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Case-Series Examination of a Brief CAT-Informed Intervention for Young People Experiencing Difficulties With Eating (RIDE) (RIDE)

Primary Purpose

Eating Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Brief CAT-Informed Intervention for Young People experiencing Difficulties with Eating
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders

Eligibility Criteria

14 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Greater Manchester Mental Health NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RIDE intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Retention rate of participants at all five intervention sessions
At least 70% of those recruited will attend all 5 intervention sessions.
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.
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
Client Experience Questionnaire (CEQ)
The Client Experience Questionnaire (CEQ) 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 2 scale, With scores ranging from 0 to 14, higher scores indicating greater satisfaction with therapy.

Secondary Outcome Measures

The Eating Disorder Examination Questionnaire (EDE-Q)
A 28-item self-reported questionnaire adapted from the semi-structured interview Eating Disorder Examination (EDE) and designed to assess the range and severity of features associated with a diagnosis of eating disorder using 4 subscales (Restraint, Eating Concern, Shape Concern and Weight Concern) and a global score. For each subscale scores range from 0 to 6, with higher scores indicating greater difficulties.
The Young Person's Clinical Outcome in Routine Evaluation (YP-CORE)
A 10-item questionnaire that measures psychological distress in young people. An evaluation of the YP-CORE showed good internal reliability and reliable change indices. Scorers range from 0 to 40, with higher scores indicating greater difficulties.
Recovery Questionnaire (ReQuest-YP)
Examines recovery of functionality and outlook post-treatment. An evaluation of the psychometric properties of the ReQuest-YP with 65 young people showed good internal consistency and test-retest reliability. Scores range from 0 to 90, with higher scores indicating greater recovery.
University of Rode Island Change Assessment Scale (URICA)
Examines a person's motivation to change in relation to a specific 'problem'. It is a 32-item self-report measure that includes 4 subscales to measure what stage of change the individual is currently in: Precontemplation, Contemplation, Action, and Maintenance. The scale consists of 4 subscales, each with scores ranging from 1 to 5, greater scores indicating greater motivation for change.
Repertory grid
Repertory grids are a type of interview tool which will be used to explore how participants perceive themselves and others in their lives. This will be developed with the participant prior to the intervention, to get a sense of their relational patterns at baseline. The grid will be developed using established techniques. Participants will then complete the same grid following the intervention to explore any changes in their perceptions of themselves and others.

Full Information

First Posted
February 6, 2023
Last Updated
May 9, 2023
Sponsor
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT05746364
Brief Title
Case-Series Examination of a Brief CAT-Informed Intervention for Young People Experiencing Difficulties With Eating (RIDE)
Acronym
RIDE
Official Title
Case-Series Examination of a Brief CAT-Informed Intervention for Young People Experiencing Difficulties With Eating (RIDE)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 7 appointments (2 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIDE intervention
Arm Type
Experimental
Arm Description
Cognitive analytic therapy (CAT)-informed brief therapy for young people struggling with disordered eating
Intervention Type
Behavioral
Intervention Name(s)
Brief CAT-Informed Intervention for Young People experiencing Difficulties with Eating
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention rate of participants at all five intervention sessions
Description
At least 70% of those recruited will attend all 5 intervention sessions.
Time Frame
12 months
Title
Number of eligible referrals that consent to participate
Description
Over 50% of those who are referred to the study and are eligible to participate, will consent to take part in the study.
Time Frame
12 months
Title
Proportion of missing data across outcome assessments
Description
The level of missing data on clinical outcome measures at assessments (for those still retained in the study) does not exceed 20% per assessment
Time Frame
12 months
Title
Client Experience Questionnaire (CEQ)
Description
The Client Experience Questionnaire (CEQ) 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 2 scale, With scores ranging from 0 to 14, higher scores indicating greater satisfaction with therapy.
Time Frame
post-treatment (8 weeks).
Secondary Outcome Measure Information:
Title
The Eating Disorder Examination Questionnaire (EDE-Q)
Description
A 28-item self-reported questionnaire adapted from the semi-structured interview Eating Disorder Examination (EDE) and designed to assess the range and severity of features associated with a diagnosis of eating disorder using 4 subscales (Restraint, Eating Concern, Shape Concern and Weight Concern) and a global score. For each subscale scores range from 0 to 6, with higher scores indicating greater difficulties.
Time Frame
post-treatment (8 weeks).
Title
The Young Person's Clinical Outcome in Routine Evaluation (YP-CORE)
Description
A 10-item questionnaire that measures psychological distress in young people. An evaluation of the YP-CORE showed good internal reliability and reliable change indices. Scorers range from 0 to 40, with higher scores indicating greater difficulties.
Time Frame
post-treatment (8 weeks). Follow-up (10 weeks)
Title
Recovery Questionnaire (ReQuest-YP)
Description
Examines recovery of functionality and outlook post-treatment. An evaluation of the psychometric properties of the ReQuest-YP with 65 young people showed good internal consistency and test-retest reliability. Scores range from 0 to 90, with higher scores indicating greater recovery.
Time Frame
post-treatment (8 weeks). Follow-up (10 weeks)
Title
University of Rode Island Change Assessment Scale (URICA)
Description
Examines a person's motivation to change in relation to a specific 'problem'. It is a 32-item self-report measure that includes 4 subscales to measure what stage of change the individual is currently in: Precontemplation, Contemplation, Action, and Maintenance. The scale consists of 4 subscales, each with scores ranging from 1 to 5, greater scores indicating greater motivation for change.
Time Frame
post-treatment (8 weeks). Follow-up (10 weeks)
Title
Repertory grid
Description
Repertory grids are a type of interview tool which will be used to explore how participants perceive themselves and others in their lives. This will be developed with the participant prior to the intervention, to get a sense of their relational patterns at baseline. The grid will be developed using established techniques. Participants will then complete the same grid following the intervention to explore any changes in their perceptions of themselves and others.
Time Frame
post-treatment (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Taylor, ClinPsyD
Phone
+44(0)1612758589
Email
peter.taylor-2@manchester.ac.uk
Facility Information:
Facility Name
Greater Manchester Mental Health NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Taylor
Phone
+441612758589
Email
peter.taylor-2@manchester.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

Case-Series Examination of a Brief CAT-Informed Intervention for Young People Experiencing Difficulties With Eating (RIDE)

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