Trial on Three Eating Disorders Group Treatment

NCT05140109 | Completed

• 1 other identifier: 2020-A02346-33a
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean change in The Hospital Anxiety and Depression Scale from pretest to 1-year follow-up

  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

  From pretest to 1-year follow-up

• Mean change in the Sociocultural Attitudes Towards Appearance Scale from pretest to 1-year follow-up

  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

  From pretest to 1-year follow-up

• Mean change in the Strathclyde Inventory measuring congruence from pretest to 1-year follow-up

  From pretest to 1-year follow-up

Other Outcomes (9)

• Presence or absence of ancillary treatment at 3-months follow-up

  At 3-months follow-up and 1-year follow-up

• Demographic data (age) at pretest

  At pretest

• Demographic data (socio-professional status) at pretest

  At pretest

Study Arms (3)

Cognitive-dissonance based program

EXPERIMENTAL

Group program of 8 sessions of one hour and a half.

Other: Arm 1: Cognitive-dissonance based program

Mindfulness-based program

ACTIVE COMPARATOR

Group program of 8 sessions of one hour and a half.

Other: Arm 2: Mindfulness-based program

Person-centered program

ACTIVE COMPARATOR

Group program of 8 sessions of one hour and a half.

Other: Arm 3: Person-centered program

Interventions

Arm 1: Cognitive-dissonance based program OTHER

The first four sessions focus on body image and the last four sessions on eating behavior.

Cognitive-dissonance based program

Arm 2: Mindfulness-based program OTHER

The sessions focus on different contents as body image, eating behavior and emotion regulation.

Mindfulness-based program

Arm 3: Person-centered program OTHER

The sessions are not structured. Participants can bring any subject they need to talk.

Person-centered program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• a psychotic disorder
• a bipolar disorder
• a mental retardation
• to not read or speak French fluently

Sponsors & Collaborators

• Université Lumière Lyon 2: lead

Study Sites (1)

Association Endat

Paris, 75015, France

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Roxane Turgon

  Université Lumière Lyon 2

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 1, 2021
• Study Start: September 1, 2018
• Primary Completion: January 29, 2021
• Study Completion: September 22, 2022
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)