Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000985482
Ethics application status
Approved
Date submitted
1/08/2025
Date registered
5/09/2025
Date last updated
5/09/2025
Date data sharing statement initially provided
5/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the Feasibility of Integrating Measurement Based Care into Group Therapy for Alcohol and Other Drug use using the 'Collect Share Act' Framework.
Scientific title
Integrating Measurement Based Care into Group Therapy for Alcohol and Other Substance Use using the Collect Share Act Framework: Protocol for a Randomised Feasibility Study
Secondary ID [1] 314989 0
Nil Known
Universal Trial Number (UTN)
U1111-1325-8473
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorders 338315 0
Substance Use Disorders 338684 0
Condition category
Condition code
Mental Health 334605 334605 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Measurement Based Care

Services allocated to the intervention arm will add measurement based care (outcome monitoring and feedback per the 'Collect Share Act' framework) to their routine delivery of community based group therapy sessions. This will involve the routine administration of outcome measures (‘collect’), and then using this data to a) provide clients with progress feedback (‘share’) and b) inform treatment planning (‘act’).

Group Therapy Sessions
Measurement based care will be integrated into the delivery of the following community-based group therapy programs. ‘Our Recovery Journey’ is a ten-session manualised group therapy program delivered across two modules. Module one groups are run in a weekly, rolling, open format with eligible participants welcome to join at any point in the cycle. This module comprises four 1.5hr groups and is designed to encourage people to reflect on their use of alcohol and other substances, help them to set goals and develop a personalized recovery plan. Following completion of Module One, participants are eligible for Module Two, which comprises six 2hr groups delivered weekly in a closed format. Module two focuses more on skills development to sustain recovery and prevent relapse. A six-session relapse prevention program is also available for people with previous experience of treatment who require additional support. People do not need to have completed modules one or two to attend. This program is delivered in an open format across weekly 2-hr groups, with people welcome to join at any point. The relapse prevention program is designed to support participants to reflect on their recovery journey, with a particular focus on early signs of lapse/ relapse to inform the development of a relapse prevention plan and emergency plan for crisis situations. Groups are available face-to-face and online. Group size is dependent on participant attendance. All groups are run by a trained facilitator, with one co-facilitator where possible (i.e. dependent on resourcing).

Outcome monitoring (Collect)

Following participants first scheduled group therapy session, they will receive weekly invitations (over 12-weeks) to complete a brief questionnaire (‘check-in’) in the 24-hour window before their weekly group session is scheduled to be delivered. Invitations will be sent automatically each week via text message or email (based on client preference) using routine practice software (RediCASE, Smartsheet or Microsoft Forms). Up to two reminders will be sent each week. It is expected that the check-in questionnaire will take approximately five minutes to complete.

Feedback (Share & Act)
Aligned with recommendations by the International Consortium for Health Outcome Measurement, outcome monitoring and feedback will be multi-dimensional. the monitoring tool from the work of Hallgren et al. which reflects domains identified by clinician as clinically useful. This includes alcohol and substance use, craving, mental health, confidence in avoiding alcohol or substance use, therapeutic alliance and client goals.

Feedback from the above weekly ‘check-in’ questionnaire will be integrated into the routine delivery of ‘Our Recovery Journey’ and ‘Relapse Prevention’ outpatient group therapy sessions (over 12-weeks). Feedback will comprise written statements to encourage self-reflection/ build motivation (e.g. Keep setting and working towards realistic plans - notice the wins and allow yourself to learn from the challenges. What good things (no matter how small) have you noticed?); summaries of the domains/ items that show evidence of improvement/ staying the same/ deteriorating; participant scores and how they compare to severity ranges/ response categories and graphs depicting progress over time. The generation of feedback will be largely automated using formulas embedded into Microsoft Forms, and supported by the research team as needed. Written feedback will be disseminated to participants (via email or hardcopy) in time for their next group (ideally within the 24-hours before the scheduled group). At the beginning of every group, clinicians will be asked to spend 5-10 minutes discussing the feedback with clients and to adapt their treatment protocol as needed. The steps include:
1. Invite participants to discuss outcome feedback at the start of every group session
2. Ask participants if the results match their own perception of progress, and prompt as needed
2a. Encourage participants to identify signs of progress (and what might be contributing)
2b. Encourage participants to identify signs of deterioration (and what might be contributing)
3. Use the discussion to develop a plan to consolidate change and address obstacles
4. Use the feedback to see if the plan is working, or needs to be adapted
5. Prioritise discussing not-on-track clients in individual sessions/ supervision

