Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000223437
Ethics application status
Approved
Date submitted
21/01/2025
Date registered
28/03/2025
Date last updated
28/03/2025
Date data sharing statement initially provided
28/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
An Investigation of Imagery Rehearsal Therapy for Trauma-related Nightmares in People with Post-traumatic Stress Disorder
Scientific title
An Investigation of the Efficacy of Imagery Rehearsal Therapy for Reducing the Frequency and Intensity of Trauma-related Nightmares in People with Post-traumatic Stress Disorder
Secondary ID [1] 313770 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder (PTSD) 336383 0
Condition category
Condition code
Mental Health 332909 332909 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a free 6-week intervention of imagery rehearsal therapy delivered online by a registered psychologist. Sessions will be individual and 90-minutes in duration. Participants will receive written handout materials which summarise key elements of the intervention.

The imagery rehearsal intervention involves 6 weekly sessions which includes topics of psychoeducation of nightmares, discussing the target/distressing nightmare, rescripting the nightmare to be less distressing and rehearsing the adapted dream. There is also a module of relaxation strategies (progressive muscle relaxation).

The materials are adapted from the imagery rehearsal manual developed by Andrea Phelps - Phelps, A., & Forbes, D. (2004). Imagery Rehearsal in the Treatment of Nightmares in PTSD: Practitioner’ Treatment Manual. Melbourne: Phoenix Australia.

The psychologist completed an online course developed by Barry Krakow in Imagery Rehearsal Therapy. This training is approximately 5 hours, and was completed in 2024.

Participants will have weekly sessions where adherence to the imagery rehearsal exercises will be reviewed. They will also complete daily questionnaires via an app which will ask them about their experience of nightmares and whether they practiced strategies discussed the previous week.

During the 1-week stabilisation phase - which occurs prior to the first intervention session - participants complete a pre-questionnaires on day 1 which assesses their PTSD and nightmare experiences. They will also complete a short daily questionnaire via an app which assesses their PTSD and nightmare experience each day. This allows us to obtain a baseline.
Intervention code [1] 330354 0
Treatment: Other
Comparator / control treatment
There is no control group. This study will be a within-subjects design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340438 0
Frequency of trauma-related nightmares
Assessment method [1] 340438 0
Self-report (Trauma-Related Nightmare Survey [TRNS]) as well as daily items designed for study.
Timepoint [1] 340438 0
Baseline, after six-week intervention, and at 3-month follow-up. The number and characteristics of posttraumatic nightmares experienced during the previous nights' sleep will also be assessed on a daily basis throughout the 1-week stabilisation phase and six-week intervention.
Secondary outcome [1] 444055 0
Posttraumatic Stress Disorder (PTSD) symptoms
Assessment method [1] 444055 0
Self-report questionnaire - the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) and International Trauma Questionnaire (ITQ)
Timepoint [1] 444055 0
Baseline, after six-week intervention and at 3-month follow-up. An abbreviated measure of PTSD symptoms will also be administered on a daily basis during the stabilisation phase and throughout the six weeks of the intervention.
Secondary outcome [2] 444056 0
Nightmare vividness
Assessment method [2] 444056 0
Self-report (items designed for the purpose of the present study)
Timepoint [2] 444056 0
Baseline, end of 6-week intervention, 3-month follow-up and daily throughout the 1-week stabilisation phase and six-week intervention period.
Secondary outcome [3] 444057 0
The number of weeks of intervention until a clinically significant change in the frequency of trauma related nightmares has occurred.
Assessment method [3] 444057 0
Self-report derived from nightmare frequency ratings designed for the purpose of the present study.
Timepoint [3] 444057 0
Weekly assessment of nightmare frequency from the commencement of the intervention until the end of the intervention.
Secondary outcome [4] 444072 0
Insomnia severity
Assessment method [4] 444072 0
Self-report questionnaire (Insomnia Severity Index [ISI])
Timepoint [4] 444072 0
Assessed weekly throughout the stabilisation and intervention phases.
Secondary outcome [5] 444355 0
Self-reported nightmare distress
Assessment method [5] 444355 0
Self-report (visual analogue scale item designed for the purpose of the present study)
Timepoint [5] 444355 0
Baseline, end of 6-week intervention, 3-month follow-up and daily throughout the 1-week stabilisation phase and six-week intervention period.
Secondary outcome [6] 444356 0
Self-reported nightmare emotional intensity
Assessment method [6] 444356 0
Self-report (visual analogue scale item designed for the purpose of the present study)
Timepoint [6] 444356 0
Baseline, end of 6-week intervention, 3-month follow-up and daily throughout the 1-week stabilisation phase and six-week intervention period.

Eligibility
Key inclusion criteria
• Fluent English-Speaker.
• 18 years or older.
• Must meet criteria for a DSM-5 Diagnosis of Post-Traumatic Stress Disorder (PTSD).
• Must be experiencing post-traumatic nightmares at least once a week which are distressing and result in the person waking up.
• Must have access to the internet and be able to commit to attending 6 weekly online sessions providing daily reports (via mobile phone) of nightmares and symptoms throughout the study.
• Willingness to give written informed consent and willingness to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Those who do not meet the inclusion criteria.
• Those who are receiving any concurrent psychological therapy intervention.
• Those who are taking medication such as Prazosin to manage their nightmares.
• Participants can be taking medication to manage other disorders or symptoms (e.g., antidepressants) but need to be on a stable dose for preceding 1-month before the intervention.
• Those who have an elevated risk of suicide (have daily ideation, current plans or intent) or who have engaged in deliberate self-harm within the past six months or more than five times in total during their lifetime.
• Those who have current psychosis.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
27/06/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318232 0
University
Name [1] 318232 0
University of Technology Sydney
Country [1] 318232 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Country
Australia
Secondary sponsor category [1] 320617 0
None
Name [1] 320617 0
Country [1] 320617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316874 0
UTS Health and Medical Research Ethics Committee
Ethics committee address [1] 316874 0
Ethics committee country [1] 316874 0
Australia
Date submitted for ethics approval [1] 316874 0
19/08/2024
Approval date [1] 316874 0
01/10/2024
Ethics approval number [1] 316874 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 139278 0
A/Prof David Berle
Address 139278 0
School of Medicine and Psychology, Australian National University, Building 39 (Science Road), 39 Science Road, Acton ACT 2601
Country 139278 0
Australia
Phone 139278 0
+61 2 6125 6337
Email 139278 0
david.berle@anu.edu.au
Contact person for public queries
Name 139279 0
David Berle
Address 139279 0
School of Medicine and Psychology, Australian National University, Building 39 (Science Road), 39 Science Road, Acton ACT 2601
Country 139279 0
Australia
Phone 139279 0
+61 2 6125 6337
Email 139279 0
David.Berle@anu.edu.au
Contact person for scientific queries
Name 139280 0
David Berle
Address 139280 0
School of Medicine and Psychology, Australian National University, Building 39 (Science Road), 39 Science Road, Acton ACT 2601
Country 139280 0
Australia
Phone 139280 0
+61 2 6125 6337
Email 139280 0
David.Berle@anu.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The small number of participants in the study means that that there is a low, but possible likelihood that the identification of participants could be established from de-identified data. Our ethics approval does not currently extend to the sharing of de-identified data.



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.