CClinicalTrials.gg
CompletedNCT07168707EAET-HUpdated May 27, 2026

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

An interventional study of Group-based Emotional Awareness & Expression Therapy - Hebrew in Chronic Musculoskeletal Pain and Cannabis Use, sponsored by Reuth Rehabilitation Hospital. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Reuth Rehabilitation Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Chronic Musculoskeletal Pain
  • Cannabis Use

Keywords

  • Chronic musculoskeletal pain
  • Cannabis Use
  • Emotional Awareness and Expression Therapy
  • Emotional Therapy
  • Psychological Therapy
  • Group-Based
03

In context

Lead sponsor

Reuth Rehabilitation Hospital is the lead sponsor of 16 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  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

Exclusion criteria

Exclusion Criteria:

  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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    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.

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

Interventions

  • OtherGroup-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 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

06

What researchers measure

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.

    Time frame: Baseline and after eight weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline and after eight weeks

  2. 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).

    Time frame: Baseline and after eight weeks

  3. 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.

    Time frame: Baseline and after eight weeks

  4. 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.

    Time frame: Baseline and after eight weeks

  5. 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.

    Time frame: Baseline and after eight weeks

  6. The Satisfaction with Life Scale (SWLS)

    The SWLS is a 5-item self-report questionnaire that measures overall life satisfaction.

    Time frame: Baseline and after eight weeks

  7. 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

    Time frame: Baseline and after eight weeks

  8. 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.

    Time frame: Baseline and after eight weeks

  9. The Fatigue Severity Scale (FSS)

    The FSS is a 9-item self-report questionnaire that measures the impact of fatigue on daily functioning.

    Time frame: Baseline and after eight weeks

  10. 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.

    Time frame: After eight weeks

  11. Medical cannabis consumption

    Three questions regarding the frequency of cannabis use and the method of cannabis consumption.

    Time frame: Baseline and after eight weeks

  12. 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.

    Time frame: Baseline and after eight weeks

Other outcomes

  1. Acceptability questionnaire

    An acceptability questionnaire was developed specifically for the current study, consisting of eight items assessing the participant's acceptance of the program (e.g., satisfaction, perceived usefulness of the content, etc.).

    Time frame: After four weeks and eight weeks

  2. Feasibility measures - Rates of recruitment

    Documentation will be kept of participants who were eligible for the study, gave informed consent, and actively participated in the program. The study will be considered feasible if ≥50% of eligible patients will be enrolled in the study.

    Time frame: After eight weeks

  3. Feasibility measures - Session attendance

    A participant's attendance record will be maintained for each session. The study will be considered feasible if the mean attendance at meetings will be ≥6 of the 8 sessions.

    Time frame: After eight weeks

  4. Feasibility measures - Retention

    A record will be created of participants who completed the program and filled out the post-intervention questionnaires. The study will be considered feasible if ≥70% of enrolled participants will complete the post-intervention survey.

    Time frame: After eight weeks

07

Study locations

1 site
  • Reuth Rehabilitation Hospital
    Tel Aviv, 6772830, Israel
08

References and documents

Publications

  • Lumley M, Ph. Emotional Awareness and Expression Therapy (EAET): A Group-Based Treatment Manual for Patients with Fibromyalgia and Related Centralized Chronic Pain Disorders.
  • 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. PubMed 30461545 ↗

Individual participant data

Plan to share: No — IPD will be shared only with researchers on the study team and not with any individuals outside the team. Additionally, the data will be stored on the computers of the research institute at the hospital where the intervention program is being conducted.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07168707
Lead sponsor
Reuth Rehabilitation Hospital
Collaborators
Tel Aviv University
Responsible party
Sponsor
First posted
Sep 11, 2025
Start date
Jul 9, 2025
Primary completion
Dec 8, 2025
Completion
Dec 8, 2025
Last update
May 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion