Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001257156
Ethics application status
Approved
Date submitted
26/08/2019
Date registered
11/09/2019
Date last updated
24/03/2024
Date data sharing statement initially provided
11/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of peer Vs clinician delivered culturally informed, skills based and manualised Group Emotional And Relationship Skills (GEARS) training for military, veteran, police and first responders who are at risk of, or have, chronic stress and trauma-related mental health injuries.
Scientific title
Evaluation of a trained peer vs clinician delivered pilot culturally informed, transdiagnostic, manualised, skills-based Group Emotional And Relationship Skills (GEARS) intervention targeting psychological health, emotional regulation and resilient functioning for military, veteran and first responders who are at risk of, or have, chronic stress and trauma-related mental health injuries
Secondary ID [1] 299119 0
none
Universal Trial Number (UTN)
U1111-1239-0801
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-traumatic stress disorder 314176 0
depression 314178 0
anxiety 314179 0
suicide 314180 0
substance abuse 314181 0
Condition category
Condition code
Public Health 312539 312539 0 0
Health promotion/education
Mental Health 312648 312648 0 0
Depression
Mental Health 312649 312649 0 0
Anxiety
Mental Health 312650 312650 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Evaluation of peer-delivered versus clinician-delivered Group Emotional and Relationship Skills (GEARS) program for military, veteran, police and first responder personnel. GEARS is a skills based training program targeting emotional regulation and interpersonal relationships, and consists of 12x120min facilitated sessions, delivered weekly. The first six sessions are about emotional regulation, and the second six sessions cover interpersonal relationships. The program is fully manualised and all facilitators have had training in delivery.
Non-Drug trial:
Materials – The GEARS program is a skills-based intervention and has a manualised workbook for both participants and facilitators, containing explanatory script, exercises and homework. Each session has components of psychoeducation about chronic stress and trauma, and the maladaptive coping mechanisms or behaviours that follow; a focus on Self and Identity from a uniformed service context; appropriate activities to demonstrate what these effects are, how they arise, and how they impact participants; and finish with an appropriate psychological tool (cognitive behavioural therapy, acceptance and commitment therapy, dialectical behavioural therapy, mindfulness activity) to address the issues raised during that session. The program outline is as follows:
1. GEARS introduction, with focus on effects of chronic stress and trauma on self, others, and relationships. Concepts of self and self-identity within a Service culture.
2. Emotions – purpose, meaning, and an introduction to breathing and mindful acceptance of emotional distress.
3. Emotional regulation – Cognitive interventions: restructuring and challenging less-helpful thinking patterns.
4. Emotional regulation – focus on behaviours and behavioural interventions.
5. Emotional regulation – focus on routine and structural interventions with behavioural activation task for stress vulnerability.
6. Emotional regulation – summary of service culture on values and identity; life stage approach to help manage transition from Service.
7. Introduction to relationships, healthy characteristics of relationships and relationship patterns.
8. Relationships – Roles, patterns, and maintaining healthy boundaries
9. Relationships – Developing and maintaining individuality within relationships, including effects of power and dependence.
10. Relationships – Managing conflict using effective communication. NB- session includes partners.
11. Relationships – Developing and maintaining intimacy for healthy relationships. NB – session includes partners.
12. Summary – review of progress during the program; effects on self and others; future plans for continued functioning.
Procedures – participants can be referred in by their clinicians (psychologists, psychiatrists, general practitioners); rehabilitation coordinators; other personnel from within their sponsoring organisations. An explanation of the program and clinician referral form can be found here: https://mesha.org.au/resources-and-support/our-programs/gears-program/
Note the referral form has the participation inclusion requirements of military or emergency service history, some concern about mental health, and the exclusion criteria of no active suicide plan or psychotic symptoms. Potential participants will be allocated to the wait-list for program sessions prior to being enrolled in a particular group. Allocation to GEARS program groups will be limited to the facilitator resources in the location because there are limited peer-facilitators available for delivery of the GEARS programs.
Who – Facilitators will be clinicians with a minimum of 3 years post-graduate employment experience, and have undergone formal training in the GEARS program. Peer facilitators will have participated in a GEARS group; observed another group; and have completed a Diploma of Counselling or equivalent prior to being able to deliver a program. All peer facilitators will be supervised during their delivery of the program by Dr Lane.
Mode of delivery – GEARS will only be done in a group format, and a combination of face-to-face and videoconferencing methods will be used for delivery of the sessions.
Number of Times – the GEARS consists of 12x120 minute sessions, delivered consecutively on a weekly basis. There will be an additional follow up for completion of the longitudinal evaluation at three and nine months post completion of the program.
