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Trial registered on ANZCTR


Registration number
ACTRN12617001602314
Ethics application status
Approved
Date submitted
7/11/2017
Date registered
7/12/2017
Date last updated
7/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a new social intervention to increase community connectedness and reduce isolation in adults transitioning home after long term hospital care: The Groups 4 Health Trial
Scientific title
Effectiveness of a new social intervention to increase community connectedness and reduce psychological distress in adults transitioning home after long term hospital care: The Groups 4 Health trial.
Secondary ID [1] 293301 0
None
Universal Trial Number (UTN)
Trial acronym
G4H Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 305384 0
social anxiety 305385 0
Condition category
Condition code
Mental Health 304670 304670 0 0
Depression
Mental Health 304671 304671 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Groups 4 Health Trial:
G4H is a manualized program that seeks to increase social connectedness by building group-based social identifications in the context of an in-vivo group experience. The five modules give people the knowledge and skills they need to manage their social group memberships, and the identities that underpin them, effectively.

The intervention comprises 5 x 1.5 hour face-to-face group facilitated sessions, run weekly in the first month with the final module 5 delivered 1 month later. Modules 1-4 have associated homework after each session which takes about 30 minutes. The program is delivered in the Psychology Clinic of the School of Psychology, University of Queensland. Facilitators are Clinical and Health Psychology postgraduate students who receive training and weekly supervision to deliver the program.

Module content is summarised below.

Module 1: Schooling. Raises awareness of the beneficial effects that social group memberships have for health. It highlights the costs of ignoring the social dimensions of health and points out that failure to use all the social resources at our disposal generally leads to suboptimal health outcomes. The module also makes the point that it is within people’s power to counter these effects by learning how best to develop, maintain and harness group-based resources.

Module 2: Scoping. Focuses on the range of group-based resources that people have, or ideally should have at their disposal, to optimize health. This module engages participants in the process of social identity mapping (Cruwys, Steffens, Haslam, et al., 2015). This tool was developed to explore respondents’ social identities, in order to assess their current social functioning and develop a sense of how they would ideally like to function in the futureIdentifying current group memberships and any gaps in group networks.

Module 3: Sourcing. Targets development of skills needed to identify and strengthen existing valued social identities with a view to optimizing and sustaining these in the longer term. It also raises awareness of solutions to barriers to making the most of existing groups.

Module 4: Scaffolding. Uses the G4H group as a model for establishing and embedding new social group connections whilst at the same time exploring strategies to identify which connections to develop and enact through a social plan of action. The goal is to trial these social plans between this and the final module, which takes place at least one month later.

Module 5: Sustaining: Is a booster session held one month later that aims to troubleshoot any difficulties that have arisen in the course of implementing these social plans. It also revisits social identity maps, created in Module 2, to see how they have developed in the course of the program. The social foundations that have been identified and developed in the preceding four modules are also reviewed with a view to encouraging their long-term maintenance.

In addition to the facilitator manual, the program is supported by a client workbook. This contains a summarized version of the facilitator’s manual highlighting the main activities and learning points for each session, with sufficient space to complete activities (both within the sessions and as homework) and document any relevant notes and plans to achieve particular goals.

Treatment fidelity is assessed by brief questionnaire completed by facilitators at the end of each session delivered. This requires facilitators to tick off session activities covered, rate alliance and rapport between participants and with facilitator, indicate the length of session, and rate session satisfaction and ease of delivery.
Intervention code [1] 299559 0
Treatment: Other
Comparator / control treatment
Wait-list control commenced after 4 months
Control group
Active

Outcomes
Primary outcome [1] 303882 0
mean Roberts UCLA Loneliness Scale score
Timepoint [1] 303882 0
Baseline, on completion of G4H (primary endpoint), 2 months after completion of G4H
Secondary outcome [1] 340349 0
mean depression sub scale score from the Depression Anxiety and Stress Scale
Timepoint [1] 340349 0
baseline, on completion of G4H, 2 months after completion of G4H
Secondary outcome [2] 340350 0
Average rating on multiple group membership scale (published scale comprising 4 items)

Citation: Haslam, C., Holme, A., Haslam, S.A., Iyer, A., Jetten, J., & Williams, W.H. (2008). Maintaining group membership: Identity continuity and well-being after stroke Neuropsychological Rehabilitation, 18, 671-691
Timepoint [2] 340350 0
baseline, on completion of G4H, 2 months after completion of G4H
Secondary outcome [3] 340604 0
mean mini-SPIN
Timepoint [3] 340604 0
baseline, at completion of G4H, 2 months after completion of G4H
Secondary outcome [4] 340605 0
Number of general practitioner appointments in last month (self report)
Timepoint [4] 340605 0
baseline, at completion of G4H, 2 months after completion of G4H

