Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000172707
Ethics application status
Approved
Date submitted
17/12/2021
Date registered
2/02/2022
Date last updated
12/05/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility, Acceptability and initial Outcomes of a Psychological Adjustment and Reintegration Training Program for Ex-Service Personnel
Scientific title
Feasibility, Acceptability and initial Outcomes on Military-Civilian Adjustment and Reintegration Measure (M-CARM), Depression Anxiety Stress Scale 21-items (DASS-21), PTSD Checklist for DSM-5 (PCL-5), and The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) of a Psychological Adjustment and Reintegration Training Program for Transitioned Veterans
Secondary ID [1] 306074 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 324874 0
Condition category
Condition code
Mental Health 322171 322171 0 0
Depression
Mental Health 322172 322172 0 0
Other mental health disorders
Mental Health 322310 322310 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program will be delivered in 2-hourly sessions, once a week for eight weeks, with a potential for a booster session after 3 months (additional session 30-60 minutes in duration). Each of the eight- sessions will include a review of information provided, an educational component during which new materials are introduced, group discussion, and practical exercises.

The mode of delivery, is groups between 5-8 participants. Materials provided include a workbook which has been designed specifically for this program by two clinical psychologists and reviewed by the clinicians delivering the program.

The delivery of the potential booster session is decided by the participants, a survey is sent out at 3-months evaluating their desire for an in-person, on-line, or no booster session.

Examples of the 'practical exercises' delivered as part of the intervention include group discussions e.g., discussing identity and identity loss, communication strategies, identifying their communication styles, practicing open/closed questions, tips for managing sensitive questions, identifying life values, identifying character strengths, goal setting activities.

The program will be delivered by experienced mental health clinicians/practitioners. If eligible, clinicians will be registered with the Australian Health Practitioners Regulation Agency (AHPRA) and have experience facilitating group programs as well as training in assessing and managing discomfort/distress. Further, these facilitators will engage in supervision activities with a senior clinical psychologist (also registered with AHPRA).

This pilot will be undertaken at Gallipoli Medical Research Foundation and Ramsay Health facility – Greenslopes Private Hospital (GPH) in Brisbane, Australia. The program will be delivered within the Day Centre of the Keith Payne Unit, or the University of Queensland tutorial rooms on GPH campus. Both of these facilities within GPH have been used by Gallipoli Medical Research Foundation (GMRF) to deliver psychological group programs to the veteran community. All staff required for this project are employees of Gallipoli Medical Research Foundation and/or Greenslopes Private Hospital.

Topic: Social Connections
Module aim: to provide ex-service personnel with an understanding of why social connections are important, how to identify and address common barriers to social connection, and how to develop social relationships outside of the military.

Topic: Effective Communication in Civilian Life
Module aim: to provide psychoeducation about different communication styles – passive, aggressive, passive-aggressive, and assertive, identify your own communication style and barriers to effective communication. Developing empathy, effective listening and giving and receiving compliments.

Topic: Purpose
Module aim: to help individuals identify how they can develop a sense of purpose outside of military life.

Topic: Beliefs about Civilians
Module aim: to help understand how belief systems operate, and the impact of unhelpful beliefs and thoughts, how certain beliefs about civilians have developed and why they can contribute to problems when adjusting to civilian life.

Topic: Resentment & Regret
Module aim: to help understand the impact of unresolved resentment and regret to identify whether these issues are impacting on civilian life (including common causes of resentment and regret in ex-service personnel), and the detrimental impacts of resentment and regret.

Topic: Regimentation
Module aim: education about regimentation, how it was functional in the military, and the importance of flexibility in thinking and behaviour in civilian life.

Topic: Help-seeking & relapse prevention plan
Module aim: education about the benefits of help seeking in the civilian world, identifying common help seeking barriers, and how to find quality help.

