Trial on Three Eating Disorders Group Treatment

Effectiveness Randomized Controlled Trial on Eating Disorders Group Treatment: a Cognitive Dissonance, a Mindfulness and a Person-centered Based Program

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.

Study Overview

• Status: Completed
• Conditions: Eating Disorders
• Intervention / Treatment: Other: Arm 1: Cognitive-dissonance based program; Other: Arm 2: Mindfulness-based program; Other: Arm 3: Person-centered program

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Association Endat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-dissonance based program; Group program of 8 sessions of one hour and a half.	Other: Arm 1: Cognitive-dissonance based program; The first four sessions focus on body image and the last four sessions on eating behavior.
Active Comparator: Mindfulness-based program; Group program of 8 sessions of one hour and a half.	Other: Arm 2: Mindfulness-based program; The sessions focus on different contents as body image, eating behavior and emotion regulation.
Active Comparator: Person-centered program; Group program of 8 sessions of one hour and a half.	Other: Arm 3: Person-centered program; The sessions are not structured. Participants can bring any subject they need to talk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From pretest to 1-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From pretest to 1-year follow-up
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.	From pretest to 1-year follow-up
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.	From pretest to 1-year follow-up
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.	From pretest to 1-year follow-up
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.	From pretest to 1-year follow-up
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.	From pretest to 1-year follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of ancillary treatment at 3-months follow-up	A YES/NO answer	At 3-months follow-up and 1-year follow-up
Demographic data (age) at pretest	Current age of the participant	At pretest
Demographic data (socio-professional status) at pretest	Current job of the participant	At pretest
Demographic data (marital status) at pretest	Current marital status of the participnat	At pretest
Demographic data (education level) at pretest	Educational degree of the participant	At pretest
Demographic data (Body Mass Index) at pretest	Current height and weight of the participant	At pretest
Demographic data (duration of eating disorders symptoms) at pretest	Number of years since the first symptoms of eating disorders	At pretest
Demographic data (treatment medical history for eating disorders symptoms) at pretest	Names of treatment done in the past	At pretest
Demographic data (traumatic medical history) at pretest	A YES/NO questionnaires on potential traumatic events	At pretest

Collaborators and Investigators

• Sponsor: Université Lumière Lyon 2
• Investigators: Principal Investigator: Roxane Turgon, Université Lumière Lyon 2

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): January 29, 2021
• Study Completion (Actual): September 22, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 2020-A02346-33a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No