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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000350426
Acronym
OMED Assist (Opioid medication assistance)
Enrollment
12
Registered
2025-04-23
Start date
2025-09-23
Completion date
2026-03-27
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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 provisio

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.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

- 18-70 years old - Medically diagnosed chronic non-cancer pain - Treatment seeking either from chronic non-cancer pain specialist services - Clinically significant pain measured as a current pain severity score of >4 or pain reported as clinically significant by the patient - At risk of prescription opioid misuse (opioid misuse risk [COMM] score >=6 )

Exclusion criteria

- Severely distressed assessed through administering Kessler Psychological Distress Scale (K6) and phone risk assessment - Non-english speaking - History of recent injecting drug use - Unable to read (low literacy skills) - No internet access if they cannot attend in-person

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026