Trial on Three Eating Disorders Group Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Eating Disorders

Intervention / Treatment
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* Other: Arm 1: Cognitive-dissonance based program
* Other: Arm 2: Mindfulness-based program
* Other: Arm 3: Person-centered program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |