Culturally Adapted EAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Pilot Study

NCT07168707 | Recruiting

• 1 other identifier: 0017-21-RRH
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Musculoskeletal Pain; Cannabis Use

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and after eight weeks

Secondary Outcomes (12)

• 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

Other Outcomes (4)

• Acceptability questionnaire

  After four weeks and eight weeks

• Feasibility measures - Rates of recruitment

  After eight weeks

• Feasibility measures - Session attendance

  After eight weeks

Study Arms (1)

Group-based Emotional Awareness & Expression Therapy - Hebrew (EAET-H)

EXPERIMENTAL

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.

Other: Group-based Emotional Awareness & Expression Therapy - Hebrew

Interventions

Group-based Emotional Awareness & Expression Therapy - Hebrew OTHER

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.

Also known as: EAET-H

Group-based Emotional Awareness & Expression Therapy - Hebrew (EAET-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). 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reuth Rehabilitation Hospital: lead
• Tel Aviv University: collaborator

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, 6772830, Israel

RECRUITING

Related Publications (2)

• Lumley M, Ph. Emotional Awareness and Expression Therapy (EAET): A Group-Based Treatment Manual for Patients with Fibromyalgia and Related Centralized Chronic Pain Disorders.

  BACKGROUND

• 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

Central Study Contacts

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

CONTACT

+972-526134797; pninamarom87@gmail.com

Shahar Lev-Ari, Ph.D.

CONTACT

leva@tauex.tau.ac.il

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 pilot study

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: September 11, 2025
• Study Start: July 9, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)