Skip to main content
OpenTrials
Completed

NCT Number: NCT05140109

Trial on Three Eating Disorders Group Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Eating Disorders Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Association Endat

Paris, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm 1: Cognitive-dissonance based program

Other

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

Arm 2: Mindfulness-based program

Other

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

Arm 3: Person-centered program

Other

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

Primary outcomes

  1. Mean change in The Eating Disorders Diagnostic Interview from pretest to 1-year follow-up

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Mean change in the subscale "Body dissatisfaction" from the scale Eating disorders inventory-2 from pretest to 1-year follow-up

    Time frame: 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.

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

    Time frame: 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.

  4. Mean change in the World Health Organization Quality Of Life Scale from pretest to 1-year follow-up

    Time frame: 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.

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

    Time frame: 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.

  6. Mean change in the Equanimity scale from pretest to 1-year follow-up

    Time frame: 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.

Other outcomes

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

    Time frame: At 3-months follow-up and 1-year follow-up

    A YES/NO answer

  2. Demographic data (age) at pretest

    Time frame: At pretest

    Current age of the participant

  3. Demographic data (socio-professional status) at pretest

    Time frame: At pretest

    Current job of the participant

  4. Demographic data (marital status) at pretest

    Time frame: At pretest

    Current marital status of the participnat

  5. Demographic data (education level) at pretest

    Time frame: At pretest

    Educational degree of the participant

  6. Demographic data (Body Mass Index) at pretest

    Time frame: At pretest

    Current height and weight of the participant

  7. Demographic data (duration of eating disorders symptoms) at pretest

    Time frame: At pretest

    Number of years since the first symptoms of eating disorders

  8. Demographic data (treatment medical history for eating disorders symptoms) at pretest

    Time frame: At pretest

    Names of treatment done in the past

  9. Demographic data (traumatic medical history) at pretest

    Time frame: At pretest

    A YES/NO questionnaires on potential traumatic events

Sponsors and collaborators

Lead sponsor

Université Lumière Lyon 2

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Dec 1, 2021
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.