Eating DisordersINCCANCT05227625
Randomized Study Assessing a Program of Body Dissatisfaction Psychological Care in Eating Disorders
A study testing body dissatisfaction management group and Relaxation Group in people with Eating Disorders, run by University Hospital, Montpellier.
Trial summary
Eating disorders (ED) are a major public health problem for which current treatments are insufficiently effective. The transdiagnostic approach of eating disorders highlights body dissatisfaction (BD) as a major factor in the development and maintenance of the different types of eating disorders. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Eating Disorders
- What is being tested?
- body dissatisfaction management group and Relaxation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Aug 2024
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ED according to DSM 5 criteria (all types of ED can be included: anorexia, bulimia, binge eating disorder, atypical ED, etc.)
- BMI between 18.5 kg/m2 and 24.9 kg/m2).
- woman over the age of 16
- moderate to severe body dissatisfaction (total BSQ score greater than or equal to 111)
Who cannot join
- current severe psychiatric pathology other than the TCA (severe depression, schizophrenia, etc.) which may alter the ability to follow the group in the opinion of the investigator
- Patient under legal protection measure (guardianship, curatorship, safeguard of justice, authorization family or future protection mandate activated
- Pregnant or breastfeeding women according
- Patient not affiliated to a social security scheme, or beneficiary of such a scheme
- Patient unable to understand the nature, purpose and methodology of the study
- Patient who did not sign the informed consent
- Patient whose legal guardian has not given consent to inclusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Controlled Trial Assessing the Effectiveness of a Psychological Management Program for Body Dissatisfaction in Eating Disorders
Eating disorders (ED) are a major public health problem for which current treatments are insufficiently effective. The transdiagnostic approach of eating disorders highlights body dissatisfaction (BD) as a major factor in the development and maintenance of the different types of eating disorders. Thus, we hypothesize that a group focused on the management of BDc would improve the prognosis of patients with eating disorders.
Read the detailed description
Main and secondary objectives: To evaluate the effectiveness of a BD management group on the level of body dissatisfaction in patients suffering from an ED (BSQ-34 total score immediately after intervention). Secondary: To assess the effectiveness of a BD management group in 1) reducing the desire for thinness, 2) improving quality of life, 3) improving ED symptoms, 4) improvement in depressive symptomatology, 5) increase in cognitive flexibility and acceptance of unpleasant psychological events, 6) improvement in overall functioning.
Methodology : Open randomized controlled trial with two intervention arms (management of BD versus relaxation). Main inclusion criteria: patients over 16 years of age suffering from an ED, presenting moderate to severe BD (BSQ-34≥111) and normal BMI
Main endpoint: evolution of the level of BD (BSQ-34) immediately after the intervention. Secondary judgment criteria: change in the level of BD (BSQ-34) at 1 and 3 months post-intervention \& change in eating symptomatology (EDI, EDE-Q), quality of life (EDQOL), level of depression (MADRS), cognitive flexibility ( AAQ), functioning (WSAS) immediately post-intervention, at 1 and 3 months post-intervention.
Procedure: The participation of each patient includes 4 evaluation visits: inclusion, just after the end of the intervention, at 1 and 3 months after the end of the intervention
Benefits / prospects: We hope that patients who have integrated the interventional group will show a significant improvement in their BD, their functioning and the overall prognosis of the disorder. Positive results would permit to consider a larger multicenter study evaluating the long-term effect of the group on different dimensions of the ED. Finally, it would then be possible to offer standardized care that can be generalized to other centers.
- Conditions
- Eating Disorders
- Being tested
- body dissatisfaction management group, Relaxation Group
- Keywords
- eating disorders, anorexia, bulimia, body dissatisfaction
- Medical subject headings
- Feeding and Eating Disorders, Anorexia, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body dissatisfaction management groupBehavioural
Our group is composed of 10 weekly session of 2 hours led by a psychologist trained in the management of ED and ACT therapy.
Each group will be composed of 5 to 10 people. First of all, the group will lead the participants to better know and understand the impact of BD on the symptomatology of ED by teaching current scientific knowledge on the subject. In a second step, the group will guide the patients in the acquisition of psychological skills to deal with events related to BD and to engage in actions towards the values that give meaning to their existence.
Relaxation GroupBehavioural
Participants will be included in a standardized relaxation program consisting of a weekly 2 hour session for 10 weeks. The group will be led by a psychologist trained in relaxation and in particular in abdominal and muscular relaxation techniques. Each group will be composed of 5 to 10 people. Initially, the therapy will lead the participants to recognize the signs of anxiety and to understand the physiological mechanisms involved. Classic techniques of anxiety management will then be introduced (cardiac coherence, abdominal and muscular relaxation, Jacobson technique, Schultz autogenic training). These techniques will be tested in session. Participants will be encouraged to practice these techniques at home.
