Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000350426
Ethics application status
Approved
Date submitted
8/04/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the feasibility of a new brief psychological intervention for people living with chronic pain who use prescription opioid medications
Scientific title
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
Secondary ID [1] 314127 0
None
Universal Trial Number (UTN)
Trial acronym
OMED Assist (Opioid medication assistance)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic non-cancer pain 336933 0
Prescription opioid misuse 336934 0
Condition category
Condition code
Anaesthesiology 333401 333401 0 0
Pain management
Mental Health 333402 333402 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330712 0
Early detection / Screening
Intervention code [2] 330713 0
Behaviour
Intervention code [3] 330714 0
Treatment: Other
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340975 0
Feasibility of the intervention in practice including recruitment rates, intervention uptake and acceptability, and retention. This will be assessed as a composite outcome.
Timepoint [1] 340975 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.
Secondary outcome [1] 445665 0
Pain intensity level
Timepoint [1] 445665 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.
Secondary outcome [2] 445715 0
Depressive symptoms
Timepoint [2] 445715 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.
Secondary outcome [3] 445716 0
Current prescription opioid use
Timepoint [3] 445716 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.
Secondary outcome [4] 445721 0
Medication self-efficacy
Timepoint [4] 445721 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.
Secondary outcome [5] 445722 0
Pain disability
Timepoint [5] 445722 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.
Secondary outcome [6] 445723 0
Pain self-efficacy
Timepoint [6] 445723 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.
Secondary outcome [7] 445724 0
Emotional, psychological, and social well-being assessed as a composite score.
Timepoint [7] 445724 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.
Secondary outcome [8] 445725 0
Perceived level of comfort
Timepoint [8] 445725 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.
Secondary outcome [9] 445726 0
Qualitative evaluation of experience of the OMED Assist intervention.
Timepoint [9] 445726 0
3-months post-completion of the 4-week intervention.
Secondary outcome [10] 446329 0
Anxiety symptoms
Timepoint [10] 446329 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.
Secondary outcome [11] 446330 0
Stress symptoms
Timepoint [11] 446330 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.
Secondary outcome [12] 446331 0
Pain interference
Timepoint [12] 446331 0
Baseline, post-completion of 4-week intervention, 3, 6 and 12 months post-baseline.

Eligibility
Key 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 > 9)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Feasibility outcomes, patient acceptability and experience of the interventions will be summarised using descriptive statistics. Preliminary reliable change analyses will be calculated based on patients pre- to post-treatment/follow-up change in levels of pain intensity and opioid use; and other secondary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2025
Actual
Date of last participant enrolment
Anticipated
28/11/2025
Actual
Date of last data collection
Anticipated
18/12/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27699 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 27700 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 43890 0
4029 - Herston
Recruitment postcode(s) [2] 43891 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 318635 0
Hospital
Name [1] 318635 0
Metro South Health
Country [1] 318635 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 321108 0
None
Name [1] 321108 0
Address [1] 321108 0
Country [1] 321108 0
Other collaborator category [1] 283469 0
Hospital
Name [1] 283469 0
Princess Alexandra Hospital Pain Clinic, Metro South Health
Address [1] 283469 0
Country [1] 283469 0
Australia
Other collaborator category [2] 283470 0
Hospital
Name [2] 283470 0
Royal Brisbane and Women's Hospital Tess Cramond Pain and Research Centre
Address [2] 283470 0
Country [2] 283470 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317240 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317240 0
Ethics committee country [1] 317240 0
Australia
Date submitted for ethics approval [1] 317240 0
Approval date [1] 317240 0
24/03/2025
Ethics approval number [1] 317240 0
AM/2025/QMS/85753
Ethics committee name [2] 317241 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [2] 317241 0
Ethics committee country [2] 317241 0
Australia
Date submitted for ethics approval [2] 317241 0
Approval date [2] 317241 0
24/03/2025
Ethics approval number [2] 317241 0
Ethics committee name [3] 317243 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [3] 317243 0
Ethics committee country [3] 317243 0
Australia
Date submitted for ethics approval [3] 317243 0
15/04/2025
Approval date [3] 317243 0
Ethics approval number [3] 317243 0
2025/HE000817
Ethics committee name [4] 317261 0
University of the Sunshine Coast Human Research Ethics Committee
Ethics committee address [4] 317261 0
Ethics committee country [4] 317261 0
Australia
Date submitted for ethics approval [4] 317261 0
29/03/2025
Approval date [4] 317261 0
03/04/2025
Ethics approval number [4] 317261 0
S252071

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140446 0
Dr Rachel Elphinston
Address 140446 0
RECOVER Injury Research Centre The University of Queensland Level 7, Surgical Treatment and Rehabilitation Service 296 Herston Road HERSTON QLD 4029
Country 140446 0
Australia
Phone 140446 0
+61 412662084
Fax 140446 0
Email 140446 0
[email protected]
Contact person for public queries
Name 140447 0
Rachel Elphinston
Address 140447 0
RECOVER Injury Research Centre The University of Queensland Level 7, Surgical Treatment and Rehabilitation Service 296 Herston Road HERSTON QLD 4029
Country 140447 0
Australia
Phone 140447 0
+61 412662084
Fax 140447 0
Email 140447 0
[email protected]
Contact person for scientific queries
Name 140448 0
Rachel Elphinston
Address 140448 0
RECOVER Injury Research Centre The University of Queensland Level 7, Surgical Treatment and Rehabilitation Service 296 Herston Road HERSTON QLD 4029
Country 140448 0
Australia
Phone 140448 0
+61 412662084
Fax 140448 0
Email 140448 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.