RecruitingACTRN12625000350426

Evaluating the feasibility of a new brief psychological intervention for people living with chronic pain who use prescription opioid medications

A pilot feasibility study of a brief psychological intervention (OMED Assist) to provide prescription opioid medication assistance to people living with chronic non-cancer pain


Sponsor

The University of Queensland

Enrollment

20 participants

Start Date

Sep 23, 2025

Study Type

Interventional

Conditions

Summary

To evaluate the feasibility of a brief psychological intervention, OMED Assist in practice for patients with chronic non-cancer pain who may be at risk of potentially harmful prescription opioid use in a prospective non-randomised pilot study.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic pain that does not respond to standard treatments is a significant burden, and many people living with it are prescribed opioid medications long-term. While opioids can help, they also carry risks — including dependence and potential for misuse. This study is testing a brief psychological program called OMED Assist, designed to help people with chronic pain understand and manage their opioid use more safely, without requiring lengthy therapy programmes. Participants will receive the OMED Assist intervention through a specialist pain clinic and will be followed to see whether it is practical to deliver and whether people find it helpful. This is a pilot study to determine how to best run a larger future trial. You may be eligible if you are aged 18 to 70, have a diagnosis of chronic non-cancer pain, are currently seeking care through a pain specialist service, rate your current pain as above 4 out of 10, and are considered at some risk of opioid misuse (based on a brief screening questionnaire). People with severe psychological distress, recent injecting drug use, or without internet access (if they cannot attend in person) are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The OMED Assist intervention is a brief psychological intervention. It includes four online modules and the patient is supported by four clinician-guided phone/zoom calls. The design of the interventi

The OMED Assist intervention is a brief psychological intervention. It includes four online modules and the patient is supported by four clinician-guided phone/zoom calls. The design of the intervention includes motivational interviewing techniques and cognitive behavioural therapy to support people to make changes towards their pain management goals, including reducing any potential harm associated with their opioid medication use. The intervention will be delivered by psychologists or provisional psychologists who have training in motivational interviewing and experience delivering cognitive-behavioural interventions. The intervention is designed to be delivered over a 4-week period. The total time of the intervention is approximately 4 hours; this includes approximately 30-minute modules and 30-minute follow-up phone calls. Access to the online modules will be timed such that each module is released prior to the clinician-guided session. The purpose of the individual clinician follow-up phone sessions is to develop therapeutic alliance, review key concepts presented in the online modules, and guide discussion and patient self-reflection and action planning. A treatment manual developed for this intervention will be used to guide the follow up phone-calls by treating psychologists. The online modules include interactive activities such as completing their pain journey experience, short videos of patient experiences, education on the biopsychosocial model of pain and the role of medication use, behavioural monitoring, self-reflection such as exploring the benefits and downsides of current pain management strategies vs use of new strategies, goal setting and action planning, assessment of personality factors that may influence pain management and personalised coping skills training. An overview of the online modules includes: Module 1: Understanding the patient's pain journey Module 2: Education on the biopsychosocial model of pain Module 3: Exploring prescription opioid medication use and potential impacts Module 4: Identifying personalised coping strategies and implementing an action plan Module 1 aims to explore the patient's pain experience, key milestones in their journey including onset of pain and treatment experiences, explore their responses to the assessment questionnaires, provide psycho-education including the biopsychosocial model of pain and effectiveness of management strategies including opioid medications, and introduce self-monitoring, Module 2 aims to explore patient opioid medication use and contemplating change to their pain management using motivational interviewing techniques, goal setting and action planning. Module 3 aims to explore the patient's individual personality profile (e.g., depression-proneness) and practice coping skills techniques targeted to their factors. Patient's then will update their action plan to include coping skill techniques relevant for them. Module 4 aims to discuss relapse prevention, generalising skills, feedback of assessment results and any further plans for treatment or support beyond the research study (if required). Website analytics will be examined to ensure patient treatment uptake and adherence to the online modules as well as self-reported completion of the module components by patients during the clinician follow up sessions. A clinician checklist will also be completed after each follow up session to ensure adherence to the treatment manual.


Locations(2)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

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ACTRN12625000350426