    Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up

    a 7-item self-report measure designed to screen and assess the severity of generalised anxiety disorder symptoms

  6. Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter (FIMA; Seidl et al., 2014)

    Time frame: Baseline; 6 months follow-up

    a german questionnaire for health-related resource use

  7. German version of the NCCN distress-thermometer (Mehnert et al., 2005)

    Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up

    a subjective measurement of distress on a 0-10 scale

  8. General Health Questionnaire (GHQ-12, Goldberg et al., 1972)

    Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up

    a 12-item self-report measure of psychological morbidity

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Stifterverband für die Deutsche Wissenschaft

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Dec 24, 2014
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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