Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000435886
Ethics application status
Approved
Date submitted
16/02/2021
Date registered
16/04/2021
Date last updated
27/06/2022
Date data sharing statement initially provided
16/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can we help people with eating disorders get more out of therapy by targeting executive functioning inefficiencies while they are waiting to get into therapy?
Scientific title
The effect of waitlist cognitive remediation therapy on treatment retention and outcome
following 10-session cognitive behavioural therapy for non-underweight eating disorders
Secondary ID [1] 303477 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 320791 0
Condition category
Condition code
Mental Health 318611 318611 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive remediation therapy (CRT). Participants randomised to this condition receive one face-to-face CRT session prior to a one-month wait to receive 10-session cognitive behavioural therapy (CBT-T) for eating disorders. They are also assigned homework tasks to complete during the wait.

The CRT session will be administered by a provisional psychologist. The session is 50 minutes in length. The session involves an introduction to CRT and the following tasks: complex pictures, how to, switching ability, and embedded words. All tasks aim to improve central coherence and set shifting. Session attendance is used to monitor adherence to the intervention.

The CRT homework tasks, also targeting central coherence and set shifting, comprise the following tasks: prioritising, up and down, illusions, and behavioural changes. Homework is completed each week in a booklet, and adherence is monitored through a follow-up discussion in session. Participants are sent weekly email reminders to do so. There is one 15 minute homework task per week for four weeks.

The CBT-T covers learning about and normalising eating, challenging beliefs around eating, food and weight, body image work, and relapse prevention. Sessions are weekly, for 4-10 weeks with two follow-up appointments, and 50 minutes in length. Sessions are conducted in-person or via telehealth for rural clients. The CBT-T is delivered by provisional psychologists supervised by Professors Wade and Waller. Session attendance and homework completion is used to monitor adherence. Sessions are delivered over a 4-10 week session, as therapy is terminated after session 4, as per the CBT-T protocol, if early progress has not been made to avoid wasting clients' time as this is a consistent predictor of treatment outcome.
Intervention code [1] 319766 0
Treatment: Other
Comparator / control treatment
Active control: Psychoeducation. Participants in this condition are provided a Centre for Clinical Interventions handout “Eating Disorders & Neurobiology” half way through the one-month wait for CBT-T. This handout discusses eating disorders and emphasises the malleability of the brain,

Passive control: Participants in this condition do not receive contact and are not required to do anything during the one-month wait for CBT-T.
Control group
Active

Outcomes
Primary outcome [1] 326573 0
Eating disorder psychopathology (EDE-Q)
Timepoint [1] 326573 0
Baseline (assessment pre-waiting period), pre-CBT-T (1 week before 1st session), mid-CBT-T (post-session 4), post-CBT-T (post session 9), 1-month post-CBT-T, and 3-months post-CBT-T

Primary timepoints: pre-CBT-T and post-CBT-T.

Post-CBT-T is after session 9 as session 10 is relapse prevention.
Primary outcome [2] 326576 0
Remission: composite outcome: BMI > 18.5, Global EDE < 1.8, and absence of binge eating/purging behaviours).
Binge/Purge assessed through clinical discussion, ED15, and EDE-Q.
Timepoint [2] 326576 0
Baseline (assessment pre-waiting period), pre-CBT-T (1 week before 1st session), mid-CBT-T (post-session 4), post-CBT-T (post session 9), 1-month post-CBT-T, and 3-months post-CBT-T

Primary timepoints: pre-CBT-T and post-CBT-T.

Post-CBT-T is after session 9 as session 10 is relapse prevention.
Primary outcome [3] 326578 0
Drop out (consulting therapist and client spreadsheet - participant electing to withdraw or being referred on for intensive support before completing CBT-T)
Timepoint [3] 326578 0
Baseline (assessment pre-waiting period), pre-CBT-T (1 week before 1st session), mid-CBT-T (post-session 4), post-CBT-T (post session 9), 1-month post-CBT-T, and 3-months post-CBT-T

Primary timepoints: pre-CBT-T and post-CBT-T.

