vEAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Feasibility Study

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. Faced with these challenges, numerous individuals with chronic pain have experimented with medical cannabis as an alternative form of pain management. 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 types of chronic pain. However, the EAET intervention has never been tested in patients treated with medical cannabis and has not yet been evaluated in Israel. Our preliminary pilot trial culturally adapted the EAET protocol into Hebrew and evaluated it in a face-to-face format. In the subsequent phase, the program will be delivered in a virtual format, rather than in person, based on insights derived from the pilot study.

This study aims to assess the feasibility, acceptability, and preliminary efficacy of a culturally adapted, eight-session, group-based virtual EAET-Hebrew intervention through a feasibility trial. The primary outcome is pain severity. The secondary outcome measures that will be assessed in this study are: pain interference and disability, pain catastrophizing, fear and pain beliefs, 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 chronic pain and somatic symptoms. The intervention will be delivered as a 1.5-hour virtual weekly group session over a period of 8 weeks, although the first session will be held in-person at the hospital's clinic. Each session will include two parts, theoretical and practical, and will combine group discussion and the sharing of experiences.

The study will take place at "Reuth" Rehabilitation Hospital, Tel Aviv. Patients with chronic musculoskeletal pain who are also medical cannabis consumers and are treated at the pain and cannabis clinics will be recruited for the study.

Following completion of this research, a well-defined protocol for a virtual group-based EAET program in Hebrew will be developed, tailored to the Israeli context with culture-specific norms and beliefs to meet patients' unique needs effectively. This research aims to provide clear insights into the feasibility and preliminary efficacy of the adapted program through a rigorous feasibility pilot trial. This step marks the first instance in which 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 reduce pain levels and disability while alleviating the mental strain experienced by patients, areas that are 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 in a virtual format that is accessible to patients.

• Brief Pain Inventory (BPI) - 7 items of pain interference [Срок оценки: Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]
• The Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]
• Pain Self-Efficacy Questionnaire (PSEQ) [Срок оценки: Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]
• Pain Catastrophizing Scale (PCS) [Срок оценки: Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]
• Fear-Avoidance Beliefs Questionnaire (FABQ) [Срок оценки: Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]
• The Satisfaction with Life Scale (SWLS) [Срок оценки: Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]
• Toronto Alexithymia Scale (TAS) [Срок оценки: Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]
• The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]
• The Fatigue Severity Scale (FSS) [Срок оценки: Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]
• The Patient Global Impression of Change (PGIC) [Срок оценки: Post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]
• Medical cannabis consumption [Срок оценки: Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]
• Health care use [Срок оценки: Pre-intervention (baseline), post-intervention (8 weeks after baseline), and follow-up (one month post-intervention)]