Trial on Three Eating Disorders Group Treatment
Primary Purpose
Eating Disorders
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Arm 1: Cognitive-dissonance based program
Arm 2: Mindfulness-based program
Arm 3: Person-centered program
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders
Eligibility Criteria
Inclusion Criteria:
- eating disorders (anorexia nervosa, bulimia nervosa or binge eating disorder) or other specified feeding or eating disorder (subthreshold of anorexia, bulimia or binge eating disorder) according to Diagnostic Statistical Manual 5
- to have no regular treatment (no more than one session per month) during the 8 weeks of the program
- participants with a Body Mass Index under 17.5 could be include in the study if they had a medical monitoring in another structure
Exclusion Criteria:
- a psychotic disorder
- a bipolar disorder
- a mental retardation
- to not read or speak French fluently
Sites / Locations
- Association Endat
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Cognitive-dissonance based program
Mindfulness-based program
Person-centered program
Arm Description
Group program of 8 sessions of one hour and a half.
Group program of 8 sessions of one hour and a half.
Group program of 8 sessions of one hour and a half.
Outcomes
Primary Outcome Measures
Mean change in The Eating Disorders Diagnostic Interview from pretest to 1-year follow-up
The minimum of the scale is 0 and the maximum is 276. A higher score means a worse outcome.
Secondary Outcome Measures
Mean change in The Hospital Anxiety and Depression Scale from pretest to 1-year follow-up
The minimum of the scale is 0 and the maximum is 42. A higher score means a worse outcome.
Mean change in the subscale "Body dissatisfaction" from the scale Eating disorders inventory-2 from pretest to 1-year follow-up
The minimum of the scale is 0 and the maximum is 27. A higher score means a worse outcome.
Mean change in the Sociocultural Attitudes Towards Appearance Scale from pretest to 1-year follow-up
The minimum of the scale is 0 and the maximum is 150. A higher score means a worse outcome.
Mean change in the World Health Organization Quality Of Life Scale from pretest to 1-year follow-up
The minimum of the scale is 0 and the maximum is 20. A higher score means a better outcome.
Mean change in the Strathclyde Inventory measuring congruence from pretest to 1-year follow-up
The minimum of the scale is 0 and the maximum is 4. A higher score means a better outcome.
Mean change in the Equanimity scale from pretest to 1-year follow-up
The minimum of the scale is 0 and the maximum is 7. A higher score means a better outcome.
Full Information
NCT ID
NCT05140109
First Posted
November 5, 2021
Last Updated
November 17, 2021
Sponsor
University Grenoble Alps
1. Study Identification
Unique Protocol Identification Number
NCT05140109
Brief Title
Trial on Three Eating Disorders Group Treatment
Official Title
Effectiveness Randomized Controlled Trial on Eating Disorders Group Treatment: a Cognitive Dissonance, a Mindfulness and a Person-centered Based Program
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
January 29, 2021 (Actual)
Study Completion Date
September 22, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Grenoble Alps
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
This trial aims at comparing three group treatments designed for eating disorders: a Cognitive-dissonance, a Mindfulness and a Person-centered based programs. Women with eating disorders will be recruited and randomized to one of the three programs. Participants will complete a pretest, a posttest, a 3-months follow-up and a 1-year follow-up. This trial aims to compare the programs to analyze the specific dimensions upon which each program acts. The investigators therefore made hypotheses according to the programs' theory: participants in the Cognitive-dissonance based program should experience a greater decrease in eating disorders symptoms, thin-ideal internalization and body dissatisfaction and a greater improvement in quality of life than other participants. Participants in the Mindfulness-based program should show a greater improvement in negative affect and in equanimity than other participants. Participants in the Person-Centered based program should report a greater increase in congruence than other participants.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-dissonance based program
Arm Type
Experimental
Arm Description
Group program of 8 sessions of one hour and a half.
Arm Title
Mindfulness-based program
Arm Type
Active Comparator
Arm Description
Group program of 8 sessions of one hour and a half.
