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Clinical Trial NCT07168707 (EAET-H) for Chronic Musculoskeletal Pain, Cannabis Use is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Culturally Adapted EAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Pilot Study 8 Exercise-Based

Recruiting
Clinical Trial NCT07168707 (EAET-H) is an interventional study for Chronic Musculoskeletal Pain, Cannabis Use that is recruiting. It started on 9 July 2025 with plans to enroll 8 participants. Led by Reuth Rehabilitation Hospital, it is expected to complete by 1 January 2026. The latest data from ClinicalTrials.gov was last updated on 11 September 2025.
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...

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Detailed Description
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 psyc...Show More
Official Title

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

Conditions
Chronic Musculoskeletal PainCannabis Use
Publications
Scientific articles and research papers published about this clinical trial:
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Other Study IDs
  • EAET-H
  • 0017-21-RRH
NCT ID Number
Start Date (Actual)
2025-07-09
Last Update Posted
2025-09-11
Completion Date (Estimated)
2026-01-01
Enrollment (Estimated)
8
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Chronic musculoskeletal pain
Cannabis Use
Emotional Awareness and Expression Therapy
Emotional Therapy
Psychological Therapy
Group-Based
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGroup-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 ...Show More
Group-based Emotional Awareness & Expression Therapy - Hebrew
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 ...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Brief Pain Inventory (BPI) - 7 items of pain interference
The BPI is a self-report questionnaire used to assess the impact of pain on daily functioning. Its seven pain interference items measure how pain affects activities such as general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life.
Baseline and after eight weeks
The Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item self-report questionnaire designed to assess symptoms of anxiety and depression in non-psychiatric hospital patients. It consists of two subscales-seven items each for anxiety (HADS-A) and depression (HADS-D).
Baseline and after eight weeks
Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ is a 10-item self-report tool designed to assess the confidence of individuals with chronic pain in performing daily activities despite their pain.
Baseline and after eight weeks
Pain Catastrophizing Scale (PCS)
The PCS is a 13-item questionnaire that measures negative thought patterns related to pain. It assesses three components: rumination, magnification, and helplessness. Higher scores indicate greater levels of pain catastrophizing.
Baseline and after eight weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a self-report tool that assesses the extent to which fear and avoidance beliefs about physical activity and work contribute to a person's chronic pain. It consists of 11 items divided into two subscales: physical activity and work.
Baseline and after eight weeks
The Satisfaction with Life Scale (SWLS)
The SWLS is a 5-item self-report questionnaire that measures overall life satisfaction.
Baseline and after eight weeks
Toronto Alexithymia Scale (TAS)
The TAS is a 20-item self-report questionnaire that can be used to identify issues relating to alexithymia, such as difficulty identifying and describing feelings and externally oriented thinking
Baseline and after eight weeks
The Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item self-report questionnaire that assesses sleep quality and disturbances over a 1-month period. It yields a global score based on seven components, including sleep duration, latency, and disturbances.
Baseline and after eight weeks
The Fatigue Severity Scale (FSS)
The FSS is a 9-item self-report questionnaire that measures the impact of fatigue on daily functioning.
Baseline and after eight weeks
The Patient Global Impression of Change (PGIC)
The PGIC is a single-item self-report measure that assesses a patient's overall perception of improvement or decline following treatment.
After eight weeks
Medical cannabis consumption
Three questions regarding the frequency of cannabis use and the method of cannabis consumption.
Baseline and after eight weeks
Health care use
Four questions regarding the medications the patient takes regularly, the treatments they receive and their frequency, and doctor visits within the past three months.
Baseline and after eight weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Diagnosed with any chronic musculoskeletal pain (≥ three months in duration). widespread pain or fibromyalgia or any combination of these conditions;
  2. Treated with medical Cannabis;
  3. Physical and mental ability to participate in group discussions;
  4. Explicitly endorsed an interest in exploring potential emotional factors contributing to their somatic symptoms;
  5. Signed informed consent form

  1. 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;
  2. 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.
  3. Unable to fluently read or converse in Hebrew;
  4. Participation in any other clinical study or program focusing on psychological or behavioral intervention.
Reuth Rehabilitation Hospital logoReuth Rehabilitation Hospital
Tel Aviv University logoTel Aviv University
Study Central Contact
Contact: Pnina Marom, M.P.H.; Ph.D. Student, +972-526134797, [email protected]
Contact: Shahar Lev-Ari, Ph.D., [email protected]
1 Study Locations in 1 Countries
Reuth Rehabilitation Hospital, Tel Aviv, 6772830, Israel
Keren Sivan-Speier, M.D, Contact, +972-732701610, [email protected]
Recruiting