Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000317493
Ethics application status
Approved
Date submitted
3/04/2025
Date registered
16/04/2025
Date last updated
18/06/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating Couple HOPES (i.e. Helping Overcome Posttraumatic Stress Disorder and Enhancing Satisfaction) within Australian first responders with Posttraumatic Stress Disorder and their partners.
Scientific title
Evaluating the effectiveness and feasibility of Couple HOPES (i.e. Helping Overcome Posttraumatic Stress Disorder and Enhancing Satisfaction) within Australian first responders with Posttraumatic Stress Disorder (PTSD) and their partners.
Secondary ID [1] 312755 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caregiver Burnout 336837 0
Posttraumatic Stress Disorder (PTSD) 334794 0
Caregiver Burden 334796 0
Condition category
Condition code
Mental Health 331356 331356 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Couples will be randomly allocated, using stratified counterbalancing based on occupation (i.e., police officer, firefighter, paramedic), to either receive immediate access to Couple HOPES or delayed access to Couple HOPES.

Couples allocated to receive 'immediate access to Couple HOPES' will immediately access the intervention. They will complete measures at three time-points, including baseline, mid-intervention and post-intervention. Participants in the 'immediate access' group will also complete a 3-month follow-up period, outside the scope of this clinical trial.

The intervention:
Couple HOPES (i.e., Helping Overcome PTSD and Enhance Satisfaction) is an online self-help intervention adapted from Cognitive Behavioural Conjoint Therapy (Monson, et al., 2021). It was designed for couples seeking to address PTSD symptoms and enhance relationship satisfaction. The program consists of 7 x 30-minute online modules, which are completed approximately once a week over 8 weeks. Couples watch educational content via video and apply these skills through in-session exercises and brief practice assignments completed between modules. They are completed online and from a location of the couples' choosing.

Module content encompasses psychoeducation regarding trauma recovery in the context of a relationship, increasing safety between partners, developing effective communication skills, engaging in behavioural experiments aimed at reducing avoidance, understanding the connection between thoughts, feelings and behaviours, and creating a plan to take these skills forward. Practice assignments build on what is learnt within the module and include activities like reflecting on how PTSD has impacted your life and relationship, catching your partner doing something nice, practicing communication skills like timeouts during arguments, paraphrasing skills and channel checking and sharing thoughts and feelings with their partner, and approaching previously avoided activities.

Participants are also supported by a coach, who helps them to overcome barriers encountered in completing the intervention and monitor symptoms. Participants will have access to 5 x coaching sessions up to 30 minutes in length conducted over Telehealth (i.e., via Zoom). Coaching sessions will be held after modules 1, 3, 5 and 7, with one additional meeting that couples can book at a time they need. Sessions will be guided using a coaching manual designed for the intervention (unpublished). Coaches will be completing postgraduate study in Psychology, receive training and supervision.

Adherence:
Adherence will be measured by completion of module content and attendance at coaching sessions. Coaches will help couples get the most out of the intervention by monitoring progress and helping them overcome any barriers to their participation.
Intervention code [1] 329287 0
Rehabilitation
Intervention code [2] 330769 0
Treatment: Other
Comparator / control treatment
No treatment control:
Couples allocated to receive 'delayed access to Couple HOPES' will wait 2 months before gaining access to Couple HOPES. During the two-month delay, participants are encouraged to continue their standard care processes as usual. They will complete measures at three time-points, including baseline, mid-delay and post-delay. This period of delay will be used as a waitlist control against which the intervention arm will be compared.

Participants in the 'delayed access' group will also complete a 1-month follow-up period after completing the intervention, outside the scope of this clinical trial.
Control group
Active

Outcomes
Primary outcome [1] 339113 0
Posttraumatic Stress Disorder.
Timepoint [1] 339113 0
Intervention group (first responder only): Baseline, 4 weeks and 8 weeks post-commencement of intervention (primary timepoint). . Control group (first responder only): Baseline, 4 weeks and 8 weeks post-enrolment (primary timepoint).
Primary outcome [2] 339115 0
Caregiver Burden as measured by the Zarit Burden Interview (ZBI-22)
Timepoint [2] 339115 0
Intervention group (partner only): Baseline, 4 weeks and 8 weeks post-commencement of intervention (primary timepoint). . Control group (partner only): Baseline, 4 weeks and 8 weeks post-enrolment (primary timepoint).
Primary outcome [3] 339114 0
Relationship Satisfaction as measured by the Couples Satisfaction Index (CSI-4).
Timepoint [3] 339114 0
Intervention group: Baseline, 4 weeks and 8 weeks post-commencement of intervention (primary timepoint). Control group: Baseline, 4 weeks and 8 weeks post-enrolment (primary timepoint).
Secondary outcome [1] 438993 0
Depression
Timepoint [1] 438993 0
Intervention group: Baseline, 4 weeks and 8 weeks post-commencement of intervention. Control group: Baseline, 4 weeks and 8 weeks post-enrolment
Secondary outcome [2] 438995 0
Alcohol Misuse
Timepoint [2] 438995 0
Intervention group: Baseline, 4 weeks and 8 weeks post-commencement of intervention. Control group: Baseline, 4 weeks and 8 weeks post-enrolment
Secondary outcome [3] 445378 0
Caregiver Burnout
Timepoint [3] 445378 0
Intervention group (partner only): Baseline, 4 weeks and 8 weeks post-commencement of intervention. Control group (partner only): Baseline, 4 weeks and 8 weeks post-enrolment
Secondary outcome [4] 438996 0
Partner Accomodation
Timepoint [4] 438996 0
Intervention group (partner only): Baseline, 4 weeks and 8 weeks post-commencement of intervention. Control group (partner only): Baseline, 4 weeks and 8 weeks post-enrolment
Secondary outcome [5] 438994 0
Anxiety
Timepoint [5] 438994 0
Intervention group: Baseline, 4 weeks and 8 weeks post-commencement of intervention. Control group: Baseline, 4 weeks and 8 weeks post-enrolment
Secondary outcome [6] 439039 0
Acceptability: Satisfaction with the Intervention (Intervention group only)
Timepoint [6] 439039 0
Intervention group: Within one week of completion of final module.
Secondary outcome [7] 438997 0
Anger
Timepoint [7] 438997 0
Intervention group: Baseline, 4 weeks and 8 weeks post-commencement of intervention. Control group: Baseline, 4 weeks and 8 weeks post-enrolment
Secondary outcome [8] 439042 0
Adherence to the Intervention (Intervention group only)
Timepoint [8] 439042 0
Intervention group: 8 weeks post-commencement of intervention
Secondary outcome [9] 438998 0
Conflict Resolution
Timepoint [9] 438998 0
Intervention group: Baseline, 4 weeks and 8 weeks post-commencement of intervention. Control group: Baseline, 4 weeks and 8 weeks post-enrolment
Secondary outcome [10] 438612 0
Sleep problems
Timepoint [10] 438612 0
Intervention group: Baseline, 4 weeks and 8 weeks post-commencement of intervention. Control group: Baseline, 4 weeks and 8 weeks post-enrolment
Secondary outcome [11] 438999 0
Close others collateral report of PTSD Symptoms
Timepoint [11] 438999 0
Intervention group (partner only): Baseline, 4 weeks and 8 weeks post-commencement of intervention. Control group (partner only): Baseline, 4 weeks and 8 weeks post-enrolment

Eligibility
Key inclusion criteria
Paramedic, Firefighter or Police Officer with clinically significant symptoms of post-traumatic stress disorder (PTSD), and their intimate partner.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No access to high-speed internet
- Unable to complete the modules together as a couple
- Unwilling to have coaching sessions video-recorded
- Couples where both partners have PTSD and the severity and impact of symptoms are such that it is not clearly distinguishable which partner is the first responder with PTSD and which is the support partner.
- Where there is current or a history of intimate partner violence within the relationship
- If one or both partners are experiencing elevated risk of suicide

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)
A spreadsheet will be prepared which randomly assigns couples to receive either immediate or delayed access to Couple HOPES. These cells will be made opaque so that the researcher determining eligibility will remain unaware of which group a potential couple may be allocated. Once a couple has been screened for eligibility and accepted into the study, the relevant opaque cell will be revealed and the couple will be allocated accordingly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified counterbalancing based on the occupation of the first responder (i.e. paramedic, police officer or firefighter), using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
30/05/2025
Date of last participant enrolment
Anticipated
1/07/2026
Actual
Date of last data collection
Anticipated
27/11/2026
Actual
Sample size
Target
42
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317186 0
University
Name [1] 317186 0
Monash University
Country [1] 317186 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 319455 0
None
Name [1] 319455 0
Address [1] 319455 0
Country [1] 319455 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315931 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315931 0
Ethics committee country [1] 315931 0
Australia
Date submitted for ethics approval [1] 315931 0
14/11/2023
Approval date [1] 315931 0
10/04/2024
Ethics approval number [1] 315931 0

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

Contacts
Principal investigator
Name 136254 0
Dr Alexander Wolkow
Address 136254 0
Monash University, Ground Floor, Building 1/270 Ferntree Gully Road, Notting Hill, VIC 3168 Australia
Country 136254 0
Australia
Phone 136254 0
+61 3 9905 9425
Fax 136254 0
Email 136254 0
[email protected]
Contact person for public queries
Name 136255 0
Sarah Cousins
Address 136255 0
Monash University, Ground Floor, Building 1/270 Ferntree Gully Road, Notting Hill, VIC 3168 Australia
Country 136255 0
Australia
Phone 136255 0
+61 3 9905 9425
Fax 136255 0
Email 136255 0
[email protected]
Contact person for scientific queries
Name 136256 0
Sarah Cousins
Address 136256 0
Monash University, Ground Floor, Building 1/270 Ferntree Gully Road, Notting Hill, VIC 3168 Australia
Country 136256 0
Australia
Phone 136256 0
+61 3 9905 9425
Fax 136256 0
Email 136256 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.