Trial on Three Eating Disorders Group Treatment

Not Applicable

Completed

• Conditions: Eating Disorders

• Registration Number: NCT05140109
• Lead Sponsor: Université Lumière Lyon 2

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2021-01-29
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-12-01
• Study Completion: 2022-09-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change in The Eating Disorders Diagnostic Interview from pretest to 1-year follow-up	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

Name	Time	Method
Mean change in the subscale "Body dissatisfaction" from the scale Eating disorders inventory-2 from pretest to 1-year follow-up	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 World Health Organization Quality Of Life Scale from pretest to 1-year follow-up	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	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	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.
Mean change in the Sociocultural Attitudes Towards Appearance Scale from pretest to 1-year follow-up	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 Hospital Anxiety and Depression Scale from pretest to 1-year follow-up	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.

Trial Locations

Locations (1)

Association Endat; 🇫🇷 Paris, France