Clinical trial NCT05140109: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Lead sponsor: Université Lumière Lyon 2
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean change in The Eating Disorders Diagnostic Interview from pretest to 1-year follow-up
timeFrame: From pretest to 1-year follow-up
Secondary outcomes:
measure: Mean change in The Hospital Anxiety and Depression Scale from pretest to 1-year follow-up
timeFrame: From pretest to 1-year follow-up
measure: Mean change in the subscale "Body dissatisfaction" from the scale Eating disorders inventory-2 from pretest to 1-year follow-up
timeFrame: From pretest to 1-year follow-up
measure: Mean change in the Sociocultural Attitudes Towards Appearance Scale from pretest to 1-year follow-up
timeFrame: From pretest to 1-year follow-up
measure: Mean change in the World Health Organization Quality Of Life Scale from pretest to 1-year follow-up
timeFrame: From pretest to 1-year follow-up
measure: Mean change in the Strathclyde Inventory measuring congruence from pretest to 1-year follow-up
timeFrame: From pretest to 1-year follow-up
measure: Mean change in the Equanimity scale from pretest to 1-year follow-up
timeFrame: From pretest to 1-year follow-up
Other outcomes:
measure: Presence or absence of ancillary treatment at 3-months follow-up
timeFrame: At 3-months follow-up and 1-year follow-up
measure: Demographic data (age) at pretest
timeFrame: At pretest
measure: Demographic data (socio-professional status) at pretest
timeFrame: At pretest
measure: Demographic data (marital status) at pretest
timeFrame: At pretest
measure: Demographic data (education level) at pretest
timeFrame: At pretest
measure: Demographic data (Body Mass Index) at pretest
timeFrame: At pretest
measure: Demographic data (duration of eating disorders symptoms) at pretest
timeFrame: At pretest
measure: Demographic data (treatment medical history for eating disorders symptoms) at pretest
timeFrame: At pretest
measure: Demographic data (traumatic medical history) at pretest
timeFrame: At pretest
Locations:
city: Paris
country: France
facility: Association Endat
Study officials:
affiliation: Université Lumière Lyon 2
name: Roxane Turgon
role: PRINCIPAL_INVESTIGATOR
References: