Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001559707
Ethics application status
Approved
Date submitted
6/12/2022
Date registered
19/12/2022
Date last updated
14/01/2024
Date data sharing statement initially provided
19/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating Imagery Rescripting as a Treatment for Unipolar Depression
Scientific title
A randomized controlled trial of Imagery Rescripting for Unipolar Depression in Adults
Secondary ID [1] 308563 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
unipolar depression 328425 0
Condition category
Condition code
Mental Health 325447 325447 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment will be an imagery rescripting (ImR) intervention following the protocol established by Wheatley and colleagues (Brewin et al., 2009; Wheatley et al., 2009; Wheatley & Hackmann, 2011). ImR is a collection of imagery techniques that alter negative meanings associated with autobiographical memories of distressing experiences.

Those in the immediate treatment condition will receive three individual weekly (60-90 minute) sessions delivered via an internet videoconferencing platform (Zoom).

The first treatment session involves participants providing a detailed account of the chosen memory or image, including sensory experience, emotions, cognitions and meanings associated with events. Participants will be asked what they need to happen in the imagery to reduce the distress associated with events, then guided to visualise this modification or alternative outcome (e.g., introducing safety, control, compassion, nurturance). Subsequent sessions will involve replication of the rescript with modifications as necessary, and rescripting of additional intrusive memories/images that are identified.

Following the three-week waitlist period, participants in the waitlist control condition will be offered the same three-session ImR intervention.

Treatment will be delivered by fully registered psychologists and clinical psychologists under the supervision of an experienced clinical psychologist. All treating psychologists will be thoroughly trained in the administration of the treatment protocol by the project investigators. All sessions will be recorded and at least 10% of sessions will be randomly selected for treatment fidelity.
Intervention code [1] 325012 0
Treatment: Other
Comparator / control treatment
The waitlist control group will receive the same treatment (three-week ImR intervention) following a three-week wait period.
Control group
Active

Outcomes
Primary outcome [1] 333305 0
Patient Health Questionnaire 9-Item (PHQ-9) (Kroenke et al., 2001)
Timepoint [1] 333305 0
Baseline
Post-completion of treatment period
1-month post-completion of intervention follow-up
Secondary outcome [1] 416564 0
Diagnostic Interview for Anxiety Mood, OCD, and Related Neuropsychiatric Disorders - Mood Disorders Module (Tolin et al., 2018)
Timepoint [1] 416564 0
Baseline
Post-completion of treatment period
1-month post-completion of intervention follow-up'
Secondary outcome [2] 416565 0
The Depression Anxiety Stress Scales – Short Form (Lovibond & Lovibond, 1995)
Timepoint [2] 416565 0
Baseline
Post-completion of treatment period
1-month post-completion of intervention follow-up
Secondary outcome [3] 416566 0
Ruminative Response Scale (Nolen-Hoeksema & Morrow, 1991)
Timepoint [3] 416566 0
Baseline
Post-completion of treatment period
1-month post-completion of intervention follow-up'
Secondary outcome [4] 416567 0
Repetitive Thinking Questionnaire 10 (McEvoy et al., 2014)
Timepoint [4] 416567 0
Baseline
Post-completion of treatment period
1-month post-completion of intervention follow-up
Secondary outcome [5] 416568 0
Appraisals of Intrusive Memories Scale (Newby & Moulds, 2010)
Timepoint [5] 416568 0
Baseline
Post-completion of treatment period
1-month post-completion of intervention follow-up
Secondary outcome [6] 416569 0
Early Maladaptive Schemas (EMS) assessed using the Young Schema Questionnaire Revised (Yalcin et al., 2022).
Timepoint [6] 416569 0
Baseline
Post-completion of treatment period
1-month post-completion of intervention follow-up
Secondary outcome [7] 416570 0
Schema Modes assessed using the Schema Mode Inventory II (Bamelis et al., 2011).
Timepoint [7] 416570 0
Baseline
Post-completion of treatment period
1-month post-completion of intervention follow-up
Secondary outcome [8] 416571 0
Work and Social Adjustment Scale (Mundt et al., 2002)
Timepoint [8] 416571 0
Baseline
Before each treatment session
1-month post-completion of intervention follow-up
Secondary outcome [9] 416572 0
Visual Analogue Mood Rating
Timepoint [9] 416572 0
Baseline
Before each treatment session
After each treatment session
1-month post-completion of intervention follow-up
Secondary outcome [10] 416573 0
Memory, Imagery and Encapsulated Meaning Ratings (Norton et al., 2021)
Timepoint [10] 416573 0
Baseline
Before each treatment session
After each treatment session
1-month post-completion of intervention follow-up

