Trial on Three Eating Disorders Group Treatment

Eating Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05140109
• Other study ID #: 2020-A02346-33a
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 22, 2022

Study information

• Verified date: November 2021
• Source: University Grenoble Alps
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 22, 2022
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eating Disorders
• Feeding and Eating Disorders

Intervention

Other:
• Arm 1: Cognitive-dissonance based program
The first four sessions focus on body image and the last four sessions on eating behavior.
• Arm 2: Mindfulness-based program
The sessions focus on different contents as body image, eating behavior and emotion regulation.
• Arm 3: Person-centered program
The sessions are not structured. Participants can bring any subject they need to talk.

Locations

Country	Name	City	State
France	Association Endat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence or absence of ancillary treatment at 3-months follow-up		At 3-months follow-up
Other	Demographic data (age) at pretest		At pretest
Other	Demographic data (socio-professional status) at pretest		At pretest
Other	Demographic data (marital status) at pretest		At pretest
Other	Demographic data (education level) at pretest		At pretest
Other	Demographic data (Body Mass Index) at pretest		At pretest
Other	Demographic data (duration of eating disorders symptoms) at pretest		At pretest
Other	Demographic data (treatment medical history for eating disorders symptoms) at pretest		At pretest
Other	Demographic data (traumatic medical history) at pretest		At pretest
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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