Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001261606
Ethics application status
Approved
Date submitted
8/11/2023
Date registered
5/12/2023
Date last updated
18/08/2024
Date data sharing statement initially provided
5/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Program to Foster Motivation for Physical Activity Among Adults in Substance Use Recovery
Scientific title
A Group Motivational Intervention to Support Physical Activity Motivation and Maintenance among Adults in Residential Treatment for Substance Use Disorders: A N-of-1 Study
Secondary ID [1] 310802 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance Use Disorder 331785 0
Condition category
Condition code
Mental Health 328524 328524 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Motivational intervention

WHY:
Individuals dealing with substance use disorders (SUDs) might benefit from becoming more physically active and sustaining physical activity (PA) throughout their lives. Nevertheless, the challenge of sustaining motivation for continuous, long-term physical activity is a concern among this population.

WHAT:
The motivational intervention is based on principles of Motivational Interviewing (MI) for a support group context. The motivational intervention was co-designed to incorporate specific behaviour change techniques (BCTs) that have been found effective in physical activity interventions in SUD contexts and match MI techniques. Short bursts (1-2min) of low to moderate-intensity PA will be included in the group sessions, as well. Low-to-moderate physical activity will not be assessed, but the types of activity engaged in (e.g., stretching, walking around the room and balloon volleyball) will be the equivalent of those likely to be considered light to moderately hard on the Borg Rate of Perceived Exertion (RPE) scale. Further, participants will engage in self-monitoring their daily step counts and recording them alongside other daily measures. Men participating in the study will receive a short presentation outlining the study to them and a Fitbit activity monitoring device.

WHO AND HOW:
All intervention sessions will be delivered face-to-face by a psychologist with a master’s degree in clinical psychology, training in group counselling and MI, and more than two years of experience. Group interventions will take place in groups of 12 men.

WHERE:
The motivational intervention will be delivered in a treatment facility providing treatment for alcohol and other drug (AOD) related issues in the greater Perth region in Western Australia. The treatment facility will provide suitable rooms for individual and group sessions.

WHEN AND HOW MUCH:
The intervention commences after the baseline phase. The structured motivational intervention program consists of 12 60-minute sessions including an initial one-on-one counselling session (intervention phase), 9 subsequent weekly group sessions (intervention phase), and two individual counselling booster sessions 4 weeks apart (maintenance phase). The first individual session will be a pre-group meeting aiming to get to know the participants and to familiarise them with the MI communication style. The group sessions will cover the four phases of MI in group settings, i.e., engaging the group, exploring perspectives, broadening perspectives, moving into action. Group session content covers discussions around the benefits of PA, motivation and goal setting for PA, exploring lifestyle and habits, exploring ambivalence and core values, exploring personal strengths and creating personal change plans. During the individual booster sessions, change plans will be revisited and revised. The first booster session takes place four weeks after the last group session (the maintenance phase starts after the last group session).

TAILORING:
The intervention is designed in accordance with established principles of MI for group settings, with specific modifications tailored for the purpose of promoting PA maintenance among individuals with SUDs. Participants receive assistance in their efforts to change behaviour, both from the intervention itself and from their fellow participants. Additionally, each participant is provided support by either a personal trainer or an exercise physiologist to develop and adjust personalized plans for behavioural change. During subsequent follow-up sessions, participants receive feedback concerning their unique goals, and adjustments to their change plans are made to better align with individual and situational requirements.

HOW WELL:
Attendance to the motivational intervention sessions will be recorded by the facilitator.
Intervention code [1] 327221 0
Behaviour
Comparator / control treatment
Active control group. Individual changes will be compared against baseline measures. During the baseline period, participants follow the treatment as usual in the treatment facility and receive no additional instructions. Treatment as usual includes a structured physical activity program consisting of a 30-minute walk four times a week, a 60-minute yoga session one time a week, a 60-minute boxercise session one time a week, and a 60-minute bootcamp session one time a week. Additionally, individual and group counselling, engagement in 12-step groups, psychoeducation groups, mindfulness groups, support work, and equine therapy are part of the treatment as usual. The baseline duration will be unique to each participant, ranging from two to six weeks, depending on the date they commence treatment at the treatment facility.
Control group
Active