Post-CBT-T is after session 9 as session 10 is relapse prevention.
Secondary outcome [1] 391947 0
Central coherence (Rey Complex Figure Test)
Timepoint [1] 391947 0
Baseline (assessment pre waiting period) and post-treatment (after session 10)
Secondary outcome [2] 391948 0
Set shifting (Wisconsin Card Sorting Test)
Timepoint [2] 391948 0
Baseline (assessment pre waiting period) and post-treatment (after session 10)
Secondary outcome [3] 391949 0
BMI (height measured with a tape measure, weight with a scale - used to calculate BMI)
Timepoint [3] 391949 0
Baseline (assessment pre-waiting period), pre-CBT-T (1 week before 1st session), mid-CBT-T (post-session 4), post-CBT-T (post session 9), 1-month post-CBT-T, and 3-months post-CBT-T
Secondary outcome [4] 391951 0
Clinical impairment (clinical impairment assessment)
Timepoint [4] 391951 0
Baseline (assessment pre-waiting period), pre-CBT-T (1 week before 1st session), mid-CBT-T (post-session 4), post-CBT-T (post session 9), 1-month post-CBT-T, and 3-months post-CBT-T
Post-CBT-T is after session 9 as session 10 is relapse prevention.
Secondary outcome [5] 391952 0
Negative affect (DASS)
Timepoint [5] 391952 0
Baseline (assessment pre-waiting period), pre-CBT-T (1 week before 1st session), mid-CBT-T (post-session 4), post-CBT-T (post session 9), 1-month post-CBT-T, and 3-months post-CBT-T
Post-CBT-T is after session 9 as session 10 is relapse prevention.
Secondary outcome [6] 391953 0
Working alliance (Working Alliance Inventory)
Timepoint [6] 391953 0
Mid-CBT-T (after session 4)
Secondary outcome [7] 391954 0
Motivation (using two questions rated on 10 point Likert scales - 1. How ready are you to change? (0 not at all to 10 very much, and 2. If you decided to change, how confident are you that you would succeed? (0 not at all to 10 very much))
Timepoint [7] 391954 0
Baseline (assessment pre-waiting period), pre-CBT-T (1 week before 1st session), mid-CBT-T (post-session 4), post-CBT-T (post session 9), 1-month post-CBT-T, and 3-months post-CBT-T
Post-CBT-T is after session 9 as session 10 is relapse prevention.

Eligibility
Key inclusion criteria
To be eligible, participants must be at least 15 years old, have a body mass index greater than 18.5, have an eating disorder, and be willing for the therapist to communicate with their GP.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have a severe physical and/or psychiatric condition that would interfere with treatment (e.g. high suicidality, psychosis), if they are already receiving psychotherapy for an eating disorder, if they have difficulty speaking or understanding English, or if they have binge eating disorder (people with binge eating disorder will be directed to self-help material but not offered sessions).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/06/2020
Date of last participant enrolment
Anticipated
1/09/2022
Actual
1/03/2022
Date of last data collection
Anticipated
29/12/2023
Actual
26/06/2022
Sample size
Target
99
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307900 0
University
Name [1] 307900 0
Flinders University
Country [1] 307900 0
Australia
Primary sponsor type
Individual
Name
Ella Keegan
Address
School of Psychology, Flinders University, Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 308614 0
Individual
Name [1] 308614 0
Professor Tracey Wade
Address [1] 308614 0
School of Psychology, Flinders University, Sturt Rd, Bedford Park SA 5042
Country [1] 308614 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307893 0
Social and Behavioural Research Ethics Committee (SBREC)
Ethics committee address [1] 307893 0
Ethics committee country [1] 307893 0
Australia
Date submitted for ethics approval [1] 307893 0
Approval date [1] 307893 0
04/05/2020
Ethics approval number [1] 307893 0
8613

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

Contacts
Principal investigator
Name 108846 0
Ms Ella Keegan
Address 108846 0
School of Psychology, Flinders University, Sturt Rd, Bedford Park SA 5042
Country 108846 0
Australia
Phone 108846 0
+618 82012192
Fax 108846 0
Email 108846 0
[email protected]
Contact person for public queries
Name 108847 0
Ella Keegan
Address 108847 0
School of Psychology, Flinders University, Sturt Rd, Bedford Park SA 5042
Country 108847 0
Australia
Phone 108847 0
+618 82012192
Fax 108847 0
Email 108847 0
[email protected]
Contact person for scientific queries
Name 108848 0
Ella Keegan
Address 108848 0
School of Psychology, Flinders University, Sturt Rd, Bedford Park SA 5042
Country 108848 0
Australia
Phone 108848 0
+618 82012192
Fax 108848 0
Email 108848 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?
Raw individual participant data of primary outcomes
When will data be available (start and end dates)?
Upon study completion with no end date
Available to whom?
All
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Data will be placed on OSF
https://osf.io/


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.