ANZCTR - Registration

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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

3/02/2023

Date data sharing statement initially provided

21/05/2020

Date results provided

3/02/2023

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]

None

Universal Trial Number (UTN)

U1111-1250-5316

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

anorexia nervosa

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

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]

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]

4-week follow-up [T2} (post commencement of intervention, T1)

Secondary outcome [1]

Body image flexibility, as assessed by the Body Image Acceptance and Action Questionnaire (BI-AAQ).

Timepoint [1]