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Trial on Three Eating Disorders Group Treatment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05140109
Enrollment
100
Registered
2021-12-01
Start date
2018-09-01
Completion date
2022-09-22
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorders

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.

Interventions

OTHERArm 1: Cognitive-dissonance based program

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

OTHERArm 2: Mindfulness-based program

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

OTHERArm 3: Person-centered program

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

Sponsors

Université Lumière Lyon 2
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Mean change in The Eating Disorders Diagnostic Interview from pretest to 1-year follow-upFrom pretest to 1-year follow-upThe minimum of the scale is 0 and the maximum is 276. A higher score means a worse outcome.

Secondary

MeasureTime frameDescription
Mean change in the subscale Body dissatisfaction from the scale Eating disorders inventory-2 from pretest to 1-year follow-upFrom pretest to 1-year follow-upThe minimum of the scale is 0 and the maximum is 27. A higher score means a worse outcome.
Mean change in the Sociocultural Attitudes Towards Appearance Scale from pretest to 1-year follow-upFrom pretest to 1-year follow-upThe minimum of the scale is 0 and the maximum is 150. A higher score means a worse outcome.
Mean change in The Hospital Anxiety and Depression Scale from pretest to 1-year follow-upFrom pretest to 1-year follow-upThe minimum of the scale is 0 and the maximum is 42. A higher score means a worse outcome.
Mean change in the Strathclyde Inventory measuring congruence from pretest to 1-year follow-upFrom pretest to 1-year follow-upThe minimum of the scale is 0 and the maximum is 4. A higher score means a better outcome.
Mean change in the Equanimity scale from pretest to 1-year follow-upFrom pretest to 1-year follow-upThe minimum of the scale is 0 and the maximum is 7. A higher score means a better outcome.
Mean change in the World Health Organization Quality Of Life Scale from pretest to 1-year follow-upFrom pretest to 1-year follow-upThe minimum of the scale is 0 and the maximum is 20. A higher score means a better outcome.

Other

MeasureTime frameDescription
Demographic data (treatment medical history for eating disorders symptoms) at pretestAt pretestNames of treatment done in the past
Demographic data (marital status) at pretestAt pretestCurrent marital status of the participnat
Demographic data (traumatic medical history) at pretestAt pretestA YES/NO questionnaires on potential traumatic events
Presence or absence of ancillary treatment at 3-months follow-upAt 3-months follow-up and 1-year follow-upA YES/NO answer
Demographic data (age) at pretestAt pretestCurrent age of the participant
Demographic data (socio-professional status) at pretestAt pretestCurrent job of the participant
Demographic data (education level) at pretestAt pretestEducational degree of the participant
Demographic data (Body Mass Index) at pretestAt pretestCurrent height and weight of the participant
Demographic data (duration of eating disorders symptoms) at pretestAt pretestNumber of years since the first symptoms of eating disorders

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026