Eating DisordersNCT05140109
Trial on Three Eating Disorders Group Treatment
A study testing Arm 1: Cognitive-dissonance based program, Arm 2: Mindfulness-based program and Arm 3: Person-centered program in people with Eating Disorders, run by Université Lumière Lyon 2 at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Arm 1: Cognitive-dissonance based program, Arm 2: Mindfulness-based program and Arm 3: Person-centered program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 22 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- a psychotic disorder
- a bipolar disorder
- a mental retardation
- to not read or speak French fluently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness Randomized Controlled Trial on Eating Disorders Group Treatment: a Cognitive Dissonance, a Mindfulness and a Person-centered Based Program
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.
- Conditions
- Eating Disorders
- Being tested
- Arm 1: Cognitive-dissonance based program, Arm 2: Mindfulness-based program, Arm 3: Person-centered program
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: Cognitive-dissonance based programOther
The first four sessions focus on body image and the last four sessions on eating behavior.
Arm 2: Mindfulness-based programOther
The sessions focus on different contents as body image, eating behavior and emotion regulation.
Arm 3: Person-centered programOther
The sessions are not structured. Participants can bring any subject they need to talk.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-dissonance based program | Experimental | Group program of 8 sessions of one hour and a half. Receives: Other: Arm 1: Cognitive-dissonance based program |
| Mindfulness-based program | Active comparator | Group program of 8 sessions of one hour and a half. Receives: Other: Arm 2: Mindfulness-based program |
| Person-centered program | Active comparator | Group program of 8 sessions of one hour and a half. Receives: Other: Arm 3: Person-centered program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in The Eating Disorders Diagnostic Interview 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.
Measured: From pretest to 1-year follow-up
Secondary outcomes (6)
Mean change in The Hospital Anxiety and Depression Scale 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.
Measured: From pretest to 1-year follow-up
Mean change in the subscale "Body dissatisfaction" from the scale Eating disorders inventory-2 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.
Measured: From pretest to 1-year follow-up
Mean change in the Sociocultural Attitudes Towards Appearance Scale 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.
Measured: 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
The minimum of the scale is 0 and the maximum is 20. A higher score means a better outcome.
Measured: From pretest to 1-year follow-up
Mean change in the Strathclyde Inventory measuring congruence 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.
Measured: From pretest to 1-year follow-up
Mean change in the Equanimity scale 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.
Measured: From pretest to 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Sep 2018
- Primary completion29 Jan 2021
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Lumière Lyon 2
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TURGON Roxane, Université Lumière Lyon 2
- Investigators
- Roxane Turgon, Principal investigator, Université Lumière Lyon 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140109
- Sponsor's protocol ID
- 2020-A02346-33a
- Status last verified
- Dec 2024
- First submitted
- 5 Nov 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Randomized Controlled Trial on Eating Disorders Group Treatment: a Cognitive Dissonance, a Mindfulness and a Person-centered Based Program
- ClinicalTrials.gov ID
- NCT05140109
- Acronym / sponsor ID
- 2020-A02346-33a
- Conditions
- Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Université Lumière Lyon 2University, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive-dissonance based program | Experimental | Other: Arm 1: Cognitive-dissonance based programGroup program of 8 sessions of one hour and a half. |
| Mindfulness-based program | Active comparator | Other: Arm 2: Mindfulness-based programGroup program of 8 sessions of one hour and a half. |
| Person-centered program | Active comparator | Other: Arm 3: Person-centered programGroup program of 8 sessions of one hour and a half. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- a psychotic disorder
- a bipolar disorder
- a mental retardation
- to not read or speak French fluently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1: Cognitive-dissonance based programThe first four sessions focus on body image and the last four sessions on eating behavior. | Other | Cognitive-dissonance based program |
| Arm 2: Mindfulness-based programThe sessions focus on different contents as body image, eating behavior and emotion regulation. | Other | Mindfulness-based program |
| Arm 3: Person-centered programThe sessions are not structured. Participants can bring any subject they need to talk. | Other | Person-centered program |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
Mean change in the Strathclyde Inventory measuring congruence from pretest to 1-year follow-up
Time frame: From pretest to 1-year follow-up
Mean change in the Equanimity scale from pretest to 1-year follow-up
Time frame: From pretest to 1-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roxane Turgon principal investigator
Université Lumière Lyon 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: Cognitive-dissonance based program, Arm 2: Mindfulness-based program and Arm 3: Person-centered program in people with Eating Disorders, run by Université Lumière Lyon 2 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in The Eating Disorders Diagnostic Interview from pretest to 1-year follow-up (time frame: From pretest to 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.