Providers
The intervention will be delivered by experienced community drug and alcohol workers already employed by the service. Up to 20 clinicians will be involved in delivering the intervention (dependent on who is responsible for delivering the included group therapy sessions)

Training
Clinicians will be trained in study procedures and the interpretation and discussion of feedback in two half-day workshops held within 2-weeks prior to implementation of the intervention. To maximise learning training will comprise a combination of best practice methods for training healthcare professionals including education, modelling, role-play, self-reflection and feedback from both peers and trainers. The workshop will be co-facilitated by the research team and a ‘champion’ identified by the service. To promote scalability, the training materials will rely heavily on free, publicly available materials. As a one-off workshop is insufficient to promote sustained change in clinician behaviour, ongoing support will be provided in the form of regular coaching (fortnightly for one month, monthly thereafter) to identify and troubleshoot implementation problems. The agenda of these sessions will be driven by the participating clinicians with a focus on shared learning by discussing successes, problem solving challenges and addressing questions.

Fidelity
Adherence to feedback practices will be assessed weekly via clinician self-report. Findings will be fed back to the service and discussed during supervision/ coaching sessions to promote adherence.
Intervention code [1] 331580 0
Behaviour
Comparator / control treatment
Treatment as Usual

Group Therapy Sessions
Participants will attend routinely delivered community based group therapy sessions. ‘Our Recovery Journey’ is a ten-session manualised group therapy program delivered across two modules. Module one groups are run in a weekly, rolling, open format with eligible participants welcome to join at any point in the cycle. This module comprises four 1.5hr groups and is designed to encourage people to reflect on their use of alcohol and other substances, help them to set goals and develop a personalized recovery plan. Following completion of Module One, participants are eligible for Module Two, which comprises six 2hr groups delivered weekly in a closed format. Module two focuses more on skills development to sustain recovery and prevent relapse. A six-session relapse prevention program is also available for people with previous experience of treatment who require additional support. People do not need to have completed modules one or two to attend. This program is delivered in an open format across weekly 2-hr groups, with people welcome to join at any point. The relapse prevention program is designed to support participants to reflect on their recovery journey, with a particular focus on early signs of lapse/ relapse to inform the development of a relapse prevention plan and emergency plan for crisis situations. All groups are delivered face-to-face.

Providers
Treatment as usual will be delivered by experienced community drug and alcohol workers already employed by the service. Up to 20 clinicians will be involved in delivering the groups in the comparator condition (dependent on who is responsible for delivering the included group therapy sessions)
Control group
Active

