NCT05746364

Brief Summary

Eating Disorders (ED) are mental health conditions where people alter food intake in some way to help with weight gain, managing emotions or other situations. EDs are increasingly common in young people. They can cause both the young person and those around them significant distress. Talking therapies can help. Cognitive Analytic Therapy (CAT) is a talking therapy that is becoming increasingly widely used within the NHS to help with a wide range of problems. CAT focuses on the relationships clients have with themselves and others around them. From CAT, we have developed Relational Intervention for Difficulties with Eating (RIDE), This is a brief talking therapy. The aim is to help the young person and those around them build an understanding of their difficulties. This will hopefully mean others can support them with their disordered eating. The aim of the study is to examine the feasibility (is it possible to conduct a study about this intervention?) and acceptability (do participants find the therapy is helpful and makes sense to them?) of RIDE. As a secondary aim, the study will look at whether RIDE shows preliminary evidence for positive change on relevant measures of psychological difficulties (e.g. distress, how young people feel about themselves and others). The study will aim to recruit nine young people (aged between 14-25) with ED. Participants must be under the care of an ED service. They will attend 8 appointments (3 assessment, 5 therapy) either at their home, University of Manchester campus or a health service clinic. A video conferencing platform (e.g. Zoom, Teams) can be used if required. Participants will complete questionnaires before, during and after therapy. The findings will help to develop the therapy and improve further testing in larger studies. If successful, RIDE could be available as a treatment for young people.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

February 6, 2023

Last Update Submit

August 6, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Retention rate of participants at all five intervention sessions

    At least 70% of those recruited will attend all 5 intervention sessions.

    12 months

  • Number of eligible referrals that consent to participate

    Over 50% of those who are referred to the study and are eligible to participate, will consent to take part in the study.

    12 months

  • Proportion of missing data across outcome assessments

    The level of missing data on clinical outcome measures at assessments (for those still retained in the study) does not exceed 20% per assessment

    12 months

  • Adapted Experiences of Services Questionnaire

    Adapted Experiences of Services Questionnaire measures satisfaction with experiences of therapy and will be used to gain feedback and measure aspects of the acceptability of the intervention. Seven items are rated on 0 to 3 scale, With higher item scores indicating greater satisfaction with therapy.

    post-treatment (8 weeks).

Secondary Outcomes (5)

  • The Eating Disorder Examination Questionnaire (EDE-Q)

    post-treatment (8 weeks).

  • The Young Person's Clinical Outcome in Routine Evaluation (YP-CORE)

    post-treatment (8 weeks). Follow-up (10 weeks)

  • Recovery Questionnaire (ReQuest-YP)

    post-treatment (8 weeks). Follow-up (10 weeks)

  • University of Rode Island Change Assessment Scale (URICA)

    post-treatment (8 weeks). Follow-up (10 weeks)

  • Repertory grid

    post-treatment (8 weeks)

Study Arms (1)

RIDE intervention

EXPERIMENTAL

Cognitive analytic therapy (CAT)-informed brief therapy for young people struggling with disordered eating

Behavioral: Brief CAT-Informed Intervention for Young People experiencing Difficulties with Eating

Interventions

The therapy draws upon the principles of Cognitive Analytic Therapy (CAT), focussing on collaboratively identifying relational patterns (relationships with self and others) that young people experience difficulties with. The young person will be invited to attend 5 weekly sessions, each lasting 30-50 minutes. It will be delivered within a seven-week window (allowing for cancellations/missed sessions). Researchers will follow the RIDE manual treatment guide, which was developed by Clinical Psychologists, CAT accredited therapists and researchers.

RIDE intervention

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants will be between the ages of 14 - 25 years.
  • Participants will be under the care of a mental health team and have a clinician allocated to them within local ED Services.

You may not qualify if:

  • Young people will be excluded if they are currently receiving alternative one-to-one psychological therapy (not including family interventions or skill-based groups).
  • Young people will be excluded if they have a moderate to severe intellectual disability which would impair their ability to participate without considerable adaptations being made to the intervention, as judged by the young person or the clinical team.
  • Young people will be excluded if they have inadequate English-language speaking skills due to limitations in their ability to engage with talking therapies in the English language.
  • Young people will be excluded if they are judged at high risk of harm to themselves, operationalised as having current suicidal thoughts with a high intent or active plan to end their life. This includes individuals who are deemed at risk of harm to themselves by the clinical team due to a sustained trajectory of recent weight loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greater Manchester Mental Health NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

  • Green C, Mannion G, Gill I, Hartley S, Dunlop BJ, Taylor PJ. Brief Cognitive Analytic Therapy (CAT)-Informed Reformulation for Young People With Eating Disorders: A Case Series. Clin Psychol Psychother. 2025 Mar-Apr;32(2):e70043. doi: 10.1002/cpp.70043.

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Eating

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior clinical lecturer

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 27, 2023

Study Start

May 1, 2023

Primary Completion

January 20, 2024

Study Completion

August 1, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Given the small scale of the project there is no plan to make data available via online repositories. Anonymised data may be made available to other researchers on reasonable request.

Locations