vEAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Feasibility Study

N/ARecruitingNCT07732062

Reuth Rehabilitation Hospital42 enrolled

Overview

The goal of this clinical trial is to evaluate whether a culturally adapted, virtual, group-based emotional therapy called Emotional Awareness and Expression Therapy is feasible and whether it can help reduce chronic pain and improve emotional well-being among Israeli adults who suffer from chronic musculoskeletal pain and are treated with medical cannabis. Participants will attend a weekly 1.5-hour virtual group therapy session for 8 weeks, except for the first session, which will be held in-person at the hospital's clinic. The participants will take part in group discussions and emotional processing exercises, complete questionnaires about pain levels, mood, sleep, and quality of life, and continue their usual medical treatment as prescribed by their doctors.

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. Faced with these challenges, numerous individuals with chronic pain have experimented with medical cannabis as an alternative form of pain management. 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 types of chronic pain. However, the EAET intervention has never been tested in patients treated with medical cannabis and has not yet been evaluated in Israel. Our preliminary pilot trial culturally adapted the EAET protocol into Hebrew and evaluated it in a face-to-face format. In the subsequent phase, the program will be delivered in a virtual format, rather than in person, based on insights derived from the pilot study. This study aims to assess the feasibility, acceptability, and preliminary efficacy of a culturally adapted, eight-session, group-based virtual EAET-Hebrew intervention through a feasibility trial. The primary outcome is pain severity. The secondary outcome measures that will be assessed in this study are: pain interference and disability, pain catastrophizing, fear and pain beliefs, 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 chronic pain and somatic symptoms. The intervention will be delivered as a 1.5-hour virtual weekly group session over a period of 8 weeks, although the first session will be held in-person at the hospital's clinic. Each session will include two parts, theoretical and practical, and will combine group discussion and the sharing of experiences. The study will take place at "Reuth" Rehabilitation Hospital, Tel Aviv. Patients with chronic musculoskeletal pain who are also medical cannabis consumers and are treated at the pain and cannabis clinics will be recruited for the study. Following completion of this research, a well-defined protocol for a virtual group-based EAET program in Hebrew will be developed, tailored to the Israeli context with culture-specific norms and beliefs to meet patients' unique needs effectively. This research aims to provide clear insights into the feasibility and preliminary efficacy of the adapted program through a rigorous feasibility pilot trial. This step marks the first instance in which 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 reduce pain levels and disability while alleviating the mental strain experienced by patients, areas that are 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 in a virtual format that is accessible to patients.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosed with any chronic musculoskeletal pain (≥ three months in duration) including back, neck, limb or pelvic pain, tension headache and fibromyalgia; 2. Treated with medical Cannabis; 3. Physical and mental ability to participate in group discussions; 4. Fluent in reading and speaking Hebrew. Exclusion Criteria: 1. Chronic pain conditions not classified as chronic primary pain. These include neuropathies such as carpal or tarsal tunnel syndrome, radiculopathy, and neuralgia; 2. Primary headache disorders such as cluster headaches; 3. Cancer-related pain; 4. Burn- or infection-related chronic pain; 5. Autoimmune diseases typically associated with pain, including rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, systemic lupus erythematosus, and sickle cell disease; 6. Inflammatory systemic diseases causing pain, including osteoarthritis or gout. 7. Severe mental illness or psychiatric disorder such as schizophrenia, bipolar I disorder, multiple personality disorder, or dissociative identity disorder not controlled with medications, active suicide or violence risk in the past year, active severe alcohol or substance use disorder, self-reported use of intravenous drugs. 8. Participant with a significant negative life event within the past six months, such as the death of a close person, significant loss of income, or another traumatic or highly stressful event, which may substantially affect the participant's emotional state, safety, or ability to participate in the intervention; 9. Current participation in another psychological or behavioral therapy, program, or clinical study.

Outcomes

Primary Outcomes

Brief Pain Inventory (BPI) - 4 items of pain severity

The Brief Pain Inventory (BPI) pain severity subscale is a self-report measure comprising four items that assess pain intensity at its worst, least, average, and current levels. Each item is rated on a 10-point numerical rating scale ranging from 0 ("no pain") to 10 ("pain as bad as you can imagine"). The overall pain severity score is calculated as the mean of the four items and ranges from 0 to 10, with higher scores indicating greater pain severity and therefore a worse outcome.