Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000132448
Ethics application status
Approved
Date submitted
14/01/2025
Date registered
6/02/2025
Date last updated
18/06/2025
Date data sharing statement initially provided
6/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Groups for Belonging: a group-based loneliness intervention for people attending treatment for alcohol and other drug use
Scientific title
Groups for Belonging: A parallel Cluster Randomised Controlled Trial of a group-based loneliness intervention for people attending treatment for alcohol and other drug use
Secondary ID [1] 313626 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use 336184 0
Drug use 336389 0
Condition category
Condition code
Mental Health 332721 332721 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 (Treatment): Groups for Belonging

Groups for Belonging (G4B) is a group-based, theory-informed loneliness intervention for people accessing alcohol and other drug (AOD) treatment, G4B involves 6 x 2-hour sessions delivered over a 4 to 6-week period, with intervention length dependant upon the length of the program offered by respective AOD treatment sites. Sessions of G4B explore the following themes across sessions:

Session 1. Session 1 explores the relationship between loneliness, substance use, and health. This session uses activities and discussions to develop participants’ understanding of how and why their relationship with others is important to their health, wellbeing, and treatment goals. Out of session practice involves monitoring episodes of loneliness in preparation for Session 2.

Session 2. The theme of session 2 is managing loneliness, and mapping the social world. In session 2, participants engage in activities where they learn strategies to manage loneliness, and start to work through what their social world currently looks like via a social identity mapping exercise. Participants are encouraged to review this social identity map to further consider their current social groups as personal practice (i.e., homework).

Session 3. Session 3 focusses on the theme of valued relationships. Participants in session 3 navigate how their personal principles and values might help them seek out meaningful relationships with others, particularly those that are supportive of their treatment goals. Activities involve introducing participants to the notion of values, how social groups may or may not reflect personal values, and strategies for managing difficult feelings, such as mindfulness work. Mindfulness practice is encouraged as personal practice and developed further in Session 4.

Session 4. Session 4 centres around stigma and reconnecting with groups participants previously engaged with. Through activities and discussions, participants are encouraged to work through the barriers they may be facing in connecting with others (e.g., stigma), and strategies they may implement to overcome these barriers, including mindfulness and managing set backs. Attempts to reconnect and further mindfulness practice are set as personal practice tasks.

Session 5. Session 5 centres on building social connections, and leads on from session 4 by working with participants to develop strategies for meeting new people and groups that foster belonging. Activities centre around the development of strategies to join new social groups, goal setting, and navigating barriers to achieving social goals. Participants are encouraged to take steps towards social goals as personal practice.

Session 6. Session 6 wraps up Groups for Belonging with a focus on maintaining progress. The core outcome of this session is working with participants to take what they have learned in Groups for Belonging to the outside world. Participants are guided through discussions that focus on overcoming barriers to connecting, including mistrust, and fear of showing feelings. Next steps are provided, with encouragement to continue to work towards social goals to combat loneliness, and build their personal sense of belonging.

Groups for Belonging will run as a face-to-face closed group, delivered within the site where the consumers are currently attending treatment, with membership fixed at the beginning of each iteration of the intervention (n sites = 13 sites randomised to the treatment condition, stratified by service type (residential/day program). Multiple iterations of Groups for Belonging will run at each site. The number of iterations, and the number of people within iterations at each site will depend on the capacity of the site; however, it is intended that there will be approximately 10 people per group, and two-iterations of Groups for Belonging per site (n = 20 people per site). The intervention is manual guided, including a client workbook and a facilitators manual. The manual and client workbook were specifically designed for this intervention. Groups for Belonging will be facilitated by an experienced clinician employed by The University of Wollongong and co-facilitated by a staff member employed at the treatment site. Treatment completion is defined as missing no more than two consecutive weeks, and where catch-up work was completed. Catch-up work is defined as a research clinician facilitated ‘make-up session’ that will be held 45 minutes prior to the next session of Groups for Belonging. While attendance is voluntary, participants will be made aware that regular attendance of sessions is likely to result in them getting the most out of the Groups for Belonging program.

