Emotion-Focused Therapy in the Treatment of Prolonged Grief Disorder: Study Protocol for a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Prolonged Grief Scale 13 - Revised
研究概览
简要总结
The goal of this clinical trial is to learn if Emotion-Focused Therapy (EFT) works to reduce symptoms of Prolonged Grief Disorder (PGD) in adults. PGD happens when the pain of losing a loved one lasts a long time and causes serious problems in daily life.
- The main questions this study aims to answer are:
- Does EFT lower grief symptoms in adults with PGD?
- Does EFT also help with related problems, such as anxiety, depression, trauma, and overall distress?
- Who can take part:
Adults (18 years or older) who lost a loved one at least 6 months ago and meet the criteria for PGD.
- What will happen in the study:
Participants will be randomly assigned to one of two groups:
- EFT group: 8 to 10 weekly, face-to-face therapy sessions with a trained therapist.
- Self-help group: 10 weekly self-help exercises based on EFT, completed on their own.
- All participants will complete questionnaires on grief, mood, and well-being before starting, during the study, at the end of treatment (12 weeks), and again at 5 months and 12 months after starting.
- In the EFT group, the therapeutic relationship will also be measured during sessions 3 and 8.
- Why this study is important:
Most current treatments for grief are based on cognitive-behavioral therapy, but not everyone benefits from them. EFT is a promising therapy that focuses on emotions and has shown positive results for other mental health problems. This trial will test if EFT can be an effective treatment for people struggling with prolonged grief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years).
- •Undergoing a grief process (including perinatal grief).
- •Meeting ICD-11 diagnostic criteria for Prolonged Grief Disorder, assessed with the Traumatic Grief Inventory - Clinician Administered (TGI-CA); death occurred six months or more prior to assessment; PG-13-R score ≥
- •Provision of informed consent.
- •Stable psychopharmacological medication for at least six weeks prior to therapy onset, with physician approval to maintain stability during the intervention.
排除标准
- •Concurrent psychological treatment
- •Bereavement occurring less than six months prior to the loss
- •Substance abuse
- •Eating disorder
- •Psychosis;
- •Organic brain syndrome
- •Suicide risk
- •Risk of harm to others.
研究组 & 干预措施
Emotion-Focused Therapy for Grief
干预措施: Emotion-Focused Therapy for Grief (Behavioral)
self-help intervention based on Emotion-Focused Therapy
干预措施: Self-help intervention based on EFT (Behavioral)
结局指标
主要结局
Prolonged Grief Scale 13 - Revised
时间窗: From enrollment to the end of the research at 1 year follow-up
Higher scores indicate greater symptomatology of Prolonged Grief Disorder; a score of 30 or higher meets the clinical threshold for Prolonged Grief Disorder.
次要结局
- TGI-CA(Post-treatment (12 weeks), 5-month and 12-month follow-up)
- Patients Health Questionnarie 9(From enrollment to the end of the reserch at 1 year follow-up)
- Centrality of Event Scale(From enrollment to the end of the reserch at 1 year follow-up)
- Clinical Outcomes in Routine Evaluation-10(From enrollment to the end of the reserch at 1 year follow-up)
- Generalized Anxiety Disorder-7 Scale(From enrollment to the end of the reserch at 1 year follow-up)
研究者
José Gamoneda Larripa
Associate professor
Universidad Pontificia Comillas