Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12622000175774
Ethics application status
Approved
Date submitted
14/12/2021
Date registered
2/02/2022
Date last updated
9/03/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Imagery Rescripting as an adjunct treatment for depression
Scientific title
Assessing treatment outcomes for patients with depression attending a group cognitive behavioural therapy programme by additionally treating aversive memories with Imagery Rescripting
Secondary ID [1] 305372 0
Nil
Universal Trial Number (UTN)
Trial acronym
DEPIR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 323725 0
Condition category
Condition code
Mental Health 321254 321254 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive evidence based group CBT psychological intervention (Mood and Anxiety Management Programs, MAMP), consisting of one session per day of approximately 3 hours duration, from Monday to Friday (i.e. 5 sessions per week). In addition, participants will be randomly assigned to three treatment conditions. The CBT group work is undertaken in the mornings during this time and the additional individual treatment sessions would take place over the two weeks of the group program in the afternoon, with at least one day between these individual sessions. Participants will continue to receive MAMP sessions in addition to the intervention sessions for the duration of the study period. All group treatment sessions are delivered face-to-face at the Hollywood Hospital clinic. While we will aim to complete individual sessions face-to-face, this may not always be feasible in light of the current pandemic. Therefore, sessions will be carried out via telehealth in instances where face-to-face interaction is not feasible (e.g., state lockdowns, researchers needing to quarantine/isolate). Evidence suggests that both of our proposed interventions (ImRs and CBT-based interventions) can be effectively delivered via telehealth (Osenbach et al., 2013; Paulik et al., 2021). Our preferred telehealth software will be Zoom, which has been approved for use by the Australian Psychological Society. To monitor adherence to group and individuals sessions, attendance will be monitored using a client session checklist.

Arm 1. Three individual 90 minute sessions utilising imagery rescripting (ImRs). ImRs is an evidence based psychological intervention for posttraumatic stress disorder. In ImRs, the patient is asked to focus on an aversive memory from their child-self perspective, identifying their thoughts, feelings and needs. Next they are then guided to imagine a different ending, such as someone intervening by stopping the abuse and caring for the needs of the child. Multiple suggestions are made until the patient identifies that the new imagined experience meets the core need of the child self in the original memory. The initial ImRs session would entail giving information on the intervention, establishing a safe place via imagery and identifying memories that would be targeting in subsequent session. The second and third session would involve rescripting identified memories as per ImRs procedure.

Arm 2. Three individual 90 minute sessions utilising Cognitive Behavioural Therapy Assertiveness Training (CBT-AT). CBT is an evidence based practice that is widely used in the treatment of psychological disorders. CBT-AT supports an individual to identify and alter unhelpful thoughts, feelings and behaviours. Sessions would focus on assertive communication, looking at the individuals beliefs around assertiveness and supporting them to practice more assertive behaviour

Arm 3. Treatment as usual / Delayed treatment. Participation in the group program with no additional individual sessions. however will be offered individual sessions following their six week follow up assessment.

All treatment sessions will be delivered by the researchers who are in their second year of their clinical masters and who are trained in both interventions.

The first cohort (2-4 participants) to be administered the assessments and intervention are treated as a trial and as such their data will not be included in the data analysis.
Intervention code [1] 321782 0
Behaviour
Intervention code [2] 322637 0
Treatment: Other
Comparator / control treatment
Comparator treatment CBT-A.
Control treatment: Treatment as usual . After follow- up they will be offered either CBT-A or ImRs which ever they choose.

