Trial on Three Eating Disorders Group Treatment

Sponsor
University Grenoble Alps (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05140109
Collaborator
(none)
100
1
3
48.7
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Arm 1: Cognitive-dissonance based program
  • Other: Arm 2: Mindfulness-based program
  • Other: Arm 3: Person-centered program
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness Randomized Controlled Trial on Eating Disorders Group Treatment: a Cognitive Dissonance, a Mindfulness and a Person-centered Based Program
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Jan 29, 2021
Anticipated Study Completion Date :
Sep 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cognitive-dissonance based program

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

Other: Arm 1: Cognitive-dissonance based program
The first four sessions focus on body image and the last four sessions on eating behavior.

Active Comparator: Mindfulness-based program

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

Other: Arm 2: Mindfulness-based program
The sessions focus on different contents as body image, eating behavior and emotion regulation.

Active Comparator: Person-centered program

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

Other: Arm 3: Person-centered program
The sessions are not structured. Participants can bring any subject they need to talk.

Outcome Measures

Primary Outcome Measures

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

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

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

  2. Demographic data (age) at pretest [At pretest]

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

  4. Demographic data (marital status) at pretest [At pretest]

  5. Demographic data (education level) at pretest [At pretest]

  6. Demographic data (Body Mass Index) at pretest [At pretest]

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

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

  9. Demographic data (traumatic medical history) at pretest [At pretest]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Association Endat Paris France 75015

Sponsors and Collaborators

  • University Grenoble Alps

Investigators

  • Principal Investigator: Roxane Turgon, Université Grenoble-Alpes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roxane Turgon, Principal investigator, University Grenoble Alps
ClinicalTrials.gov Identifier:
NCT05140109
Other Study ID Numbers:
  • 2020-A02346-33a
First Posted:
Dec 1, 2021
Last Update Posted:
Dec 1, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2021