A Culturally Adapted Group-Based, Emotional Awareness and Expression Therapy Intervention - Hebrew (EAET-H) for Chronic Pain Patients Treated With Medical Cannabis in Israel - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory (BPI) - 4 items of pain severity
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a culturally adapted group-based emotional therapy named "Emotional Awareness and Expression Therapy" can help reduce chronic pain and improve emotional well-being in Israeli adults who suffer from chronic musculoskeletal pain and are treated with medical cannabis.
Researchers will compare patients who receive the emotional therapy along with their usual care to patients who receive usual care only, to see if the therapy leads to better outcomes in pain, mental health, and daily functioning.
Participants will attend a weekly 1.5-hour group therapy session for 8 weeks; Take part in group discussions and emotional processing exercises; Complete questionnaires about pain levels, mood, sleep, and quality of life; Continue their usual medical treatment as prescribed by their doctors.
详细描述
The rising prevalence of chronic pain conditions poses a significant challenge to societies and healthcare systems globally. Despite medical advancements, many individuals continue to face chronic pain daily, with only limited success in alleviating pain and enhancing physical and emotional well-being. Furthermore, the psychological burden associated with chronic pain highlights the critical need for integrating psychological support within chronic pain treatment strategies. Emotional Awareness and Expression Therapy (EAET) has demonstrated considerable reductions in pain and improvements in psychological conditions such as depression and anxiety among adults with various chronic pain types. However, the EAET intervention has never been tested on patients treated with medical Cannabis and has not yet been evaluated in Israel. Furthermore, we propose that adapting the EAET program to reflect local cultural perspectives on pain and its management will be essential for its effective implementation among Israeli patients.
This study aims to culturally adapt the Emotional Awareness and Expression Therapy - Hebrew (EAET-H) eight-session group-based protocol, for Israeli patients with chronic pain receiving medical Cannabis. The study includes a culturally adaptation of the EAET-H according to the steps outlined by Escoffery and colleagues and fidelity assessment through a single-arm pilot trial, which will assess its implementation fidelity, feasibility, acceptability, and preliminary efficacy on pain severity compared to the usual care. The secondary outcome measures that will be assessed in this study are: pain interference and disability, pain catastrophizing, fear and pain believes, mood and satisfaction with life, physical functioning and quality of life, sleep and fatigue, global impression of change, health service utilization and cannabis consumption.
Description of the intervention: An innovative psychological treatment, EAET is a psychotherapeutic approach that emphasizes the role of emotional processing of unresolved trauma, stress and conflict in the treatment of CP and somatic symptoms. The intervention will be delivered as a 1.5-hour weekly group session for a period of 8 weeks. Each session will include two parts, theoretical and practical, and will combine group discussion and sharing experiences.
The study will take place at "Reuth" Rehabilitation Hospital, Tel- Aviv. Chronic musculoskeletal pain patients who are also medical cannabis consumers, treated at the pain and cannabis clinics will be recruited for the study.
Following completion of this research, a well-defined protocol for a group-based EAET program in Hebrew will be developed, tailored to the Israeli context with culture-specific norms and beliefs to effectively meet patients' unique needs. This research aims to provide clear insights into the feasibility and preliminary efficacy of the adapted program through a rigorous pilot trial. This step is marking the first instance this innovative approach, found to be superior to traditional cognitive-behavioural therapy treatments, is tested among pain patients who are treated with medical Cannabis and in Israel. It is expected to significantly reduce pain levels and disability while alleviating the mental strain experienced by patients-areas currently inadequately addressed. The anticipated result is a major advancement in the existing chronic pain treatment paradigm in Israel, incorporating a significant psychological component and capitalizing on the benefits of group therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Diagnosed with any chronic musculoskeletal pain (≥ three months in duration). widespread pain or fibromyalgia or any combination of these conditions;
- •Treated with medical Cannabis;
- •Physical and mental ability to participate in group discussions;
- •Explicitly endorsed an interest in exploring potential emotional factors contributing to their somatic symptoms;
- •Signed informed consent form
排除标准
- •The following conditions will be excluded: confirmed hip/knee osteoarthritis, radiculopathy, electromyography-confirmed "tunnel" syndromes, autoimmune disease that typically generates pain (e.g., rheumatoid arthritis or multiple sclerosis, inflammatory bowel disease, systemic lupus, sickle cell disease), cancer, and chronic infection associated with pain;
- •Severe mental illness or psychiatric disorder such as schizophrenia, bipolar I disorder, multiple personality disorder, or dissociative identity disorder not controlled with medications. In addition, active suicide or violence risk in the past year, active severe alcohol or substance use disorder.
- •Unable to fluently read or converse in Hebrew;
- •Participation in any other clinical study or program focusing on psychological or behavioral intervention.
研究组 & 干预措施
Group-based Emotional Awareness & Expression Therapy - Hebrew (EAET-H)
This pilot study will use the eight-session group EAET manual developed by Mark A. Lumley and Howard Schubiner. Several adaptations to this manual were made: a) Manual's translation to the Hebrew language; b) Adaptations to the Israeli context and setting; c) Manual's language was changed from "fibromyalgia" to "chronic pain" and adaptations were made accordingly. Group participants will receive a class syllabus and an educational booklet of the EAET approach. Each group meeting will be led by two instructors, a psychologist and a physiotherapist.
干预措施: Group-based Emotional Awareness & Expression Therapy - Hebrew (Other)
结局指标
主要结局
Brief Pain Inventory (BPI) - 4 items of pain severity
时间窗: Baseline and after eight weeks
The BPI is a self-report questionnaire used to evaluate pain severity and includes four items. These items assess the intensity of pain at its worst, least, average, and current levels.
次要结局
- Brief Pain Inventory (BPI) - 7 items of pain interference(Baseline and after eight weeks)
- The Hospital Anxiety and Depression Scale (HADS)(Baseline and after eight weeks)
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline and after eight weeks)
- Pain Catastrophizing Scale (PCS)(Baseline and after eight weeks)
- Fear-Avoidance Beliefs Questionnaire (FABQ)(Baseline and after eight weeks)
- The Satisfaction with Life Scale (SWLS)(Baseline and after eight weeks)
- Toronto Alexithymia Scale (TAS)(Baseline and after eight weeks)
- The Pittsburgh Sleep Quality Index (PSQI)(Baseline and after eight weeks)
- The Fatigue Severity Scale (FSS)(Baseline and after eight weeks)
- The Patient Global Impression of Change (PGIC)(After eight weeks)
- Medical cannabis consumption(Baseline and after eight weeks)
- Health care use(Baseline and after eight weeks)