Outcomes
Primary outcome [1] 336354 0
Changes in the quality of motivation for physical activity
Timepoint [1] 336354 0
Assessed daily for 28 weeks across all study phases including:
- Baseline phase (weeks 0 – 6)
- Intervention phase (weeks 6 – 16)
- Maintenance phase (weeks 16 – 28)
Secondary outcome [1] 427980 0
Changes in affect
Timepoint [1] 427980 0
Assessed daily for 28 weeks across all study phases including:
- Baseline phase (weeks 0 – 6)
- Intervention phase (weeks 6 – 16)
- Maintenance phase (weeks 16 – 28)
Secondary outcome [2] 427981 0
Changes in craving for substance use
Timepoint [2] 427981 0
Assessed daily for 28 weeks across all study phases including:
- Baseline phase (weeks 0 – 6)
- Intervention phase (weeks 6 – 16)
- Maintenance phase (weeks 16 – 28)
Secondary outcome [3] 427982 0
Changes in physical activity
Timepoint [3] 427982 0
Assessed daily for 28 weeks across all study phases including:
- Baseline phase (weeks 0 – 6)
- Intervention phase (weeks 6 – 16)
- Maintenance phase (weeks 16 – 28)
Secondary outcome [4] 427983 0
Intervention feasibility and acceptability as a composite outcome
Timepoint [4] 427983 0
End of intervention phase, 16 weeks after baseline

Eligibility
Key inclusion criteria
All residents of the treatment facility will be able to participate in the study if they can enroll at least 2 weeks prior to the start date of the intervention phase. Individuals are eligible for treatment at the facility if they:
1. are male
2. are >= 18 years old
3. have a diagnosis for substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5th ed.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will not be admitted to the treatment facility if they:
1. have co-morbid psychiatric diagnoses other than depressive disorders, anxiety disorders, post-traumatic stress disorders, borderline personality disorder, psychosis, schizophrenia, and bipolar disorder
2. experienced acute relapse in symptoms of a diagnosed mental illness (such as schizophrenia) within the past 3 months, and/or they are not taking the correct medication
3. have got cognitive or physiological dysfunctions that may interfere with capacity to engage in therapy
4. are undergoing gender-affirming treatments
5. have got upcoming legal issues that may result in prison time
6. fail to disclose any criminal history or legal matters
7. have got a history of sex crimes
8. have got a history of arson
9. evidence signs of intoxication

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
Other
Other design features
A non-concurrent multiple baseline N-of-1 design using ABC (A-baseline, B-Treatment, C-maintenance) procedure. All participants will act as their own control prior to receiving the intervention.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
In this study we will employ a non-concurrent multiple-baseline N-of-1 (also referred to as a single-case design) ABC intervention withdrawal design. Data will be gathered daily throughout the entire 28-week study period. Each participant's data will be treated as a unique dataset and subjected to individualised analysis. In cases where data is missing, we will employ bootstrapping techniques for imputation. Imputation will be conducted separately for each dataset and data series. The effects of the imputation on the accuracy and validity of the predictions will be assessed, as well. Participant data will be retained in the analysis if they have at least two weeks of baseline data, 10 weeks of data during the intervention phase, and at least 8 weeks of data from the maintenance phase.

We will plot and visually inspect the trajectories of all variables across participants and study phases. Non-overlap methods will be utilized to evaluate the degree of change in observations during the intervention and maintenance phases when compared to the baseline phase. Subsequently, randomisation tests will be employed with the non-overlap methods to derive randomization distributions (nonoverlap percentages) and p-values. Additionally, a piecewise regression model and a generalised logistic approach will be employed to model linear trends and to explore non-linear trends for various phases of the intervention, providing confidence bands.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/12/2023
Actual
15/12/2023
Date of last participant enrolment
Anticipated
10/01/2024
Actual
5/04/2024
Date of last data collection
Anticipated
21/07/2024
Actual
15/04/2024
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315039 0
University
Name [1] 315039 0
Curtin University Faculty of Health Sciences Strategic Project 2020 Scholarship
Country [1] 315039 0
Australia
Primary sponsor type
Individual
Name
A/Prof Eleanor Quested
Address
GPO Box U1987 Perth WA 6845
Country
Australia
Secondary sponsor category [1] 317062 0
None
Name [1] 317062 0
Address [1] 317062 0
Country [1] 317062 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314000 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 314000 0
Ethics committee country [1] 314000 0
Australia
Date submitted for ethics approval [1] 314000 0
22/08/2023
Approval date [1] 314000 0
26/09/2023
Ethics approval number [1] 314000 0
HRE2023-0544

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

Contacts
Principal investigator
Name 130078 0
A/Prof Eleanor Quested
Address 130078 0
Curtin School of Population Health, Curtin University, GPO Box U1987 Perth WA 6845
Country 130078 0
Australia
Phone 130078 0
+61 8 9266 5693
Fax 130078 0
Email 130078 0
[email protected]
Contact person for public queries
Name 130079 0
Eleanor Quested
Address 130079 0
Curtin School of Population Health, Curtin University, GPO Box U1987 Perth WA 6845
Country 130079 0
Australia
Phone 130079 0
+61 8 9266 5693
Fax 130079 0
Email 130079 0
[email protected]
Contact person for scientific queries
Name 130080 0
Eleanor Quested
Address 130080 0
Curtin School of Population Health, Curtin University, GPO Box U1987 Perth WA 6845
Country 130080 0
Australia
Phone 130080 0
+61 8 9266 5693
Fax 130080 0
Email 130080 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.