Eligibility
Key inclusion criteria
1. Adult (minimum 18 years old)
2. English speaking
3. Able and willing to provide written informed consent
4. Meets Diagnostic and Statistical Manual (DSM-5-TR, 2022) criteria for a current principal diagnosis of Major Depressive Disorder and/or Persistent Depressive Disorder (as assessed via the Diagnostic Interview for Anxiety Mood, OCD, and Related Neuropsychiatric Disorders [DIAMOND]; Tolin et al., 2018).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Principal mental health diagnosis other than Major Depressive Disorder or Persistent Depressive Disorder (as assessed via the DIAMOND; Tolin et al., 2018).
2. Current engagement in other psychological treatment
3. Current active psychotic symptoms
4. Current active suicidal or homicidal ideation, or significant risk of harm to self or others.
5. Significant cognitive/intellectual impairment as assessed during diagnostic interview
6. Do not have access to a computer with a camera and stable internet on a regular basis

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization will be conducted using a random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will be randomly assigned to an immediate treatment group (n = 20) or a waitlist control group (n = 20). Group 1 will receive immediate access to three-session ImR intervention, and Group 2 will receive treatment after a three-week wait period.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
An a priori power analysis was conducted using G*Power version 3.1.9.6 (Faul et al., 2007) for sample size estimation. With a significance criterion of a = .05 and power = .80, the minimum sample size needed to detect a large effect size (consistent with large effect sizes reported by Ma & Lo, 2022) is N = 36 for ANOVA (repeated measures [3], between groups [2]). Thus, the proposed sample size of N = 40 is more than adequate to test the study hypothesis.

The impact of ImR vs waitlist control on primary and secondary outcomes will be conducted using repeated measures analysis of variance (ANOVA). Significant interaction effects will be followed up with within group t-tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312810 0
University
Name [1] 312810 0
University of Technology Sydney
Country [1] 312810 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Graduate School of Health. University of Technology Sydney. PO Box 123 Broadway, Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 314455 0
None
Name [1] 314455 0
Address [1] 314455 0
Country [1] 314455 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312095 0
University of Technology Sydney Health and Medical Research Ethics Committee (HMREC)
Ethics committee address [1] 312095 0
Ethics committee country [1] 312095 0
Australia
Date submitted for ethics approval [1] 312095 0
11/07/2022
Approval date [1] 312095 0
30/11/2022
Ethics approval number [1] 312095 0
UTS HREC REF NO. ETH22-7280

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

Contacts
Principal investigator
Name 123454 0
Dr Alice Norton
Address 123454 0
Clinical Psychology Unit, Mallett St Building F (M02F), The University of Sydney, Camperdown, NSW, 2006.
Country 123454 0
Australia
Phone 123454 0
+61 2 9351 0988
Fax 123454 0
Email 123454 0
[email protected]
Contact person for public queries
Name 123455 0
Alice Norton
Address 123455 0
Clinical Psychology Unit, Mallett St Building F (M02F), The University of Sydney, Camperdown, NSW, 2006.
Country 123455 0
Australia
Phone 123455 0
+61 2 9351 0988
Fax 123455 0
Email 123455 0
[email protected]
Contact person for scientific queries
Name 123456 0
Alice Norton
Address 123456 0
Clinical Psychology Unit, Mallett St Building F (M02F), The University of Sydney, Camperdown, NSW, 2006.
Country 123456 0
Australia
Phone 123456 0
+61 2 9351 0988
Fax 123456 0
Email 123456 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.