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Trial registered on ANZCTR


Registration number
ACTRN12620000589987
Ethics application status
Approved
Date submitted
17/04/2020
Date registered
21/05/2020
Date last updated
13/10/2020
Date data sharing statement initially provided
21/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Can metacognitive training (MCT) improve treatment outcomes for adolescents with anorexia nervosa?
Scientific title
Can the addition of metacognitive training (MCT) to treatment as usual improve treatment outcomes for adolescents with anorexia nervosa? A pilot randomised controlled trial.
Secondary ID [1] 301043 0
None
Universal Trial Number (UTN)
U1111-1250-5316
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anorexia nervosa 317094 0
Condition category
Condition code
Mental Health 315258 315258 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metacognitive training (MCT) for eating disorders is a brief one-on-one training programme that encourages people to ‘think about their thinking’ (i.e., ‘meta’ means ‘about’ and ‘cognition’ means ‘thinking’). MCT targets ‘thinking errors’ underlying different forms of mental illness and is effective at reducing symptom severity in people with psychosis, depression, borderline personality disorder, and obsessive-compulsive disorder. However, the approach has not yet been applied to people with anorexia nervosa (AN), despite the high prevalence of ‘thinking errors’ in this population (e.g., belief inflexibility; weak central coherence or difficulty seeing the ‘forest for the trees’). MCT may be an particularly beneficial treatment adjunct to adolescents with AN, as it aims to improve cognitive flexibility in a non-confrontational manner by targeting the biased thinking styles that contribute to disordered eating symptoms.

The MCT programme for eating disorders is therapist-led but will be conducted online (via a 'video-chat' interface) and is spread over four modules (two are approximately 30-minutes long and two are approximately 60-minutes long), which will cover some common thinking errors and strategies to reduce them (i.e., belief inflexibility, perfectionism). Each module incorporates several interactive elements, including completing brief exercises (eg, writing your name with your non-dominant hand) or watching short (1-3mins) videos. All interactive elements include the opportunity for personal reflections in the supplied MCT worksheet 'booklet' (created specifically for this study), which participants can complete both within a therapy session or between sessions. Modules conclude with a 'case study' that links the thinking style back to clinically relevant scenarios (eg, consequences of rigid thinking vs. flexible thinking when feeling 'bloated').

The first module serves as an introduction to MCT, focussing on different 'thinking styles' (eg, flexible vs. rigid thinking) and the 'pros' and 'cons' of these. The next module focusses on belief inflexibility, where participants learn about the consequences of rigid thinking and are encouraged to adopt more flexible thinking patterns by practicing short interactive exercises (eg, participants are shown images that require them to 'switch' their interpretation of the image when shown from a different perspective/angle).

The next module focusses on perfectionism, where participants learn about factors that maintain perfectionism, and are encouraged to adopt a less 'perfect' approach when completing interactive exercises (eg, drawing 3 everyday objects with 2 minutes). The final module summaries the main learning outcomes of MCT, and provides strategies on relapse prevention.

Modules will be completed once per week. The online MCT sessions will be delivered by a provisional psychologist, who is a psychology student in their 5th or 6th year of training to become a fully qualified psychologist. The provisional psychologist will receive supervision from two qualified psychologists who will provide regular support and guidance. Adherence to the intervention will be monitored by recording the number of sessions completed (maximum 4).
Intervention code [1] 317349 0
Behaviour
Intervention code [2] 317350 0
Rehabilitation
Comparator / control treatment
Control/waitlist group will receive treatment-as-usual (TAU). TAU is defined as the current treatment regime for the participant, typically psychotherapy, medication, or a combination of the two. Concurrent psychotherapy (eg, CBT) is not an exclusion criterion for this study, given that MCT is an adjunctive training programme.

After the final 3-month follow-up, TAU participants will be provided with the full MCT programme online, but this will be self-paced (not therapist-led).
Control group
Active

Outcomes
Primary outcome [1] 323503 0
Feasibility of MCT for eating disorders in adolescent population, as assessed by a 10-item 5-point Likert scale evaluation questionnaire (eg, 'the sessions were useful and sensible'), with two open-ended qualitative questions gauging feedback for the intervention (specifically 'what worked well' and 'areas that can be improved'). Attrition rate across the treatment phase will also be used to indirectly assess feasibility. Attrition rate will be assessed by an attendance log of the number of sessions completed (maximum 4).
Timepoint [1] 323503 0
4-week follow-up [T2} (post commencement of intervention, T1)
Secondary outcome [1] 382068 0
Body image flexibility, as assessed by the Body Image Acceptance and Action Questionnaire (BI-AAQ).
Timepoint [1] 382068 0
Baseline [T1]; 4-week follow-up [T2] (post commencement of intervention, T1), 3-month follow-up [T3] (post 4-week follow-up, T2)
Secondary outcome [2] 382069 0
Perfectionism, as assessed by Frost Multidimensional Perfectionism Scale (F-MPS).
Timepoint [2] 382069 0
Baseline [T1]; 4-week follow-up [T2] (post commencement of intervention, T1), 3-month follow-up [T3] (post 4-week follow-up, T2)
Secondary outcome [3] 382072 0
Eating disorder cognitions and behaviours, as assessed by the composite 'ED-15' measure.
Timepoint [3] 382072 0
Baseline [T1]; 4-week follow-up [T2] (post commencement of intervention, T1), 3-month follow-up [T3] (post 4-week follow-up, T2)
Secondary outcome [4] 382074 0
Cognitive biases, assessed by the Beads Task (jumping to conclusions bias) and BADE task (belief flexibility).
Timepoint [4] 382074 0
Baseline [T1]; 4-week follow-up [T2] (post commencement of intervention, T1), 3-month follow-up [T3] (post 4-week follow-up, T2)
Secondary outcome [5] 382076 0
Anxiety symptoms as assessed by the DASS-21.
Timepoint [5] 382076 0
Baseline [T1]; 4-week follow-up [T2] (post commencement of intervention, T1), 3-month follow-up [T3] (post 4-week follow-up, T2)
Secondary outcome [6] 382750 0
Depression symptoms as assessed by the DASS-21.
Timepoint [6] 382750 0
Baseline [T1]; 4-week follow-up [T2] (post commencement of intervention, T1), 3-month follow-up [T3] (post 4-week follow-up, T2)

