vEAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorReuth Rehabilitation Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Group-based virtual Emotional Awareness & Expression Therapy - Hebrew (vEAET-H)
Other interventionThis 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.
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Group-based vEAET-HExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)Secondary outcomes
1
Brief Pain Inventory (BPI) - 7 items of pain interference
The Brief Pain Inventory (BPI) pain interference subscale is a self-report measure used to assess the extent to which pain interferes with daily functioning. It comprises seven items assessing general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Each item is rated on an 11-point numerical rating scale ranging from 0 ("does not interfere") to 10 ("completely interferes"). The overall pain interference score is calculated as the mean of the seven items and ranges from 0 to 10, with higher scores indicating greater pain-related interference and therefore a worse outcome.
Time frame
Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)2
The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire designed to assess symptoms of anxiety and depression in non-psychiatric hospital populations. It comprises two seven-item subscales: the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) and the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D). Each item is rated on a 4-point scale ranging from 0 to 3. Scores for each subscale are calculated by summing the seven corresponding items and range from 0 to 21, with higher scores indicating greater anxiety or depressive symptom severity and therefore a worse outcome.
Time frame
Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)3
Pain Self-Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item self-report measure designed to assess individuals' confidence in performing daily activities despite chronic pain. Each item is rated on a 7-point scale ranging from 0 ("not at all confident") to 6 ("completely confident"). Item scores are summed to produce a total score ranging from 0 to 60, with higher scores indicating greater pain self-efficacy and therefore a better outcome.
Time frame
Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)4
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a 13-item self-report questionnaire designed to assess negative thoughts and feelings related to pain. It comprises three subscales: rumination, magnification, and helplessness. Each item is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("all the time"). Item scores are summed to produce a total score ranging from 0 to 52, with higher scores indicating greater pain catastrophizing and therefore a worse outcome.
Time frame
Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)Other outcomes
1
Acceptability questionnaire
A 12-item acceptability questionnaire was developed specifically for the current study to assess participants' acceptance of the intervention, including satisfaction, perceived effectiveness, perceived burden, intervention coherence, adherence, and intention to continue using the intervention skills. Each item is rated on a 5-point scale ranging from 0 ("strongly disagree") to 4 ("strongly agree"). The overall acceptability score is calculated as the mean of the 12 items and ranges from 0 to 4, with higher scores indicating greater intervention acceptability and satisfaction and therefore a better outcome.
Time frame
Mid-intevention (4 weeks after baseline), post-intervention (8 weeks after baseline)2
Feasibility measures
Feasibility will be assessed with rates of recruitment, session attendance, and retention. The study will be considered feasible if ≥50% of eligible patients will be enrolled in the study (recruitment), mean attendance at meetings will be ≥6 of the 8 sessions (attendance), and ≥70% of enrolled participants will complete the post-intervention survey (retention).
Time frame
Post-intervention (8 weeks after baseline)Sponsors and contacts
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Source ClinicalTrials.gov