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

NCT07732062 | Recruiting

• 1 other identifier: 0017.1-21-RRH
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Musculoskeletal Pain; Cannabis Use

Keywords

Chronic musculoskeletal pain; Cannabis Use; Emotional Awareness and Expression Therapy; Emotional Therapy; Psychological Therapy; Group-Based; telehealth

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)

Secondary Outcomes (12)

• Brief Pain Inventory (BPI) - 7 items of pain interference

  Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)

• The Hospital Anxiety and Depression Scale (HADS)

  Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)

• Pain Self-Efficacy Questionnaire (PSEQ)

  Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)

• Pain Catastrophizing Scale (PCS)

  Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)

• Fear-Avoidance Beliefs Questionnaire (FABQ)

  Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)

Other Outcomes (2)

• Acceptability questionnaire

  Mid-intevention (4 weeks after baseline), post-intervention (8 weeks after baseline)

• Feasibility measures

  Post-intervention (8 weeks after baseline)

Study Arms (1)

Group-based vEAET-H

EXPERIMENTAL

Group-based Virtual Emotional Awareness \& Expression Therapy - Hebrew

Other: Group-based virtual Emotional Awareness & Expression Therapy - Hebrew (vEAET-H)

Interventions

Group-based virtual Emotional Awareness & Expression Therapy - Hebrew (vEAET-H) OTHER

This study will use the culturally adapted, eight-session, group-based EAET manual, originally developed by Mark A. Lumley and Howard Schubiner, in an online format. However, the first session will be held in-person at the hospital's clinic. Several adaptations to this manual were made: a) translation of the manual into Hebrew; b) adaptations to the Israeli context and setting; and c) the 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 for the vEAET-H program.

Group-based vEAET-H

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with any chronic musculoskeletal pain (≥ three months in duration) including back, neck, limb or pelvic pain, tension headache and fibromyalgia;
• Treated with medical Cannabis;
• Physical and mental ability to participate in group discussions;
• Fluent in reading and speaking Hebrew.

You may not qualify if:

• Chronic pain conditions not classified as chronic primary pain. These include neuropathies such as carpal or tarsal tunnel syndrome, radiculopathy, and neuralgia;
• Primary headache disorders such as cluster headaches;
• Cancer-related pain;
• Burn- or infection-related chronic pain;
• Autoimmune diseases typically associated with pain, including rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, systemic lupus erythematosus, and sickle cell disease;
• Inflammatory systemic diseases causing pain, including osteoarthritis or gout.
• 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.
• 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;
• Current participation in another psychological or behavioral therapy, program, or clinical study.

Sponsors & Collaborators

• Reuth Rehabilitation Hospital: lead

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, 6772830, Israel

RECRUITING

Related Publications (2)

• Lumley MA, Schubiner H. Psychological Therapy for Centralized Pain: An Integrative Assessment and Treatment Model. Psychosom Med. 2019 Feb/Mar;81(2):114-124. doi: 10.1097/PSY.0000000000000654.

  PMID: 30461545 BACKGROUND

• Lumley MA, Schubiner H. Emotional Awareness and Expression Therapy for Chronic Pain: Rationale, Principles and Techniques, Evidence, and Critical Review. Curr Rheumatol Rep. 2019 May 23;21(7):30. doi: 10.1007/s11926-019-0829-6.

  PMID: 31123837 BACKGROUND

Study Officials

• Keren Sivan-Speier, M.D.

  Reuth Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahar Lev-Ari, Ph.D.

CONTACT

+972-36407742; leva@tauex.tau.ac.il

Pnina Marom, M.P.H.; Ph.D. Student

CONTACT

pninamarom87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm feasibility study

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)