Location of Intervention – the GEARS will be run at community outpatient facilities in Adelaide, Hobart, and other sites depending on popularity and need. Remote delivery via videoconferencing will also be used for participants in regional areas.
Allocation of participants to groups is non-randomised as it is dependent on their physical location and availability of programs at the time of enrollment.
Adherence / Fidelity – will be monitored through attendance records kept by group administrators from MESHA, or any other applicable organisation.
Intervention code [1] 315390 0
Rehabilitation
Intervention code [2] 315391 0
Behaviour
Intervention code [3] 315393 0
Treatment: Other
Comparator / control treatment
The initial design of the program had included a waitlist control group. Unfortunately, given the brief period of time that participants spent on the waitlist for a program (generally 2-4 weeks), the investigators felt that there was no material or academic benefit for this wait list group. The requirement for these participants to complete the questionnaire also added to the burden of participation. It was therefore removed from the project design. As there is no other viable comparator group, the study design now will only have the between time points pre, post, follow up 1 and 2 time points.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321189 0
Psychological health, as measured by statistically significant changes over time in screening tool scores for Anxiety – Generalised Anxiety Disorder 7 item scale (GAD7); Depression – Patient Health Questionnaire-9 item Depression module (PHQ-9); Anger – Dimensions of Anger (DAR); Post-Traumatic Stress Disorder – PTSD Check List-5 (PCL5); Psychological Distress - Kessler 10 (K-10); and Resilience- Ohio State University Brief Resilience Scale (Smith, Dalem et al, 2008).
Timepoint [1] 321189 0
(1) immediately prior to GEARS program at the start of the first session; (2) immediately post-GEARS program, (3) then at 3 months immediately post-GEARS, and (4) then at 6 months after that (ie 12months after commencement of GEARS program)
Primary outcome [2] 321298 0
Emotional Regulation, as measured by statistically significant changes over time in Emotional Avoidance - Difficulties in Emotional Regulation Short Form (DERSF) questionnaire
Timepoint [2] 321298 0
(1) immediately prior to GEARS program at the start of the first session; (2) immediately post-GEARS program, (3) then at 3 months immediately post-GEARS, and (4) then at 6 months after that (ie 12months after commencement of GEARS program)
Primary outcome [3] 321299 0
Functioning, as measured by statistically significant changes over time in Sheehan Disability Scale; and Well-Being Inventory (WBI) V(Vogt, et al 2019), and then presenteeism vs absenteeism in the workplace, as measured by 4 questions in the questionnaire.
Timepoint [3] 321299 0
(1) immediately prior to GEARS program at the start of the first session; (2) immediately post-GEARS program, (3) then at 3 months immediately post-GEARS, and (4) then at 6 months after that (ie 12months after commencement of GEARS program).
Secondary outcome [1] 374252 0
Suicidal Ideation, as measured by changes in the composite questionnaire for Suicidal Ideation: Four items assessed suicidal ideation, plans and behaviour over the past 12-months. Three of these questions were adapted from the National Survey of Mental Health and Wellbeing (2008), and one question was devised by Dr. Alan Verhagen. The composite scale was used and validated in the Australian Defence Force Transition and Wellbeing Project study from 2013-2015.
Timepoint [1] 374252 0
(1) immediately prior to GEARS program at the start of the first session; (2) immediately post-GEARS program, (3) then at 3 months immediately post-GEARS, and (4) then at 6 months after that (ie 12months after commencement of GEARS program).
Secondary outcome [2] 374563 0
Health care access and usage; barriers to care; reasons for seeking care - measures taken from SA Metropolitan Fire Services survey, Centre for Traumatic Stress Studies 2017.
Timepoint [2] 374563 0
(1) immediately prior to GEARS program at the start of the first session; (2) immediately post-GEARS program, (3) then at 3 months immediately post-GEARS, and (4) then at 6 months after that (ie 12months after commencement of GEARS program).
Secondary outcome [3] 374564 0
Psycho-Social Factors, as measured by changes in time in Social support- Items taken from the Schuster Social Support Scale (Schuster, 1990);
Social interaction, Housing, Financial hardship –items taken from The Household Income and Labour Dynamics in Australia (HILDA) Survey (Watson & Wooden, 2001);
Timepoint [3] 374564 0
(1) immediately prior to GEARS program at the start of the first session; (2) immediately post-GEARS program, (3) then at 3 months immediately post-GEARS, and (4) then at 6 months after that (ie 12months after commencement of GEARS program).
Secondary outcome [4] 407305 0
Physical pain assessed by using the Brief Pain Inventory
Timepoint [4] 407305 0
(1) immediately prior to GEARS program at the start of the first session; (2) immediately post-GEARS program, (3) then at 3 months immediately post-GEARS, and (4) then at 6 months after that (ie 12months after commencement of GEARS program).
Secondary outcome [5] 407306 0
Pain Disability Index to indicate functional impact of participant pain symptoms.
Timepoint [5] 407306 0
(1) immediately prior to GEARS program at the start of the first session; (2) immediately post-GEARS program, (3) then at 3 months immediately post-GEARS, and (4) then at 6 months after that (ie 12months after commencement of GEARS program).

