Chronic Musculoskeletal PainEAET-HNCT07168707
Culturally Adapted EAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Pilot Study
A study testing Group-based Emotional Awareness & Expression Therapy - Hebrew in people with Chronic Musculoskeletal Pain and Cannabis Use, run by Reuth Rehabilitation Hospital at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain, Cannabis Use
- What is being tested?
- Group-based Emotional Awareness & Expression Therapy - Hebrew
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Jul 2025to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Chronic Musculoskeletal Pain, Cannabis Use
- Being tested
- Group-based Emotional Awareness & Expression Therapy - Hebrew
- Keywords
- Chronic musculoskeletal pain, Cannabis Use, Emotional Awareness and Expression Therapy, Emotional Therapy, Psychological Therapy, Group-Based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based Emotional Awareness & Expression Therapy - HebrewOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Group-based Emotional Awareness & Expression Therapy - Hebrew |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after eight weeks
Secondary outcomes (12)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After eight weeks
Medical cannabis consumption
Three questions regarding the frequency of cannabis use and the method of cannabis consumption.
Measured: 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.
Measured: Baseline and after eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start9 Jul 2025
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm pilot study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reuth Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168707
- Sponsor's protocol ID
- 0017-21-RRH
- Acronym
- EAET-H
- Status last verified
- May 2026
- First submitted
- 16 Aug 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07168707
- Acronym / sponsor ID
- EAET-H / 0017-21-RRH
- Conditions
- Chronic Musculoskeletal Pain, Cannabis Use
- Keywords
- Chronic musculoskeletal pain, Cannabis Use, Emotional Awareness and Expression Therapy, Emotional Therapy, Psychological Therapy, Group-Based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Reuth Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm pilot study
| Arm | Type | Receives |
|---|---|---|
| Group-based Emotional Awareness & Expression Therapy - Hebrew (EAET-H) | Experimental | Other: Group-based Emotional Awareness & Expression Therapy - HebrewThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based Emotional Awareness & Expression Therapy - HebrewAlso: EAET-HThis 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 (EAET-H) |
Primary outcome
Brief Pain Inventory (BPI) - 4 items of pain severity
Time frame: Baseline and after eight weeks
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.
12 secondary outcomes
Brief Pain Inventory (BPI) - 7 items of pain interference
Time frame: Baseline and after eight weeks
The Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and after eight weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Baseline and after eight weeks
Pain Catastrophizing Scale (PCS)
Time frame: Baseline and after eight weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Baseline and after eight weeks
The Satisfaction with Life Scale (SWLS)
Time frame: Baseline and after eight weeks
Toronto Alexithymia Scale (TAS)
Time frame: Baseline and after eight weeks
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and after eight weeks
The Fatigue Severity Scale (FSS)
Time frame: Baseline and after eight weeks
The Patient Global Impression of Change (PGIC)
Time frame: After eight weeks
Medical cannabis consumption
Time frame: Baseline and after eight weeks
Health care use
Time frame: Baseline and after eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- BackgroundLumley M, Ph. Emotional Awareness and Expression Therapy (EAET): A Group-Based Treatment Manual for Patients with Fibromyalgia and Related Centralized Chronic Pain Disorders.
- Background: PubMed 30461545Lumley 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based Emotional Awareness & Expression Therapy - Hebrew in people with Chronic Musculoskeletal Pain and Cannabis Use, run by Reuth Rehabilitation Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) - 4 items of pain severity (time frame: Baseline and after eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07168707, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.