Short-term Existential Behavioural Therapy for Informal Caregivers of Palliative Patients: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 21 years of age
- •informal caregivers of palliative patients at last stage of life and during bereavement;
- •fluent German language skills
排除标准
- •psychiatric conditions such as schizophrenic disorder, psychotic disorder etc.;
- •pronounced cognitive impairment e.g. delirium, dementia
研究组 & 干预措施
EBT
干预措施: EBT (Behavioral)
Treatment-as-usual
干预措施: treatment-as-usual (Behavioral)
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
A reliable and valid 9-item measure of depression
次要结局
- 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)
- Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter (FIMA; Seidl et al., 2014)(Baseline; 6 months follow-up)
- German version of the NCCN distress-thermometer (Mehnert et al., 2005)(Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up)
- General Health Questionnaire (GHQ-12, Goldberg et al., 1972)(Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up)
研究者
Martin Fegg
PD Dr. Martin Fegg
Ludwig-Maximilians - University of Munich