Eligibility
Key inclusion criteria
1. Diagnosed with mental illness by health professional or
2. Scoring above the threshold (i.e., > 5) on the Patient Health Questionnaire - 9 (PHQ-9).
3. perceived social isolation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. known neurological condition
2. known history of psychosis
3. Unstable and fluctuating mental health condition that would interfere with taking part in a group program
4. severe learning impairment
5. non-English speaking

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)
Randomisation by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Wait list control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analyses were conducted based on the pre-post effect size for the primary outcome (loneliness) found in pilot data (d = 0.86; Haslam et al., 2016). This suggests a minimum of 23 participants would need to be retained in each condition at follow-up for 80% power (Lehr, 1992). Drawing on the retention data from pilot study (of 67%) aimed to recruit 65 participants in each condition at baseline

Analysis strategy:
Separate repeated measures ANOVA to assess the effect of intervention on primary and secondary outcomes, both with intention-to treat (where outcome data is estimated using carry forward of last available observations) and per protocol analyses (only including participants who met eligibility criteria, were randomly assigned, and completed the intervention according to the protocol, and had both baseline and follow-up data).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/04/2015
Date of last participant enrolment
Anticipated
Actual
20/02/2017
Date of last data collection
Anticipated
Actual
12/06/2017
Sample size
Target
130
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 18036 0
4072 - University Of Queensland
Recruitment postcode(s) [2] 18037 0
4068 - Taringa
Recruitment postcode(s) [3] 18038 0
4066 - Toowong
Recruitment postcode(s) [4] 18039 0
4101 - West End
Recruitment postcode(s) [5] 18040 0
4103 - Annerley
Recruitment postcode(s) [6] 18041 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 18042 0
4101 - South Brisbane
Recruitment postcode(s) [8] 18043 0
4068 - Indooroopilly
Recruitment postcode(s) [9] 18044 0
4169 - Kangaroo Point
Recruitment postcode(s) [10] 18045 0
4000 - Brisbane
Recruitment postcode(s) [11] 18046 0
4060 - Ashgrove
Recruitment postcode(s) [12] 18047 0
4064 - Paddington

Funding & Sponsors
Funding source category [1] 297926 0
University
Name [1] 297926 0
University of Queensland
Country [1] 297926 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
University of Qld, St Lucia, Qld, 4072
Country
Australia
Secondary sponsor category [1] 296988 0
None
Name [1] 296988 0
Address [1] 296988 0
Country [1] 296988 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298972 0
Behavioural and Social Sciences Ethical Research Committee
Ethics committee address [1] 298972 0
University of Qld, St Lucia, Qld, 4072
Ethics committee country [1] 298972 0
Australia
Date submitted for ethics approval [1] 298972 0
12/01/2015
Approval date [1] 298972 0
05/03/2015
Ethics approval number [1] 298972 0
2014000731

Summary
Brief summary
Social isolation is a major health risk and for many is associated with psychological distress. A new social group intervention, Groups 4 Health (G4H), has strong potential to address this problem. G4H is a five-module, manualized program that seeks to increase social connectedness by building group-based social identifications in the context of an in-vivo group experience. Its effectiveness has already demonstrated in a proof of-concept study (Haslam et al., 2016), but it has yet to be systematically trialled. This randomised controlled trial of G4H will recruit 130 adults presenting with psychological distress (i.e., elevated symptoms of depression or a mental health diagnosis) due to social isolation who will be randomly assigned to G4H or to a wait list control. The primary outcome against which the intervention will be assessed is loneliness and secondary outcomes include depression, social anxiety, and multiple group membership. We hypothesize a greater reduction in loneliness, depression, and anxiety and increase in multiple group membership for those receiving G4H compared to the wait list control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78846 0
Prof Catherine Haslam
Address 78846 0
School of Psychology
University of Queensland
St Lucia, Qld, 4072
Country 78846 0
Australia
Phone 78846 0
+ 61 (7) 3466 7565
Fax 78846 0
+ 61 (7) 3365 4466
Email 78846 0
[email protected]
Contact person for public queries
Name 78847 0
Prof Catherine Haslam
Address 78847 0
School of Psychology
University of Queensland
St Lucia, Qld, 4072
Country 78847 0
Australia
Phone 78847 0
+ 61 (7) 3466 7565
Fax 78847 0
+ 61 (7) 3365 4466
Email 78847 0
[email protected]
Contact person for scientific queries
Name 78848 0
Prof Catherine Haslam
Address 78848 0
School of Psychology
University of Queensland
St Lucia, Qld, 4072
Country 78848 0
Australia
Phone 78848 0
+ 61 (7) 3466 7565
Fax 78848 0
+ 61 (7) 3365 4466
Email 78848 0
[email protected]

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No Supporting Document Provided



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