To monitor fidelity to the intervention, staff involved in delivery of Groups for Belonging will complete formal training and weekly supervision led by clinical psychologists (investigators, II and GD). Training and monthly supervision will also be provided (by AB) to an independent Fidelity Assessor, who will be based at the University of Wollongong. All intervention sessions will be audio-taped in order to rate fidelity to the intervention. The trained Fidelity Assessor will rate a random allocation of 20% of treatment sessions (stratified by session and trial site) for adherence to intervention content and competence in intervention delivery. Intra-rater reliability procedures will be conducted with 20% of the fidelity-assessed treatment sessions to ensure consistency of fidelity assessor ratings of each session.

A subset of 10 participants across sites who have participated in G4B will be recruited to complete a 30 minute semi-structured qualitative interview about their experience with G4B. Participants will be asked what works well, what does not work well, and what could be improved in future.
Intervention code [1] 330220 0
Treatment: Other
Comparator / control treatment
Arm 2 (Control): Treatment as Usual

Treatment as usual will be the comparator against which the effectiveness of Groups for Belonging is measured. For the purpose of this trial, treatment as usual comprises the programs offered within trial sites, and the subsidiary supports that a consumer participant engages in as part of their individual treatment. Trial sites are specialised AOD treatment services that potential participants are already attending prior to consenting to participate in the current trial. This will include both (1) outpatient programs and (2) residential rehabilitation services.

1. Community based outpatient services that typically include group and individual support focused on the person’s substance use and other associated concerns (e.g. mental health, lifestyle). For the current study, the program will need to be at least 5 - 7 weeks in length.

2. Residential Rehabilitation Treatment Services are structured, residential programs typically offering live-in educational group programs, individual supports, and the provision of lifestyle skills training. For the current study, the program will need to be at least 7-weeks in length.

13 treatment sites will be randomised to the control condition, stratified by service type (outpatient/residential program). We intended to recruit n = 20 participants per service (ntotal = 260 participants). Whilst there is variation in the way that outpatient and residential rehabilitation services operate, they include broadly consistent treatment practices. Recruiting participants from across different treatment providers will increase the ecological validity of our findings and provide evidence on the effectiveness of Groups for Belonging in real-world settings that reflect the diversity of people who access AOD treatment, and the services within which they access treatment.

A subset of 10 participants across sites who have participated in the control arm of this trial will be recruited to complete a 30 minute semi-structured qualitative interview about their experience with treatment as usual. Participants will be asked what works well, what does not work well, and what could be improved in future.
Control group
Active

Outcomes
Primary outcome [1] 340251 0
Loneliness
Timepoint [1] 340251 0
Baseline, 7-weeks post-baseline, and 6-months post-intervention completion (primary endpoint).
Secondary outcome [1] 443479 0
Days of substance use
Timepoint [1] 443479 0
Baseline, 7-weeks post-baseline, and 6-months post-intervention completion.
Secondary outcome [2] 443480 0
Cravings
Timepoint [2] 443480 0
Baseline, 7-weeks post-baseline, and 6-months post-intervention completion.
Secondary outcome [3] 443481 0
Group membership
Timepoint [3] 443481 0
Baseline, 7-weeks post-baseline, and 6-months post-intervention completion.
Secondary outcome [4] 443482 0
Psychological Distress
Timepoint [4] 443482 0
Baseline, 7-weeks post-baseline, and 6-months post-intervention completion.
Secondary outcome [5] 443483 0
Quality of Life Years Adjusted
Timepoint [5] 443483 0
Baseline and 6-months post-intervention completion.
Secondary outcome [6] 443484 0
Service Use
Timepoint [6] 443484 0
Baseline and 6-months post-intervention completion.

Eligibility
Key inclusion criteria
The following eligibility criteria for client participants will be applied:
- An adult (18+) accessing treatment for alcohol and other drug use (i.e., not for gambling).
- Current interest in improving connectedness, as indicated by a single item on the recruitment screening form.
- Intention to remain in the services’ community or residential program for the duration of the intervention period (5-7 weeks).
- Access to a mobile telephone to complete follow-up assessments.

In addition to the above inclusion criteria, participants interested in the qualitative component of the study will:
- Be willing to have their interview audio-recorded
- And those participants who are attending a site in the treatment arm will be required to:
- Have completed the Groups for Belonging Program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following exclusion criteria will be applied:
- Currently experiencing acute suicidality or unstable mental health symptoms

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 was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by service type (residential/outpatient) to ensure a balanced proportion of service types across the study arms. Block randomisation will be utilised – employing permuted block sizes of 2 (community services) and 4 (residential services) to help ensure that an equal number of services within each strata are assigned to the control and intervention arms. Small block sizes are being utilised due to the likelihood of smaller site numbers within the community sites strata. The best treatment group balance is achieved with the smallest block size (Shum & Hamilton, 2016). Sites will be assigned to blocks in this manner until saturation (i.e, 13 treatment sites; 13 control sites).
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
Efficacy
Statistical methods / analysis
Sample Size

Quantitative Sample Size
A total of 520 participants will be recruited to the quantitative aspect of the trial through approved study sites. Study sites will be randomly allocated to either the treatment (Groups for Belonging + treatment as usual) or control (treatment as usual) conditions.