Outcomes
Primary outcome [1] 342285 0
Adherence to 'Collect' phase of 'Collect, Share, Act'. Operationalised as client adherence to weekly outcome monitoring schedule (number of weekly check-in questionnaires submitted expressed as a proportion of the number of check-in questions distributed)
Timepoint [1] 342285 0
12-weeks post first scheduled group therapy session
Primary outcome [2] 342286 0
Adherence to 'Share' phase of 'Collect, Share, Act'. Operationalised as facilitator adherence to in-group discussion of feedback (number of groups endorsed 'yes' by the participant, expressed as a proportion of the number of groups attended)
Timepoint [2] 342286 0
12-weeks post first scheduled group therapy session
Primary outcome [3] 342287 0
Adherence to 'Act' phase of 'Collect, Share, Act'. Operationalised as facilitator/ staff adherence to using feedback to inform treatment planning (number of weeks endorsed 'yes' by the participant, expressed as a proportion of the number of feedback reports generated)
Timepoint [3] 342287 0
12-weeks post first scheduled group therapy session
Secondary outcome [1] 450529 0
Experience of Care: Collaborative Decision Making (primary experience of care outcome). If ceiling effects are detected we will use top score analysis instead of Total score - i.e. the % of people responding with the highest possible score on all three items vs all others.
Timepoint [1] 450529 0
4-weeks (primary timepoint) and 12-weeks post first scheduled group therapy session
Secondary outcome [2] 450530 0
Experience of Care: Empowerment (total score; primary experience of care outcome)
Timepoint [2] 450530 0
4-weeks (primary timepoint) and 12-weeks post first scheduled group therapy session
Secondary outcome [3] 450531 0
Experience of Care: Satisfaction (primary experience of care outcome). If ceiling effects are detected we will use top score analysis instead of Total score - i.e. the % of people endorsing the top two highest categories vs all others.
Timepoint [3] 450531 0
4-weeks (primary timepoint) and 12-weeks post first scheduled group therapy session
Secondary outcome [4] 450533 0
Treatment Engagement: Total number of groups attended across the 12-week study period.
Timepoint [4] 450533 0
12-weeks post first scheduled group therapy session
Secondary outcome [5] 450534 0
Preliminary Effectiveness: Global impression of change (primary effectiveness outcome)
Timepoint [5] 450534 0
4-weeks (primary timepoint) and 12-weeks post first scheduled group therapy session
Secondary outcome [6] 450535 0
Preliminary Effectiveness: Psychological Health (total score; primary effectiveness outcome)
Timepoint [6] 450535 0
Baseline and at 4-weeks (primary timepoint) and 12-weeks post first scheduled group therapy session
Secondary outcome [7] 450537 0
Preliminary Effectiveness: Quality of Life (total score; primary effectiveness outcome)
Timepoint [7] 450537 0
Baseline and at 4-weeks (primary timepoint) and 12-weeks post first scheduled group therapy session
Secondary outcome [8] 450540 0
Preliminary Effectiveness: Days of use of primary substance of concern (total over the preceding 28-days; primary effectiveness outcome)
Timepoint [8] 450540 0
Baseline and at 4-weeks (primary timepoint) and 12-weeks post first scheduled group therapy session
Secondary outcome [9] 451559 0
Preliminary Effectiveness: Health Literacy (total score) as assessed by The Single Item Literacy Screener
Timepoint [9] 451559 0
Baseline and 12-weeks post first scheduled group therapy session
Secondary outcome [10] 451560 0
Preliminary effectiveness: Feeling understood and supported by healthcare providers as assessed by domain one of The Health Literacy Questionnaire
Timepoint [10] 451560 0
Baseline and 12-weeks post first scheduled group therapy session
Secondary outcome [11] 451561 0
Acceptability of measurement based care practices
Timepoint [11] 451561 0
12-weeks post first scheduled group therapy session

Eligibility
Key inclusion criteria
Presenting for a new episode of treatment for their own alcohol or other drug use and invited by the service to participate in one of the included group-therapy programs as part of their treatment plan.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients who attend less than two group therapy sessions will be excluded from the analysis. Following the guidance of a published trial of routine outcome monitoring (ROM) and feedback, this criterion was adopted as a minimum of two sessions are required to generate progress feedback (i.e. feedback after a single session reflects baseline symptom severity).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table generated using the 'random number' function in Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A statistical analysis plan is being developed. Trial registration will be updated prior to analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/10/2025
Actual
Date of last participant enrolment
Anticipated
16/03/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319539 0
Government body
Name [1] 319539 0
National Health and Medical Research Council (Meaningful Outcomes in Substance Use Treatment Centre of Research Excellence)
Country [1] 319539 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 322112 0
None
Name [1] 322112 0
Address [1] 322112 0
Country [1] 322112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318116 0
University of Wollongong Health and Medical Human Research Ethics Committee
Ethics committee address [1] 318116 0
Ethics committee country [1] 318116 0
Australia
Date submitted for ethics approval [1] 318116 0
13/05/2025
Approval date [1] 318116 0
30/06/2025
Ethics approval number [1] 318116 0
2025/136

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

Contacts
Principal investigator
Name 143162 0
Dr Alison Beck
Address 143162 0
School of Psychology, Northfields Ave, University of Wollongong, Wollongong, NSW 2522 Australia
Country 143162 0
Australia
Phone 143162 0
+61 1300275869
Fax 143162 0
Email 143162 0
[email protected]
Contact person for public queries
Name 143163 0
Alison Beck
Address 143163 0
School of Psychology, Northfields Ave, University of Wollongong, Wollongong, NSW 2522 Australia
Country 143163 0
Australia
Phone 143163 0
+61 1300275869
Fax 143163 0
Email 143163 0
[email protected]
Contact person for scientific queries
Name 143164 0
Alison Beck
Address 143164 0
School of Psychology, Northfields Ave, University of Wollongong, Wollongong, NSW 2522 Australia
Country 143164 0
Australia
Phone 143164 0
+61 1300275869
Fax 143164 0
Email 143164 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Sensitive and health data from a vulnerable population.



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.