ANZCTR - Registration

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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]

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

depression

anxiety

suicide

substance abuse

Condition category

Condition code

Public Health

Health promotion/education

Mental Health

Depression

Mental Health

Anxiety

Mental Health

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]

Rehabilitation

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

(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]

Emotional Regulation, as measured by statistically significant changes over time in Emotional Avoidance - Difficulties in Emotional Regulation Short Form (DERSF) questionnaire

Timepoint [2]

Primary outcome [3]

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]

Secondary outcome [1]

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]

Secondary outcome [2]

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]

Secondary outcome [3]

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]

Secondary outcome [4]

Physical pain assessed by using the Brief Pain Inventory

Timepoint [4]

Secondary outcome [5]

Pain Disability Index to indicate functional impact of participant pain symptoms.

Timepoint [5]

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]

Charities/Societies/Foundations

Name [1]

Military and Emergency Services Health, Australia (MESHA)

Address [1]

60 Woodville Rd, Woodville SA 5011

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Government body

Name [1]

South Australian Metropolitan Fire Services

Address [1]

Adelaide Fire Station, Level 1 West, 99 Wakefield Street, Adelaide South Australia 5000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Depts of Defence and Veterans' Affairs Human Research Ethics Committee

Ethics committee address [1]

Departments of Defence and Veterans’ Affairs Human Research Ethics Committee, CP3-7-038 Campbell Park Offices, PO Box 7912, Canberra BC ACT 2610

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/08/2020

Approval date [1]

10/09/2020

Ethics approval number [1]

DDVA 271-20

Summary

Brief summary

The Group Emotional and Relationship Skills (GEARS) program is a culturally informed, fully manualized and skills-based group program consisting of 12 x 120-minute sessions. There are six sessions on emotional regulation, and six sessions on interpersonal relationships. Common themes of the program are how chronic stress and trauma impact the culturally specific Service concepts of self and identity, and adversely affect emotional regulation and relationships, therefore adversely impacting mental health and functioning. The purpose of the 12-week program is to improve psychological functioning in day-to-day life, to provide participants with mental health psychoeducation about chronic stress and trauma and its effects on mental health, and an improved level of emotional stability and functional skills in managing themselves and their relationships. In real terms, this means a capacity to either engage or continue in further treatment (if/as required), and to continue their lives with a range of skill sets that will improve their capacity to tolerate distress, build resilience, and maintain their interpersonal relationships. As per the International Society for Traumatic Stress Studies (ISTSS) guidelines, this is a phase 1, generalised intervention that provides both stabilisation and skills building. It is not a treatment program as it specifically avoids addressing individual trauma. Stabilization therapies are associated with moderate to large effect sizes for PTSD, emotion regulation and social/interpersonal outcomes, and are more effective when combined with skills development. GEARS meets all these criteria and will be delivered by accredited peer facilitators and peer- and non-peer mental health clinicians in order to evaluate whether a skills based and manualised program delivered by counsellors is as effective as when delivered by more highly qualified non-peer mental health clinicians, Peers are considered to be those who have lived experience in Military, Police or first responder organisations, and have been targeted in order to utilise the benefits of having facilitators who have lived experience and therefore the appropriate cultural knowledge to relate to participants, and serve as role models for healthy functioning. The study outcomes will be the primary factors of psychological health (as measured by a composite of screening tools for common mental health conditions); emotional regulation, (as measured by two emotional regulation scales); and functioning, (as measured by disability, quality of life, and resilience scales). Secondary outcomes are suicidal ideation, physical health, and psycho-social factors, which are again measured by a composite of different scales.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jonathan Lane

Address

Military And Emergency Services Health Australia (MESHA)
c/- The Hospital Research Foundation,
62 Woodville Rd, Woodville SA 5011

Country

Australia

Phone

+61 8 8243 1101

Fax

+61 8 8244 1200

jlane@mesha.org.au

Contact person for public queries

Name

Jonathan Lane

Address

Military And Emergency Services Health Australia (MESHA)
c/- The Hospital Research Foundation,
62 Woodville Rd, Woodville SA 5011

Country

Australia

Phone

+61 8 8243 1101

Fax

+61 8 8244 1200

jlane@mesha.org.au

Contact person for scientific queries

Name

Jonathan Lane

Address

Military And Emergency Services Health Australia (MESHA)
c/- The Hospital Research Foundation,
62 Woodville Rd, Woodville SA 5011

Country

Australia

Phone

+61 8 8243 1101

Fax

+61 8 8244 1200

jlane@mesha.org.au

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 jlane@mesha.org.au

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.

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