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Trial registered on ANZCTR


Registration number
ACTRN12618000440224
Ethics application status
Approved
Date submitted
7/03/2018
Date registered
27/03/2018
Date last updated
27/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Groups 4 Health in young people with depression: The Connecting Adolescents to Reduce Relapse trial (CARR).
Scientific title
Effectiveness of Groups 4 Health in young people with depression: The Connecting Adolescents to Reduce Relapse trial (CARR).
Secondary ID [1] 294061 0
None
Universal Trial Number (UTN)
Trial acronym
G4H: CARR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 306760 0
Social Isolation 306813 0
Condition category
Condition code
Mental Health 305853 305853 0 0
Depression
Mental Health 306006 306006 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Groups 4 Health Program:
Groups 4 Health (G4H) is a theory-driven, evidence-based, manualized psycho-therapeutic intervention that targets social isolation. G4H is designed to give young people the knowledge and skills needed to build and maintain their social world. G4H was developed using the latest science in social and clinical psychology, which suggests that group-based relationships are especially important for well-being.

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. 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 sub-optimal 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 future, identifying 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 weekly supervision from a registered psychologist, and a 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] 300425 0
Treatment: Other
Intervention code [2] 300426 0
Behaviour
Comparator / control treatment
Group CBT:
The comparison treatment used in this trial is Cognitive Behaviour Therapy (CBT), which is the psychological intervention with the strongest evidence base to date. CBT involves participants engaging in an active, collaborative discussion about how their thoughts, feelings, and action are linked. Specific strategies to challenge unhelpful thinking and modify unhelpful behaviours are taught and practised. Previous trials and meta-analyses have found CBT to be effective in reducing a wide range of mental illness symptoms, including depression which will be the focus in this trial. A manualised, 5 session form of CBT will be used that has been found to be effective in previous published trials (Stice, Rohde, Seeley & Gau, 2008).

Citation: Stice, E., Rohde, P., Seeley, J. R., & Gau, J. M. (2008). Brief cognitive-behavioural depression prevention program for high-risk adolescents outperforms two alternative interventions: A randomized efficacy trial. Journal of Consulting and Clinical Psychology, 76(4), 595-606. doi: 10.1037/a0012645
Control group
Active

Outcomes
Primary outcome [1] 304919 0
Depression symptoms, measured using the mean depression subscale score from the Depression Anxiety and Stress Scale (DASS-21), with an improvement greater than 3 points considered clinically significant.
Timepoint [1] 304919 0
1) Baseline at time of screening
2) Immediately post-intervention
3) At follow-up 1 year after completing the intervention (primary end point)
Primary outcome [2] 304955 0
Social Isolation, measured using the mean score from the UCLA Loneliness Scale, with a change of 2 points considered clinically significant.
Timepoint [2] 304955 0
1) Baseline at time of screening
2) Immediately post-intervention
3) At follow-up 1 year after completing the intervention (primary end point)
Secondary outcome [1] 343720 0
Multiple group memberships, measured using the mean score on the Multiple Group Memberships Scale.
Timepoint [1] 343720 0
1) Baseline at time of screening
2) Immediately post-intervention
3) At follow-up 1 year after completing the intervention
Secondary outcome [2] 344049 0
Compatibility of multiple group memberships, measured using the Group Listing Task and the mean score on the Group Compatibility Scale.
Timepoint [2] 344049 0
1) Baseline at time of screening
2) Immediately post-intervention
3) At follow-up 1 year after completing the intervention
Secondary outcome [3] 344050 0
Cohesion within the therapy group, measured using the mean score on the Group Cohesion Scale.
Timepoint [3] 344050 0
1) Baseline at time of screening
2) Immediately post-intervention
3) At follow-up 1 year after completing the intervention
Secondary outcome [4] 344051 0
Formation of new group memberships, measured using the New Group Memberships Scale.
Timepoint [4] 344051 0
1) Baseline at time of screening
2) Immediately post-intervention
3) At follow-up 1 year after completing the intervention
Secondary outcome [5] 344052 0
Existing group memberships and their importance, measured using the Group Listing Task.
Timepoint [5] 344052 0
1) Baseline at time of screening
2) Immediately post-intervention
3) At follow-up 1 year after completing the intervention
Secondary outcome [6] 344062 0
General well-being, measured using the mean score on the Short Warwick Edinburgh Wellbeing Scale.
Timepoint [6] 344062 0
1) Baseline at time of screening
2) Immediately post-intervention
3) At follow-up 1 year after completing the intervention
Secondary outcome [7] 344065 0
Importance of the mental illness identity, measured using a Centrality of Mental Illness Identity scale.
Timepoint [7] 344065 0
1) Baseline at time of screening
2) Immediately post-intervention
3) At follow-up 1 year after completing the intervention
Secondary outcome [8] 344067 0
Identification with the therapy group, measured using the mean score on the Group Identification Scale.
Timepoint [8] 344067 0
1) Baseline at time of screening
2) Immediately post-intervention
3) At follow-up 1 year after completing the intervention
Secondary outcome [9] 344068 0
Identification with the mental health service (e.g., UQ Psychology Clinic), measured using the mean score on the Group Identification Scale.
Timepoint [9] 344068 0
1) Baseline at time of screening
2) Immediately post-intervention
3) At follow-up 1 year after completing the intervention