Eligibility
Key inclusion criteria
Inclusion criteria: have had service in the military, police or another first responder organisation, and have identified as having concerns about their own mental health (including any formal diagnosis of mental health disorders).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: active suicidal ideation with an identified plan, or a concurrent psychotic mental state.

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
participants will be allocated to a peer, peer-clinician, or non-peer clinician facilitator depending on the availability of groups run by these facilitators within their area of residence and / or the organisation delivering the program.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANOVA/MANOVA / PAIRED T-TESTS for pre- post- and follow up time points 1 and 2

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2019
Actual
10/09/2020
Date of last participant enrolment
Anticipated
1/08/2024
Actual
31/01/2023
Date of last data collection
Anticipated
31/12/2024
Actual
31/05/2023
Sample size
Target
181
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 303662 0
Charities/Societies/Foundations
Name [1] 303662 0
Military and Emergency Services Health, Australia (MESHA)
Country [1] 303662 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Hospital Research Foundation
Address
62 Woodville Rd, Woodville SA 5011
Country
Australia
Secondary sponsor category [1] 303752 0
None
Name [1] 303752 0
Address [1] 303752 0
Country [1] 303752 0
Other collaborator category [1] 282202 0
Government body
Name [1] 282202 0
South Australian Metropolitan Fire Services
Address [1] 282202 0
Adelaide Fire Station, Level 1 West, 99 Wakefield Street, Adelaide South Australia 5000
Country [1] 282202 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304182 0
Depts of Defence and Veterans' Affairs Human Research Ethics Committee
Ethics committee address [1] 304182 0
Ethics committee country [1] 304182 0
Australia
Date submitted for ethics approval [1] 304182 0
18/08/2020
Approval date [1] 304182 0
10/09/2020
Ethics approval number [1] 304182 0
DDVA 271-20

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

Contacts
Principal investigator
Name 96066 0
Dr Jonathan Lane
Address 96066 0
Military And Emergency Services Health Australia (MESHA)
c/- The Hospital Research Foundation,
62 Woodville Rd, Woodville SA 5011
Country 96066 0
Australia
Phone 96066 0
+61 8 8243 1101
Fax 96066 0
+61 8 8244 1200
Email 96066 0
[email protected]
Contact person for public queries
Name 96067 0
Jonathan Lane
Address 96067 0
Military And Emergency Services Health Australia (MESHA)
c/- The Hospital Research Foundation,
62 Woodville Rd, Woodville SA 5011
Country 96067 0
Australia
Phone 96067 0
+61 8 8243 1101
Fax 96067 0
+61 8 8244 1200
Email 96067 0
[email protected]
Contact person for scientific queries
Name 96068 0
Jonathan Lane
Address 96068 0
Military And Emergency Services Health Australia (MESHA)
c/- The Hospital Research Foundation,
62 Woodville Rd, Woodville SA 5011
Country 96068 0
Australia
Phone 96068 0
+61 8 8243 1101
Fax 96068 0
+61 8 8244 1200
Email 96068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
non-identifiable raw scores (excluding age) for the questionnaire containing the inventories used for the primary and secondary outcome measures. The data will consist of an excel spreadsheet.
When will data be available (start and end dates)?
At the completion of the clinical trial when the results are published. This is anticipated to be December 2024. The results will be available for 3 years - until Dec 2027
Available to whom?
Identified researchers affiliated with an academic or government organisation.
Available for what types of analyses?
ANOVA / MANOVA / Paired T tests
How or where can data be obtained?
By contacting the primary investigator by email at [email protected]


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.