To ensure treatment fidelity, facilitators will each complete a facilitator adherence checklist at the end of each session.
Intervention code [1] 322477 0
Treatment: Other
Intervention code [2] 322478 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329938 0
Change in overall Military-Civilian Adjustment and Reintegration Measure (M-CARM) post-discharge version score
Timepoint [1] 329938 0
Pre-intervention (week 1), post-intervention (week 8 - primary end point), follow-up (3 months following completion of program; week 20).
Primary outcome [2] 329939 0
Change in number of Military-Civilian Adjustment and Reintegration Measure (M-CARM) post-discharge version needs
Timepoint [2] 329939 0
Pre-intervention (week 1), post-intervention (week 8 - primary end point), follow-up (3 months following completion of program; week 20).
Secondary outcome [1] 404357 0
Change in depression, anxiety, stress scale (DASS-21) scores
Timepoint [1] 404357 0
Pre-intervention (week 1), post-intervention (week 8 - primary end point), follow-up (3 months following completion of program; week 20).
Secondary outcome [2] 404358 0
Change in Posttraumatic stress disorder (PTSD) Checklist for DSM-5 (PCL-5) scores
Timepoint [2] 404358 0
Pre-intervention (week 1), post-intervention (week 8 - primary end point), follow-up (3 months following completion of program; week 20).
Secondary outcome [3] 404359 0
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF).
Timepoint [3] 404359 0
Pre-intervention (week 1), post-intervention (week 8 - primary end point), follow-up (3 months following completion of program; week 20).
Secondary outcome [4] 404804 0
Feasibility of delivering the program to ex-service personnel within an existing outpatient hospital setting. Assessed using three components specifically:

1. Demand: Demand for the intervention can be assessed through documenting the uptake of the selected intervention in the target population. Assessed by
- Number of expressions of interest and referrals received (data for all referrals is kept as part of study records which will form part of the analysis).
- Recruitment rate (%) including proportion of eligible participants enrolling in the study and reasons for non-participation (data is kept of all referrals and kept as part of study records which will be analyzed).
- Suitability of eligibility criteria (i.e. restrictive/too inclusive) data is kept from discussions with recruiters and kept as part of study records which will be analyzed as part of study).

2. Implementation: The extent to which a new intervention can be delivered to intended participants in a defined and appropriately controlled manner. Assessed by:
- Facilitator adherence checklist (checklist has been developed will be kept as part of study records and will form part of analysis).
- Intervention adherence rate (% of sessions completed by participants) attendance is recorded for each session and will be analyzed as part of study data.
- Retention/attrition rates (%) attendance and attrition is recorded by the facilitators and entered by researchers onto the database and will be analyzed as part of study data.

3. Integration: The level of system change needed to integrate a new program or process into an existing infrastructure or program. Formal discussions (e.g. records such as meeting minutes, changes/re-iterations of programs) will be assessed via study audit of records.
- Efficiency of referral pathway and delivery of program using existing GPH resources/facilities. Formal discussions (e.g. records such as meeting minutes, changes/re-iterations of programs) will be assessed via study audit of records in addition to facilitator feedback forms will be assessed.
- Number of referrals generated by existing clinical staff. All referrals will be recorded and assessed.
Timepoint [4] 404804 0
Demand: Post-recruitment completion for all programs.
Implementation: During program delivery each week.
Integration: Post-recruitment completion for all programs.
Secondary outcome [5] 404805 0
Acceptability (the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate). This study will use:

1. Affective attitude: How an individual feels about the intervention, assessed using:
- Post program feedback questionnaire (study specific source).
- Facilitator feedback questionnaire (study specific source).

2. Burden or discomfort: The perceived amount of effort that is required to participate in the intervention, assessed using:
- Reasons for non-attendance (each participant contacted prior to/and on day of attendance by research team to confirm transport (if eligible DVA gold/white card holder). If participant cannot attend this is noted by the research team.
- Post-program feedback questionnaire (study specific source).

3. Perceived effectiveness: The extent to which the intervention is perceived as likely to achieve its purpose, assessed using:
- Post-program feedback questionnaire (study specific source).
Timepoint [5] 404805 0
Week 8 post commencement of intervention
Secondary outcome [6] 405236 0
Participant preferences and uptake of an online vs in-person ‘booster’ session" will be assessed in this study (study specific source)
Timepoint [6] 405236 0
Week 12 post completion of intervention.

Eligibility
Key inclusion criteria
Participants must meet all of the following inclusion criteria:
Male or Female ex-serving personnel.
Age 18-75 years.
Self-reported difficulties adjusting to civilian life post service assessed using the question: Have you experienced difficulties adjusting to civilian life? Yes/No
Current M-CARM scores demonstrating difficulties in the majority of the five M-CARM factors (i.e. Help seeking, Social connections and Purpose, Resentment and regret, Beliefs about civilians, Regimentation).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if one of the following criteria applies:
Currently hospitalised as an in-patient for a psychological condition.
Have presented to an emergency department with acute psychiatric symptoms within the previous four weeks.
Unable or unwilling to commit to the scheduled program sessions.

