Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001713189
Ethics application status
Approved
Date submitted
28/11/2019
Date registered
5/12/2019
Date last updated
5/12/2019
Date data sharing statement initially provided
5/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Imagery Rescripting of Intrusive Autobiographical Memories in Depression - A Case Series
Scientific title
Imagery Rescripting of Intrusive Autobiographical Memories in Depression - A Case Series
Secondary ID [1] 299950 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 315397 0
Condition category
Condition code
Mental Health 313692 313692 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend 12 90 minute sessions, conducted weekly, in which they will be guided by the psychologist to identify an autobiographical event linked to their intrusive memories. The participant will be asked to rate the belief and affect associated with the memory out of 100.

Participants will then be guided to imaginally relive the event in as much detail as possible, describing what is occurring and how they feel. During the reliving, participants will be asked what they need to change in the scene in order to feel better emotionally. The therapist and participant will then collaboratively rescript the memory accordingly. Participants will then be asked to re-rate their original belief and affect about the event.

In subsequent sessions further modifications to the memory will be conducted as required, and additional intrusive memories will be identified and rescripted.
Intervention code [1] 316215 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322122 0
Diagnosis of Major Depressive Disorder as measured by Structured Diagnostic Interview for DSM-5 Anxiety, Mood, and Obsessive-Compulsive and Related Disorders (DIAMOND).
Timepoint [1] 322122 0
Comparison of DIAMOND score at pre-assessment (2 weeks prior to treatment commencement) to post-assessment (at 12th therapy session).
Secondary outcome [1] 377426 0
Frequency of intrusive memories and rumination as measured by Rumination and Intrusive Memory Questionnaire (RIMQ).
Timepoint [1] 377426 0
Comparison of RIMQ score at pre-assessment (2 weeks prior to treatment commencement) to post-assessment (at 12th therapy session).
Secondary outcome [2] 377427 0
Schema mode activation as measured by EMA modes questionnaire.
Timepoint [2] 377427 0
Comparison of EMA modes score at pre-assessment (2 weeks prior to treatment commencement) to post-assessment (at 12th therapy session).

Eligibility
Key inclusion criteria
Inclusion criteria: adult (minimum 18 years old); fluency in English; ability to provide informed consent; meets Diagnostic and Statistics Manual (DSM-5) criteria for a diagnosis of Major Depressive Disorder and experiences frequent and distressing intrusive memories of at least one autobiographical event.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: current suicidal or homicidal ideation or significant risk of harm to self or others; current psychotic symptoms or a psychotic disorder (bipolar disorder, schizophrenia or related psychosis), substance use disorder, current engagement in psychological treatment, commencement or change in anti-depressant medication 8 weeks prior to commencement of trial.

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
The relationship between depression symptoms, intrusive memories, rumination, intrusive memories and schema modes will be examined via a cross sectional design, employing correlational and multiple regression analyses.

The effectiveness of the imagery rescripting intervention on the frequency and distress associated with intrusive memories and depression symptoms will be examined by a single case series design with time series analysis or simulation modelling analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/09/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
30/12/2020
Actual
Sample size
Target
20
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 28671 0
2007 - Broadway

Funding & Sponsors
Funding source category [1] 304415 0
University
Name [1] 304415 0
University of Technology Sydney
Country [1] 304415 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
100 Broadway Chippendale NSW 2008
Country
Australia
Secondary sponsor category [1] 304670 0
None
Name [1] 304670 0
N/A
Address [1] 304670 0
N/A
Country [1] 304670 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304848 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [1] 304848 0
100 Broadway Ultimo NSW 2007
Ethics committee country [1] 304848 0
Australia
Date submitted for ethics approval [1] 304848 0
30/11/2018
Approval date [1] 304848 0
12/04/2019
Ethics approval number [1] 304848 0
ETH18-3063

Summary
Brief summary
The present study is a case series where individuals with a diagnosis of major depressive disorder will be offered 12 sessions of imagery rescripting. The first aim will be investigated using cross-sectional data collected at the baseline phase: to examine the prevalence, content, characteristics and responses to intrusive memories reported by participants. The second aim is to determine whether participants endorse features of maladaptive schema modes - as outlined in Young's (2006) Schema Mode Model. The final aim is to evaluate whether a 12-session imagery rescripting intervention is efficacious at reducing symptoms of major depressive disorder, as well as intrusive memories and rumination.
Hypotheses:
1. Participants will report frequent and distressing intrusive memories about a range of negative autobiographical events. Intrusive memories will be associated with the severity and maintenance of depressive symptomology.
2. Intrusive memories that are experienced as predominantly sensory will be associated will greater distress than those experiences as predominantly verbal.
3. Rumination will be positively associated with intrusive memories.
4. Participants will report activation of maladaptive child, parent and coping schema modes. Schema mode activation will be associated with the severity and maintenance of depressive symptomology.
5. Following 12 sessions of imagery rescripting, participants will experience less frequent and distressing intrusive memories, as well as reduced rumination and depression symptomology.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98402 0
Dr David Berle
Address 98402 0
Discipline of Clinical Psychology
Graduate School of Health
University of Technology Sydney
100 Broadway Ultimo NSW 2007
Country 98402 0
Australia
Phone 98402 0
+61 2 9514 1448
Fax 98402 0
Email 98402 0
[email protected]
Contact person for public queries
Name 98403 0
Ms Adele Stavropoulos
Address 98403 0
Discipline of Clinical Psychology
Graduate School of Health
University of Technology Sydney
100 Broadway Ultimo NSW 2007
Country 98403 0
Australia
Phone 98403 0
+61 2 9514 1448
Fax 98403 0
Email 98403 0
[email protected]
Contact person for scientific queries
Name 98404 0
Ms Adele Stavropoulos
Address 98404 0
Discipline of Clinical Psychology
Graduate School of Health
University of Technology Sydney
100 Broadway Ultimo NSW 2007
Country 98404 0
Australia
Phone 98404 0
+61 2 9514 1448
Fax 98404 0
Email 98404 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?
De-identified data will be provided to other researchers upon reasonable request.
When will data be available (start and end dates)?
Data will be available up to 7 years after the end of the trial.
Available to whom?
Researchers reviewing any journal papers derived from the present study.
Available for what types of analyses?
To review the present study analyses or meta-analytic purposes.
How or where can data be obtained?
By emailing [email protected]


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.