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Trial registered on ANZCTR

Registration number

ACTRN12623000101684

Ethics application status

Approved

Date submitted

16/01/2023

Date registered

27/01/2023

Date last updated

27/01/2023

Date data sharing statement initially provided

27/01/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Evaluation of different approaches to helping people get more out of therapy for non-underweight eating disorders

Scientific title

An adaptive trial design evaluating use of varying wait lists on the severity of disordered eating in people with non-underweight eating disorders

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1287-1029

Trial acronym

Preparing Ourselves With Early changes to Restriction (POWER)

Linked study record

Health condition

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

eating disorders

Condition category

Condition code

Mental Health

Eating disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The initial 90-minute semi-structured interview assessment will be conducted at the Flinders University Services for Eating Disorders clinic by a trainee psychologist. The assessment follows a semi-structured outline, and includes 4 motivational aspects: (1) examining the pros and cons of the eating disorder, (2) examining readiness and confidence to change and barriers to having higher ratings, (3) development of a personalised vicious cycle, and (4) examination of the advantages of change, fears about change, and responses to these fears. The interventions are described and the patient is asked whether they wish to commit to the treatment.

People who are suitable and interested to progress will be randomised to one of three 2-week wait-list conditions, single session interventions (SSI) informed by work from Jessica Schleider’s laboratory: growth mindset, behavioural activation and non-suicidal self-injury. All of the SSIs are contained in word documents that the person can do online or in hard copy, and include information and interactive exercises. Participants will be asked to spend 1 hour at the beginning of the 2-week waitlist completing the SSI. Compliance will be assessed using one question about how much was read at the second assessment, and also by the therapist asking them to discuss the last exercise in the SSI with them. The growth mindset SSI contains information about how we can shape our thoughts and feelings by changing our behaviours and the connections in our brains and the importance of nutrition in allowing the brain to adapt. The behavioural activation SSI discusses 4 actions that can improve mood: (1) Connecting with people who make you feel good; (2) Achieving goals that matter to you; (3) Enjoying activities on your own; (4) Feeding your brain. The non suicidal self-injury SSI discusses techniques for ceasing cease self-harming behaviours.

Those participants who decrease restriction (assessed using the dietary restriction subscale of the Eating Disorder Examination Questionnaire) by 30% at the end of the 2-week waitlist will be allocated to an online guided 10-session CBT-ED delivered weekly with therapist contact for 30-50 minutes each week. Those who show less response will be allocated face-to-face 10-session CBT-T, offered weekly for 50 minutes each session. The main difference between these two forms of CBT are that CBT-T includes a large component of body image work, while the online CBT focuses more on time on motivation. This approach is informed by a very consistent and large body of research showing that early response is the strongest and most consistent predictor of good outcome, and that people with non-underweight eating disorders who experience this early change do well with guided self-help CBT-ED.

For each form of CBT the therapist is a postgraduate Clinical Psychology trainee, provisionally registered. Adherence to sessions will be monitored by attendance at sessions, whether online or face-to-face.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

The waitlist has three conditions: growth mindset, behavioural activation and tackling non-suicidal self-injury. The first two conditions are intervention conditions as they overtly discuss dietary restriction while the non-suicidal self-injury condition does not and thus is the active control condition.
Subsequent allocation to one of two conditions depends on response to these conditions. Those participants who decrease restriction by 30% at the end of the 2-week waitlist will be allocated to an online guided 8-session CBT-ED. Those who show less response will be allocated face-to-face 10-session CBT-T.

Control group

Active

Outcomes

Primary outcome [1]

Eating Disorder Examination Questionnaire - Global score

Timepoint [1]

24-weeks post-initial assessment

Secondary outcome [1]

Eating Disorder 15 assessing severity of body image disturbance and frequency of binge eating, restriction, laxative or diuretic use, driven exercising.

Timepoint [1]