Wait-list option:
Participants may be wait-listed if they meet all eligibility criteria but are currently undertaking another group therapy intervention.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For a one-way ANOVA investigating within-subjects differences at three time-points (pre, post, and follow-up), with a power of 0.80, we would require approximately 42 participants to detect a small-moderate effect size. At 20% attrition (n = 34), with this sample size, we would still be adequately powered to detect a moderate effect size. In a pilot study such as this one, the primary objective is to trial procedural aspects of the intervention, establish feasibility, and provide insight into the approximate effect size of treatment to inform the design and sample size of a larger-scale study. A sample size of approximately 30-40 would enable a sound investigation of feasibility and acceptability of the program content, as well as a critical assessment of procedural aspects. It is also an appropriate study size to gain a trend of the treatment effect, where the sole objective is not to obtain an exact determination of the effect size given that the reintegration program may undergo adjustments to the content or delivery depending on findings and observations.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/08/2021
Date of last participant enrolment
Anticipated
15/10/2022
Actual
Date of last data collection
Anticipated
6/03/2023
Actual
Sample size
Target
42
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21355 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 36247 0
4120 - Greenslopes

Funding & Sponsors
Funding source category [1] 310408 0
Charities/Societies/Foundations
Name [1] 310408 0
Ramsay Hospital Research Foundation
Country [1] 310408 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Gallipoli Medical Research Foundation
Address
Gallipoli Medical Research Foundation
Greenslopes Private Hospital
121 Newedgate Street, Greenslopes Queensland, 4101
Country
Australia
Secondary sponsor category [1] 311564 0
None
Name [1] 311564 0
Address [1] 311564 0
Country [1] 311564 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310056 0
Department of Defence and Veterans’ Affairs Human Research Ethics Committee
Ethics committee address [1] 310056 0
Ethics committee country [1] 310056 0
Australia
Date submitted for ethics approval [1] 310056 0
Approval date [1] 310056 0
01/06/2021
Ethics approval number [1] 310056 0
332-21

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

Contacts
Principal investigator
Name 116334 0
Dr Madeline Romaniuk
Address 116334 0
Associate Director – Mental Health Research
Gallipoli Medical Research Foundation
Greenslopes Private Hospital
121 Newedgate Street, Greenslopes, Queensland, 4101
Country 116334 0
Australia
Phone 116334 0
+61 7 3394 7284
Fax 116334 0
Email 116334 0
[email protected]
Contact person for public queries
Name 116335 0
Kerri-Ann Woodbury
Address 116335 0
Principal Research Fellow – Transition and Reintegration
Gallipoli Medical Research Foundation
Greenslopes Private Hospital
121 Newedgate Street, Greenslopes, Queensland, 4101
Country 116335 0
Australia
Phone 116335 0
+61 7 3394 7284
Fax 116335 0
Email 116335 0
[email protected]
Contact person for scientific queries
Name 116336 0
Kerri-Ann Woodbury
Address 116336 0
Principal Research Fellow – Transition and Reintegration
Gallipoli Medical Research Foundation
Greenslopes Private Hospital
121 Newedgate Street, Greenslopes, Queensland, 4101
Country 116336 0
Australia
Phone 116336 0
+61 7 3394 7284
Fax 116336 0
Email 116336 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?
All individual participant data collected during the trial, after de-identification may be made available upon request and approval by DDVA HREC
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of DDVA HREC
Available for what types of analyses?
Any purpose approved by the principal investigator and DDVA HREC
How or where can data be obtained?
Data can be made available upon request to the principal investigator and approval by DDVA HREC [email protected] or [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3894Basic resultsNo 383319-(Uploaded-07-11-2023-11-58-24)-Basic results summary.pdf
4169Plain language summaryNo The study aimed to evaluate the feasibility, accep... [More Details]
4816Other filesNo Ramsay Hospital Research Foundation Webinar, Accep... [More Details]

Documents added automatically
No additional documents have been identified.