Qualitative Sample Size
Approximately 30 consumers and 10 staff members (depending on saturation) who have completed/ facilitated Groups for Belonging intervention will be recruited for semi-structured interviews from Treatment Condition sites (since interviews will focus on barriers and facilitators to implementation of Groups for Belonging). In addition, approximately 30 consumers and 10 staff members (depending on saturation) will be recruited from the Control Condition sites to understand their routine treatment experience.

Power calculations

Sample size calculations were performed using the STATA package ‘clustersampsi’ (Hemming & Marsh, 2013). The control mean loneliness score was assumed to be 49 (SD = 10), and intervention mean of 45 (SD = 10), based on findings reported across similar samples (Britton & et al., 2007; Kuerbis & et al., 2017) and indicators of significant and clinically meaningful change across more diverse samples (Applebaum & et al., 2019). Intra Cluster Correlation was assumed conservatively to be 0.05. It was calculated that 13 clusters per arm, with 20 participants recruited per cluster, would have 81% power and 5% type 1 error rate) to detect a difference in loneliness at 6 months of 4 points. A retention rate of 70% was assumed (i.e., of 20 participants recruited per cluster, follow-up would be available for at least 14. Our team have a demonstrated track record of achieving excellent follow-up rates across similar samples (e.g., 88% at 8-month follow-up for the Healthy Recovery Study; 77% at 6-month follow-up for Continuing Care project (Kelly et al., 2020; 2021). To ensure statistical power, our sample size calculation is based on a conservative estimate of 70% follow-up.

Data Analysis

Quantitative analysis
Statistical analyses will be managed by independent statisticians based the Hunter Medical Research Institute. Loneliness scores will be analysed using linear regression in a mixed modelling framework. Fixed effects will include terms for intervention, time point (7 weeks or 6 months), an interaction between intervention and time point, baseline loneliness score, and strata (inpatient vs residential), and random effects for cluster and participant will be included to account for clustering by site, and repeated measurements on participants. The estimated mean difference in loneliness scores between the arms at the primary (6 months) and secondary (7 weeks and 6 months) time points will be reported, along with 95% Confidence intervals, and p-values, as summary measures of the intervention effectiveness. The analysis set for the primary outcome will be Intention to Treat (ITT). In the case of missing data, multiple imputation methods (under a MAR assumption) will be utilised to ensure the analysis set is (ITT). This means that the ITT estimate is able to be produced even when there is missing follow-up data. A tipping point analysis will also be employed to account for the likely substantial loss to follow-up within this cohort. Data will be imputed under the MNAR assumption (i.e., that those participants who have missing data are more likely to have worse outcomes). This method will allow us to determine how biased the non-missing data would need to be before it changed the study conclusions (Ratitch, O’Kelly, and Tosiello, 2013). In the event that an entire cluster (i.e. a study site) drops out of the study prior to participant recruitment, this site will be replaced to ensure adequate power. In this case, we will run a ‘modified-ITT’ which involves the analysis of all participants randomised, and all clusters with one or more participants. Analysis of secondary outcomes at 7 weeks and 6 months will also utilise linear mixed models (if assumptions of normally distributed residuals and constant variance are met), or generalised linear mixed models otherwise. Fixed effects will include those listed above for the primary outcome variable. Effect estimates for the difference between arms, 95% confidence intervals, and p-values, will be reported for each outcome at each follow-up time point. A sub-group analysis will be performed estimating the difference in change in loneliness from baseline among those participants who reported high loneliness scores at baseline. A secondary sub-group analysis comparing the difference in loneliness scores at 7 weeks and 6 months for residential participants compared to community-based participants will also be performed.

