MedDataX Logo

Trial on Three Eating Disorders Group Treatment

NCT ID: NCT05140109

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2022-09-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eating Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive-dissonance based program

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

Group Type EXPERIMENTAL

Arm 1: Cognitive-dissonance based program

Intervention Type OTHER

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

Mindfulness-based program

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

Group Type ACTIVE_COMPARATOR

Arm 2: Mindfulness-based program

Intervention Type OTHER

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

Person-centered program

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

Group Type ACTIVE_COMPARATOR

Arm 3: Person-centered program

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Arm 1: Cognitive-dissonance based program

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

Intervention Type OTHER

Arm 2: Mindfulness-based program

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

Intervention Type OTHER

Arm 3: Person-centered program

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Université Lumière Lyon 2

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

TURGON Roxane

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roxane Turgon

Role: PRINCIPAL_INVESTIGATOR

Université Lumière Lyon 2

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Association Endat

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A02346-33a

Identifier Type: -

Identifier Source: org_study_id