Eligibility
Key inclusion criteria
Patients to be aged between 14 and 17 years and have a diagnosis of anorexia nervosa (including atypical).
Minimum age
14 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if deemed to be medically unfit for participation by their medical treatment team.

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 to active/control group will be by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Baseline assessment is blinded by the participant and therapist/researcher, as group allocation to active or wait-list control occurs after this assessment. The initial follow-up (T2) and 3-month follow-up (T3) are not blinded to the participant or therapist/researcher.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Although a power analysis suggests that 42 participants per group would be required to detect moderate-sized group differences (g = 0.41) at follow-up assessment, the present trial is a preliminary pilot study into the feasibility and effectiveness of MCT for adolescents with AN, and the estimated final sample size of 40 participants is consistent with similar feasibility trials.

It is proposed that repeated-measures analysis-of-variance (RM-ANOVA) inferential statistics will be employed to test the hypotheses on the various measures between the MCT and control groups pre- and post-treatment.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16493 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 30043 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 305481 0
Charities/Societies/Foundations
Name [1] 305481 0
Channel 7 Children's Research Foundation
Address [1] 305481 0
PO Box 2438
Regency Park SA 5942
Country [1] 305481 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide 5001, South Australia
Country
Australia
Secondary sponsor category [1] 305880 0
None
Name [1] 305880 0
Address [1] 305880 0
Country [1] 305880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305798 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 305798 0
72 King William Rd
North Adelaide SA 5006
Ethics committee country [1] 305798 0
Australia
Date submitted for ethics approval [1] 305798 0
03/05/2019
Approval date [1] 305798 0
16/10/2019
Ethics approval number [1] 305798 0
HREC/19/WCHN/107

Summary
Brief summary
Metacognitive training (MCT) targets ‘thinking errors’ underlying different forms of mental illness and is effective at reducing symptom severity in people with psychosis, depression, borderline personality disorder, and obsessive-compulsive disorder. Importantly, the literature suggests that MCT is not only effective at reducing the severity of a diverse range of psychiatric symptoms (e.g., delusions, depressed mood, compulsive thoughts), but that participants consistently report that the training is engaging, with high applicability to daily life and low attrition rates.

However, the approach has not yet been applied to people with anorexia nervosa (AN), despite the high prevalence of ‘thinking errors’ in this population (e.g., belief inflexibility; weak central coherence or difficulty seeing the ‘forest for the trees’). MCT may be particularly beneficial to adolescents with AN, as it aims to improve cognitive flexibility in a non-confrontational manner by targeting the biased thinking styles that contribute to disordered eating symptoms.

This project, the first randomised controlled trial to investigate MCT in individuals with eating disorders, specially aims to:

1) determine the feasibility of the MCT programme for adolescents with anorexia nervosa (e.g., subjective evaluation of the programme’s effectiveness and applicability to daily life).

2) determine the therapeutic benefit of MCT for adolescents with AN when added to an inpatient refeeding program, including eating disorder symptom severity (e.g., concerns about weight, shape, and eating).

3) generate knowledge of the psychological processes that contribute to the onset and maintenance of AN (e.g., belief inflexibility, perfectionism). By developing a greater understanding of the psychological processes responsible for disordered eating, this project is expected to improve current models for preventing and treating this serious mental health condition.

As the study is a feasibility trial, we are primarily interested in the qualitative feedback participants in the MCT condition provide. We are also interested in group (MCT/control) differences across several secondary measures. We hypothesise that the MCT group will experience greater improvements on biased thinking styles associated with eating disorders (e.g., improved cognitive flexibility, lower perfectionism) and greater increases in global eating disorder psychopathology than the control group at 3-month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101630 0
Dr Ryan Balzan
Address 101630 0
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, 5001, South Australia
Country 101630 0
Australia
Phone 101630 0
+61 08 8201 3082
Fax 101630 0
Email 101630 0
ryan.balzan@flinders.edu.au
Contact person for public queries
Name 101631 0
Dr Ryan Balzan
Address 101631 0
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, 5001, South Australia
Country 101631 0
Australia
Phone 101631 0
+61 08 8201 3082
Fax 101631 0
Email 101631 0
ryan.balzan@flinders.edu.au
Contact person for scientific queries
Name 101632 0
Dr Ryan Balzan
Address 101632 0
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, 5001, South Australia
Country 101632 0
Australia
Phone 101632 0
+61 08 8201 3082
Fax 101632 0
Email 101632 0
ryan.balzan@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Feasibility/pilot trial
What supporting documents are/will be available?
No other documents available
Summary results
No Results