Qualitative analysis
Demographic and descriptive information will be synthesised using descriptive statistics. Qualitative zoom interviews will be recorded (with prior consent from participants) and audio recordings will be sent for transcription by a professional transcriber working under a confidentiality agreement. Data coding and analyses will be guided by Iterative Categorisation. Iterative categorisation is compatible with common analytical approaches (e.g. thematic analysis) and offers a clear, standardised guide for coding which allows for replication and validity in qualitative data analysis (Neale, 2016).

Economic analysis

A trial-based economic evaluation will be conducted from a health system perspective based on intention to treat. Resource use data associated with participation in the intervention, and treatment as usual will be prospectively identified, measured, and valued. Outcomes will be aligned to the primary clinical trial outcome – incremental change in loneliness as well as change in health-related quality of life, measured using the AQoL-8D to be transformed into incremental Quality Adjusted Life Years (QALY). Incremental cost-effectiveness ratios (ICERs) will be calculated by dividing the between-groups difference in costs by the between-group difference in effects. Uncertainty intervals around the ICERs will be estimated using non-parametric bootstrapping techniques and graphically presented on cost-effectiveness planes. Acceptability curves and net monetary benefit will also be calculated. Sensitivity analysis will test for variability in parameters such as unit costs and event likelihood. Given the expected longer-term impact of improving mental wellbeing among this population, a lifetime model will be specified and populated to understand the longer-term values of Groups for Belonging.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/02/2025
Actual
19/02/2025
Date of last participant enrolment
Anticipated
18/12/2026
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
540
Accrual to date
75
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC

Funding & Sponsors
Funding source category [1] 318095 0
Government body
Name [1] 318095 0
National Health and Medical Research Council
Country [1] 318095 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 320452 0
None
Name [1] 320452 0
Address [1] 320452 0
Country [1] 320452 0
Other collaborator category [1] 283335 0
University
Name [1] 283335 0
University of Queensland
Address [1] 283335 0
Country [1] 283335 0
Australia
Other collaborator category [2] 283336 0
University
Name [2] 283336 0
University of Newcastle
Address [2] 283336 0
Country [2] 283336 0
Australia
Other collaborator category [3] 283337 0
Government body
Name [3] 283337 0
NSW Ministry of Health Centre for Alcohol and Other Drugs
Address [3] 283337 0
Country [3] 283337 0
Australia
Other collaborator category [4] 283338 0
Other
Name [4] 283338 0
Network of Alcohol and Other Drug Agencies
Address [4] 283338 0
Country [4] 283338 0
Australia
Other collaborator category [5] 283339 0
Other
Name [5] 283339 0
Victorian Alcohol and Drug Association
Address [5] 283339 0
Country [5] 283339 0
Australia
Other collaborator category [6] 283340 0
Other
Name [6] 283340 0
Alcohol Tobacco and Other Drug Association ACT
Address [6] 283340 0
Country [6] 283340 0
Australia
Other collaborator category [7] 283341 0
Charities/Societies/Foundations
Name [7] 283341 0
Uniting Care Australia
Address [7] 283341 0
Country [7] 283341 0
Australia
Other collaborator category [8] 283342 0
Charities/Societies/Foundations
Name [8] 283342 0
Kadesh Rehabilitation Services
Address [8] 283342 0
Country [8] 283342 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316741 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316741 0
Ethics committee country [1] 316741 0
Australia
Date submitted for ethics approval [1] 316741 0
02/07/2024
Approval date [1] 316741 0
30/08/2024
Ethics approval number [1] 316741 0
Protocol no. X24-0169; REGIS Identifier 2024/ETH00914

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

Contacts
Principal investigator
Name 138862 0
Prof Peter Kelly
Address 138862 0
Building 67, Northfields Avenue, University of Wollongong NSW, Australia, 2522
Country 138862 0
Australia
Phone 138862 0
+61 2 4239 2382
Fax 138862 0
Email 138862 0
[email protected]
Contact person for public queries
Name 138863 0
Dr Isabella Ingram
Address 138863 0
Building 41.139, Northfields Avenue, University of Wollongong NSW, Australia, 2522
Country 138863 0
Australia
Phone 138863 0
+61 2 4221 4484
Fax 138863 0
Email 138863 0
[email protected]
Contact person for scientific queries
Name 138864 0
Dr Isabella Ingram
Address 138864 0
Building 41.139, Northfields Avenue, University of Wollongong NSW, Australia, 2522
Country 138864 0
Australia
Phone 138864 0
+61 2 4221 4484
Fax 138864 0
Email 138864 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.