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Clinical Trials/NCT05140109
NCT05140109
Completed
Not Applicable

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

Université Lumière Lyon 21 site in 1 country100 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eating Disorders
Sponsor
Université Lumière Lyon 2
Enrollment
100
Locations
1
Primary Endpoint
Mean change in The Eating Disorders Diagnostic Interview from pretest to 1-year follow-up
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
September 22, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Université Lumière Lyon 2
Responsible Party
Principal Investigator
Principal Investigator

TURGON Roxane

Principal investigator

Université Lumière Lyon 2

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

Outcomes

Primary Outcomes

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

  • 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 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)
  • Mean change in the Equanimity scale 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 Hospital Anxiety and Depression Scale from pretest to 1-year follow-up(From pretest to 1-year follow-up)

Study Sites (1)

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