Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001086651
Ethics application status
Approved
Date submitted
20/09/2023
Date registered
16/10/2023
Date last updated
16/10/2023
Date data sharing statement initially provided
16/10/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A case series of imagery rescripting to treat generalised anxiety disorder
Scientific title
A multiple baseline case series evaluating the effects of imagery rescripting on symptoms of generalised anxiety disorder
Secondary ID [1] 310575 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised Anxiety Disorder 331527 0
Condition category
Condition code
Mental Health 328267 328267 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a 60-90 minute assessment session followed by an approximately 2-to-3 week baseline monitoring period.

Participants will then attend 10x 60-minute intervention sessions approximately weekly, occurring either online (via Zoom) or in person, dependant on participant preference. In these sessions, participants will engage in Imagery Rescripting intervention with a psychologist (Clinical Psychology Registrar).

Imagery rescripting procedures will be based on Arntz's Three Stage Protocol for rescripting early traumatic memories with adaptations to address worry. Sessions will involve identifying a current major worry, identifying an associated mental image, identifying an affectively-linked memory, engaging in rescripting of this memory (therapist-led and later participant-led), followed by reappraising the original worry and debriefing. Each session will include 1-2 imagery rescripting exercises.

Adherence to the intervention will be monitored by a board-approved supervisor in clinical psychology who is accredited as a schema therapy supervisor viewing a random selection of recordings of the intervention sessions, and assessing and providing feedback regarding adherence to the study protocol and the competence of the psychologist's delivery based on relevant subsection of the Schema Therapy Competency Rating Scale (STCS-I-1).

Participants will be asked to complete a range of questionnaire measures throughout the study and at 3-month follow up.
Intervention code [1] 327048 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336125 0
Generalised anxiety disorder symptom severity (Generalised Anxiety Disorder-7 item)
Timepoint [1] 336125 0
Pre-Baseline monitoring period, Post-Baseline monitoring period (2-weeks after baseline commenced), Mid-treatment (after 5th intervention session), Post-treatment (after 10th intervention session, primary endpoint), Follow-up (3 months after final intervention session)
Primary outcome [2] 336126 0
Worry Score (Penn State Worry Questionnaire)
Timepoint [2] 336126 0
Pre-Baseline monitoring period, Post-Baseline monitoring period (2-weeks after baseline commenced), Mid-treatment (after 5th intervention session), Post-treatment (after 10th intervention session, primary endpoint), Follow-up (3 months after final intervention session)
Primary outcome [3] 336127 0
Intrusive imagery (Intrusive Memory Interview)
Timepoint [3] 336127 0
Pre-Baseline monitoring period, Post-treatment (after 10th intervention session, primary endpoint)
Secondary outcome [1] 426925 0
Client satisfaction (Client Experiences Questionnaire)
Timepoint [1] 426925 0
Post-treatment (after 10th intervention session, primary endpoint)
Secondary outcome [2] 426926 0
Depression score (Patient Health Questionnaire-9 item)
Timepoint [2] 426926 0
Pre-Baseline monitoring period, Post-Baseline monitoring period (2-weeks after baseline commenced), Mid-treatment (after 5th intervention session), Post-treatment (after 10th intervention session, primary endpoint), Follow-up (3 months after final intervention session)

Eligibility
Key inclusion criteria
Inclusion criteria for participants taking part in this study include:
1. Aged 18 years or older
2. Received a primary diagnosis of Generalised Anxiety Disorder
3. Willing and able to attend an assessment interview and 10 intervention sessions approximately weekly (1-hour each) with a psychologist, and to complete regular questionnaires (ranging between 2 and 30 minutes)
4. Understand spoken English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for those who are not eligible to participate in the study include:
1. Under the age of 18
2. Unable to experience mental images
3. Experience active and not adequately managed suicidal intent or planning, symptoms of psychosis, bipolar disorder, substance use, or a tendency to dissociation

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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/10/2023
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
12
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314784 0
University
Name [1] 314784 0
The University of New South Wales (UNSW)
Country [1] 314784 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
NSW Kensington 2052
Country
Australia
Secondary sponsor category [1] 316853 0
None
Name [1] 316853 0
Address [1] 316853 0
Country [1] 316853 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313796 0
The University of New South Wales Human Research Ethics Committee A
Ethics committee address [1] 313796 0
Ethics committee country [1] 313796 0
Australia
Date submitted for ethics approval [1] 313796 0
17/07/2023
Approval date [1] 313796 0
05/09/2023
Ethics approval number [1] 313796 0
HC230463

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

Contacts
Principal investigator
Name 129370 0
Prof Jessica R Grisham
Address 129370 0
School of Psychology, UNSW Sydney, NSW Kensington 2052
Country 129370 0
Australia
Phone 129370 0
+612 9065 9982
Fax 129370 0
Email 129370 0
[email protected]
Contact person for public queries
Name 129371 0
Lauren Stavropoulos
Address 129371 0
School of Psychology, UNSW Sydney, NSW Kensington 2052
Country 129371 0
Australia
Phone 129371 0
+612 9065 9982
Fax 129371 0
Email 129371 0
[email protected]
Contact person for scientific queries
Name 129372 0
Lauren Stavropoulos
Address 129372 0
School of Psychology, UNSW Sydney, NSW Kensington 2052
Country 129372 0
Australia
Phone 129372 0
+612 9065 9982
Fax 129372 0
Email 129372 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?
Aggregate participant data underlying published results, after de-identification
When will data be available (start and end dates)?
Immediately following publication, ending 5 years after publication
Available to whom?
Any scientific researchers who wish to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access provided by the principal investigator, who can be contacted via email at [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.