Control group
Active

Outcomes
Primary outcome [1] 329033 0
Depression, Anxiety and Stress Scale (DASS)
Timepoint [1] 329033 0
Post-treatment (immediately following final session of MAP programme); 6 weeks post-treatment (primary time-point); 12 weeks post-treatment
Secondary outcome [1] 401240 0
Structured Clinician Interview for DSM Disorders – Fifth Edition (SCID 5)
Research Version (RV) Module A
Timepoint [1] 401240 0
6 weeks post-treatment ( which is 6 weeks after the final session of MAP programme) ; 12 weeks post-treatment.
Secondary outcome [2] 401241 0
Vividness of Mental Imagery scale (Vividness).
Timepoint [2] 401241 0
Post-treatment ( final session of MAP programme); 6 weeks post-treatment; 12 weeks post-treatment.
Secondary outcome [3] 401242 0
Rathus Assertiveness Scale.
Timepoint [3] 401242 0
Post-treatment ( final session of MAP programme); 6 weeks post-treatment; 12 weeks post-treatment.
Secondary outcome [4] 401243 0
Subjective Units of Distress scale (SUDS)
Timepoint [4] 401243 0
Post-treatment ( final session of MAP programme); 6 weeks post-treatment; 12 weeks post-treatment.
Secondary outcome [5] 401244 0
Maladaptive personality traits assessed using Young’s Schema Questionnaire – Rasch version (YSQ-R)
Timepoint [5] 401244 0
6 weeks post-treatment (which is 6 weeks after the final session of MAP programme)
Secondary outcome [6] 401245 0
The Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
Timepoint [6] 401245 0
Post-treatment ( final session of MAP programme); 6 weeks post-treatment; 12 weeks post-treatment.
Secondary outcome [7] 401343 0
Ambulatory heart rate variability (HRV), assessed using handheld electrocardiography machine.
Timepoint [7] 401343 0
Post-treatment ( final session of MAP programme); 6 weeks post-treatment; 12 weeks post-treatment.

Eligibility
Key inclusion criteria
Participation in the Hollywood Clinic Mood and Anxiety Management Program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

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)
Central randomisation using computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a planned sample size limited by the time schedule and group program that the participants are being recruited from. It is estimated that a sample size of approximately 45 can be obtained.

A Repeated Measures Analysis of Variance (ANOVA) will be used to investigate effects of treatment (ImRs; CBT-AT and treatment as usual (TAU)) over time (pre-treatment, post-treatment and follow-up).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/03/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20568 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 35351 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 309743 0
University
Name [1] 309743 0
Murdoch University
Country [1] 309743 0
Australia
Funding source category [2] 310319 0
Charities/Societies/Foundations
Name [2] 310319 0
Hollywood Private Hospital Research Foundation
Country [2] 310319 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St
Murdoch, WA, 6150
Country
Australia
Secondary sponsor category [1] 310799 0
Hospital
Name [1] 310799 0
Hollywood Private Hospital
Address [1] 310799 0
115 Monash Ave,
Nedlands WA 6009
Country [1] 310799 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309499 0
Murdoch University Human Research Ethics Committee (HREC)
Ethics committee address [1] 309499 0
Ethics committee country [1] 309499 0
Australia
Date submitted for ethics approval [1] 309499 0
17/09/2021
Approval date [1] 309499 0
08/11/2021
Ethics approval number [1] 309499 0
2021/211

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

Contacts
Principal investigator
Name 114366 0
A/Prof Christopher Lee
Address 114366 0
Discipline of Psychiatry, Medical School
University of Western Australia
35 Stirling Highway Crawley WA 6009
Country 114366 0
Australia
Phone 114366 0
+61403050431
Fax 114366 0
Email 114366 0
[email protected]
Contact person for public queries
Name 114367 0
Danielle Mathersul
Address 114367 0
Murdoch University
90 South Street,
Murdoch, WA, 6150
Country 114367 0
Australia
Phone 114367 0
+61893606542
Fax 114367 0
Email 114367 0
[email protected]
Contact person for scientific queries
Name 114368 0
Christopher Lee
Address 114368 0
Discipline of Psychiatry, Medical School
University of Western Australia
35 Stirling Highway Crawley WA 6009
Country 114368 0
Australia
Phone 114368 0
+61403050431
Fax 114368 0
Email 114368 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.