Arm Title
Person-centered program
Arm Type
Active Comparator
Arm Description
Group program of 8 sessions of one hour and a half.
Intervention Type
Other
Intervention Name(s)
Arm 1: Cognitive-dissonance based program
Intervention Description
The first four sessions focus on body image and the last four sessions on eating behavior.
Intervention Type
Other
Intervention Name(s)
Arm 2: Mindfulness-based program
Intervention Description
The sessions focus on different contents as body image, eating behavior and emotion regulation.
Intervention Type
Other
Intervention Name(s)
Arm 3: Person-centered program
Intervention Description
The sessions are not structured. Participants can bring any subject they need to talk.
Primary Outcome Measure Information:
Title
Mean change in The Eating Disorders Diagnostic Interview from pretest to 1-year follow-up
Description
The minimum of the scale is 0 and the maximum is 276. A higher score means a worse outcome.
Time Frame
From pretest to 1-year follow-up
Secondary Outcome Measure Information:
Title
Mean change in The Hospital Anxiety and Depression Scale from pretest to 1-year follow-up
Description
The minimum of the scale is 0 and the maximum is 42. A higher score means a worse outcome.
Time Frame
From pretest to 1-year follow-up
Title
Mean change in the subscale "Body dissatisfaction" from the scale Eating disorders inventory-2 from pretest to 1-year follow-up
Description
The minimum of the scale is 0 and the maximum is 27. A higher score means a worse outcome.
Time Frame
From pretest to 1-year follow-up
Title
Mean change in the Sociocultural Attitudes Towards Appearance Scale from pretest to 1-year follow-up
Description
The minimum of the scale is 0 and the maximum is 150. A higher score means a worse outcome.
Time Frame
From pretest to 1-year follow-up
Title
Mean change in the World Health Organization Quality Of Life Scale from pretest to 1-year follow-up
Description
The minimum of the scale is 0 and the maximum is 20. A higher score means a better outcome.
Time Frame
From pretest to 1-year follow-up
Title
Mean change in the Strathclyde Inventory measuring congruence from pretest to 1-year follow-up
Description
The minimum of the scale is 0 and the maximum is 4. A higher score means a better outcome.
Time Frame
From pretest to 1-year follow-up
Title
Mean change in the Equanimity scale from pretest to 1-year follow-up
Description
The minimum of the scale is 0 and the maximum is 7. A higher score means a better outcome.
Time Frame
From pretest to 1-year follow-up
Other Pre-specified Outcome Measures:
Title
Presence or absence of ancillary treatment at 3-months follow-up
Time Frame
At 3-months follow-up
Title
Demographic data (age) at pretest
Time Frame
At pretest
Title
Demographic data (socio-professional status) at pretest
Time Frame
At pretest
Title
Demographic data (marital status) at pretest
Time Frame
At pretest
Title
Demographic data (education level) at pretest
Time Frame
At pretest
Title
Demographic data (Body Mass Index) at pretest
Time Frame
At pretest
Title
Demographic data (duration of eating disorders symptoms) at pretest
Time Frame
At pretest
Title
Demographic data (treatment medical history for eating disorders symptoms) at pretest
Time Frame
At pretest
Title
Demographic data (traumatic medical history) at pretest
Time Frame
At pretest
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
eating disorders (anorexia nervosa, bulimia nervosa or binge eating disorder) or other specified feeding or eating disorder (subthreshold of anorexia, bulimia or binge eating disorder) according to Diagnostic Statistical Manual 5
to have no regular treatment (no more than one session per month) during the 8 weeks of the program
participants with a Body Mass Index under 17.5 could be include in the study if they had a medical monitoring in another structure
Exclusion Criteria:
a psychotic disorder
a bipolar disorder
a mental retardation
to not read or speak French fluently
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roxane Turgon
Organizational Affiliation
Université Grenoble-Alpes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Association Endat
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Trial on Three Eating Disorders Group Treatment
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