None listed
Conditions
Brief summary
The overall aim of this randomised controlled trial is to evaluate the comparative effectiveness and acceptability of CBT-T for non-underweight clients with EDs aged 15 years and above to CBT-TA. To achieve this, participants will be randomised to either receive CBT-T or CBT-TA. We hypothesise that gradual responders in CBT-TA will have significantly lower disordered eating compared to gradual responders in CBT-T at end of treatment and that these gains will be maintained at the 3- and 6-month follow-up. We also hypothesise that remission will be higher in the former than latter group. We also hypothesise the same advantages for the rapid responder group in CBT-TA over rapid responders in CBT-T. We will also explore (1) change in health service utilisation, (2) engagement and completion data between the two conditions to establish the relative acceptability of the interventions, and (3) client’s experiences of therapy in the form of qualitative feedback.
Interventions
The Ten-session cognitive behaviour Therapy (CBT-T) protocol (described in the manual Brief Cognitive Behavioural Therapy for Non-Underweight Patients: CBT-T for Eating Disorders; Abingdon: Routledge, Taylor & Francis Group) forms the basis of both intervention arms. In brief, CBT- consists of 5 stages: (1) early dietary change and exposure, (2) behavioural experiments relating to food, (3) addressing emotional triggers, (4) body image work, (5) relapse prevention. The intervention comprises of
The Ten-session cognitive behaviour Therapy (CBT-T) protocol (described in the manual Brief Cognitive Behavioural Therapy for Non-Underweight Patients: CBT-T for Eating Disorders; Abingdon: Routledge, Taylor & Francis Group) forms the basis of both intervention arms. In brief, CBT- consists of 5 stages: (1) early dietary change and exposure, (2) behavioural experiments relating to food, (3) addressing emotional triggers, (4) body image work, (5) relapse prevention. The intervention comprises of ten weekly face-to-face 50-minute sessions with a trainee psychologist or clinical psychologist, with each session lasting approximately 50 minutes, delivered at the Flinders University Services for Eating Disorders (FUSED). The CBT-T protocol which describes the structure of each session in detail is available on the CBT-T website: https://cbt-t.sites.sheffield.ac.uk/resources. A further 3 face-to-face follow-up sessions of up to 50 minutes duration are conducted to ensure that progress is maintained – in the current study these will occur at 1-, 3- and 6-months post-treatment. The pre-treatment assessment is designed to encourage change and treatment retention and improve treatment outcome before treatment commences and includes motivational enhancement exercises. In the 2-week period between assessment and the first session of therapy participants will be asked to complete a single session intervention on behavioural activation (https://osf.io/xpqa8/) - a pdf which explores (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, and takes around 30-60 minutes to complete. In CBT-T a review of engagement and progress is routinely conducted in session 4, where those who are not engaging in therapy (e.g., are not actively doing the therapy homework tasks every day between sessions, such as food monitoring, exposure tasks) are invited to step away from treatment until circumstances allow them to fully commit to doing therapy or to have one final attempt to engage by session 5. The number of sessions attended is recorded. Arm 1 (intervention): CBT-T as usual. Arm 2 (comparator): CBT-T augmented (CBT-TA).
Sponsors
Tracey Wade - Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Eligible participants (1) are aged 15 years and over; (2) have any DSM-5 diagnosis of ED as determined by the EDA-5 online clinical interview: https://interview.eda5.org/index.html?t=eyJxIjoiZWRhNSIsIm1ham9yIjoxLCJtaW5vciI6ImN1cnJlbnQiLCJsYW5nIjoiZW4iLCJkZWJ1ZyI6ZmFsc2V9\, excluding anorexia nervosa and avoidant/restrictive feeding intake disorder for which no evidence of the efficacy of CBT-T exists; (3) consent to FUSED communicating regularly with their general practitioner; (4) reside in South Australia; and (5) can read independently at grade 2 level English.
Exclusion criteria
Participants are not eligible if they report current life-threatening suicidal ideation, untreated psychosis, or substance dependence, or have a body mass index (BMI) < 18.5, or currently receiving a psychological therapy for an ED.
Outcome results
None listed