Eligibility
Key inclusion criteria
1. Aged between 15 and 25 years
2. Experiencing depression, as indexed by a score greater than or equal to 10 on the DASS-21 depression scale (that may be comorbid with other mental health problems e.g., anxiety, psychosis)
3. English speaking
Minimum age
15 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently in receipt of other psychotherapy or medication
2. Current psychotic episode or severe personality disorder that would interfere with ability to participate in group work.
3. Current high risk suicidal ideation or severe self-harming behaviour.
4. Current alcohol and other substance dependence / intoxication
5. Severe neurological condition or severe learning impairment that will hinder engagement with the content of the proposed interventions

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
Parallel
Other design features
This is a non-inferiority trial. We hypothesise that both interventions will be effective in reducing depression symptoms, but that G4H will be superior in reducing the social isolation that causes depression. This trial will therefore test the capacity for G4H to function not only as a treatment, but also as relapse prevention for young people at risk of depression recurrence.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power calculations for a non-inferiority trial were conducted, using effect sizes and retention rates from our published pilot. Specifically, to have 0.80 power to detect a clinically significant difference (3 points on the DASS-21 depression subscale, using expected standard deviations for an adolescent population) with an alpha level of 0.05, N = 29 people per condition would need to be retained for one year follow up. Assuming 50% eligibility and 60% survival rates, which are consistent with our pilot data, we anticipate that screening 400 people for eligibility will lead to retention of approximately N=60 people per condition at follow-up.

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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 21889 0
4072 - University Of Queensland
Recruitment postcode(s) [2] 21890 0
4068 - Taringa
Recruitment postcode(s) [3] 21891 0
4020 - Redcliffe

Funding & Sponsors
Funding source category [1] 298687 0
Charities/Societies/Foundations
Name [1] 298687 0
Australian Rotary Health
Address [1] 298687 0
2nd Floor, 43 Hunter Street,
Parramatta NSW 2150
Country [1] 298687 0
Australia
Primary sponsor type
Individual
Name
Dr Tegan Cruwys
Address
School of Psychology
University of Queensland
St Lucia, Qld, 4072
Country
Australia
Secondary sponsor category [1] 297857 0
Individual
Name [1] 297857 0
Professor Catherine Haslam
Address [1] 297857 0
School of Psychology
University of Queensland
St Lucia, Qld, 4072
Country [1] 297857 0
Australia
Secondary sponsor category [2] 298181 0
Individual
Name [2] 298181 0
Victoria Gore-Jones
Address [2] 298181 0
Metro South Addiction and Mental Health Services
228 Logan Road
Woolloongabba, Qld, 4102
Country [2] 298181 0
Australia
Secondary sponsor category [3] 298182 0
Individual
Name [3] 298182 0
Dr Frances Dark
Address [3] 298182 0
Metro South Addiction and Mental Health Services
228 Logan Road
Woolloongabba, Qld, 4102
Country [3] 298182 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299640 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 299640 0
PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 299640 0
Australia
Date submitted for ethics approval [1] 299640 0
18/01/2018
Approval date [1] 299640 0
22/02/2018
Ethics approval number [1] 299640 0
HREC/18/QPAH/54
Ethics committee name [2] 299760 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 299760 0
University of Queensland
St Lucia, QLD, 4072
Ethics committee country [2] 299760 0
Australia
Date submitted for ethics approval [2] 299760 0
27/02/2018
Approval date [2] 299760 0
02/03/2018
Ethics approval number [2] 299760 0
2018000420

Summary
Brief summary
Social isolation is a major cause of depression onset and relapse in young people. Yet this is not directly targeted in current treatments for depression. To address this disconnect, our project will conduct a randomised controlled trial to assess the efficacy of a novel intervention that targets social isolation in young people with depression (called Groups 4 Health). Our trial will compare the effectiveness of Groups 4 Health to another effective treatment, group Cognitive Behaviour Therapy (CBT), at program completion and one-year follow up. Participants will be 200 young people aged 15-25, recruited from public and private mental health services in the Southeast Queensland region. We expect that both interventions will be effective in reducing depression symptoms, but that Groups 4 Health will be superior in reducing the social isolation that causes depression. This trial will test the capacity for Groups 4 Health to function not only as a treatment, but also as relapse prevention for young people at risk of depression recurrence. Therefore, the benefits of Groups 4 Health are expected to be particularly apparent by the one-year follow-up. This program offers a new approach to treatment and relapse prevention of the leading cause of disability among young people in Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81134 0
Dr Tegan Cruwys
Address 81134 0
School of Psychology
University of Queensland
St Lucia, Qld, 4072
Country 81134 0
Australia
Phone 81134 0
+ 61 437 261 537
Fax 81134 0
Email 81134 0
t.cruwys@uq.edu.au
Contact person for public queries
Name 81135 0
Dr Tegan Cruwys
Address 81135 0
School of Psychology
University of Queensland
St Lucia, Qld, 4072
Country 81135 0
Australia
Phone 81135 0
+ 61 437 261 537
Fax 81135 0
Email 81135 0
t.cruwys@uq.edu.au
Contact person for scientific queries
Name 81136 0
Dr Tegan Cruwys
Address 81136 0
School of Psychology
University of Queensland
St Lucia, Qld, 4072
Country 81136 0
Australia
Phone 81136 0
+ 61 437 261 537
Fax 81136 0
Email 81136 0
t.cruwys@uq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results