| Study group | Role | What they receive |
|---|---|---|
| Body dissatisfaction management group | Experimental | ACT-inspired group for the management of body dissatisfaction Receives: Behavioral: body dissatisfaction management group |
| relaxation group | Active comparator | standardized relaxation program Receives: Behavioral: Relaxation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body dissatisfaction
Assessment of body dissatisfaction using Body shape questionnaire (BSQ-34) 34-item self-administered questionnaire assessing body dissatisfaction across four dimensions: avoidance and social shame of body exposure, body dissatisfaction with lower parts of the body, use of laxatives and vomiting to reduce body dissatisfaction, cognitions and maladaptive behaviors to control weight. The total score ranges from 0 to 204. A score below 80 indicates no excessive body dissatisfaction, a score between 80 and 100 indicates mild body dissatisfaction, between 111 and 140 moderate body dissatisfaction and a score above 140 indicates severe body dissatisfaction
Measured: immediate post intervention
Secondary outcomes (23)
Body dissatisfaction
Assessment of body dissatisfaction using Body shape questionnaire (BSQ-34) 34-item self-administered questionnaire assessing body dissatisfaction across four dimensions: avoidance and social shame of body exposure, body dissatisfaction with lower parts of the body, use of laxatives and vomiting to reduce body dissatisfaction, cognitions and maladaptive behaviors to control weight. The total score ranges from 0 to 204. A score below 80 indicates no excessive body dissatisfaction, a score between 80 and 100 indicates mild body dissatisfaction, between 111 and 140 moderate body dissatisfaction and a score above 140 indicates severe body dissatisfaction
Measured: 1 month post intervention
Body dissatisfaction
Assessment of body dissatisfaction using Body shape questionnaire (BSQ-34) 34-item self-administered questionnaire assessing body dissatisfaction across four dimensions: avoidance and social shame of body exposure, body dissatisfaction with lower parts of the body, use of laxatives and vomiting to reduce body dissatisfaction, cognitions and maladaptive behaviors to control weight. The total score ranges from 0 to 204. A score below 80 indicates no excessive body dissatisfaction, a score between 80 and 100 indicates mild body dissatisfaction, between 111 and 140 moderate body dissatisfaction and a score above 140 indicates severe body dissatisfaction
Measured: 3 months post intervention
eating behavior
Assessment of eating behavior using Eating disorder Inventory (EDI-2). 91-item self-questionnaire aim to evaluate food-related attitudes and behaviors. 11 dimensions emerge : search for thinness, bulimia, dissatisfaction with the body, inefficiency, perfectionism, interpersonal mistrust, interoceptive awareness, fear of maturity, asceticism, impulse control, social insecurity.
A high score reflects a higher intensity of symptoms
Measured: immediate post intervention
eating behavior
Assessment of eating behavior using Eating disorder Inventory (EDI-2). 91-item self-questionnaire aim to evaluate food-related attitudes and behaviors. 11 dimensions emerge : search for thinness, bulimia, dissatisfaction with the body, inefficiency, perfectionism, interpersonal mistrust, interoceptive awareness, fear of maturity, asceticism, impulse control, social insecurity.
A high score reflects a higher intensity of symptoms
Measured: 1 month post intervention
eating behavior
Assessment of eating behavior using Eating disorder Inventory (EDI-2) 91-item self-questionnaire aim to evaluate food-related attitudes and behaviors. 11 dimensions emerge : search for thinness, bulimia, dissatisfaction with the body, inefficiency, perfectionism, interpersonal mistrust, interoceptive awareness, fear of maturity, asceticism, impulse control, social insecurity.
A high score reflects a higher intensity of symptoms
Measured: 3 months post intervention
Quality of life level
Assessment of quality of life using the Eating Disorder Quality Of Life (EDQOL).
EDQOL is a self-questionnaire assessing the quality of life, specific to eating disorders. 4 dimensions are assessed: Psychological, Physical/Cognitive, Financial, Work/School. The scale also produces an overall score. The higher the score, the more the eating disorder impacts the patient's quality of life
Measured: immediate post intervention
Quality of life level
Assessment of quality of life using the Eating Disorder Quality Of Life (EDQOL).
EDQOL is a self-questionnaire assessing the quality of life, specific to eating disorders. 4 dimensions are assessed: Psychological, Physical/Cognitive, Financial, Work/School. The scale also produces an overall score. The higher the score, the more the eating disorder impacts the patient's quality of life
Measured: 1 month post intervention
Quality of life level
Assessment of quality of life using the Eating Disorder Quality Of Life (EDQOL).
EDQOL is a self-questionnaire assessing the quality of life, specific to eating disorders. 4 dimensions are assessed: Psychological, Physical/Cognitive, Financial, Work/School. The scale also produces an overall score. The higher the score, the more the eating disorder impacts the patient's quality of life
Measured: 3 months post intervention
Eating disorder symptomatology
Assessment of Eating disorder symptomatology using the Eating disorder Examination (EDE-q). Self-administered questionnaire assessing the intensity of eating symptoms over the past 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6. The higher the score, the more severe the symptoms.
Measured: immediate post intervention
Eating disorder symptomatology
Assessment of Eating disorder symptomatology using the Eating disorder Examination (EDE-q). Self-administered questionnaire assessing the intensity of eating symptoms over the past 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6. The higher the score, the more severe the symptoms.
Measured: 1 month post intervention
Eating disorder symptomatology
Assessment of Eating disorder symptomatology using the Eating disorder Examination (EDE-q). Self-administered questionnaire assessing the intensity of eating symptoms over the past 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6. The higher the score, the more severe the symptoms.
Measured: 3 months post intervention
depressive symptomatology
Assessment of depressive symptomatology using Montgomery Asberg Depression Scale (MADRS). This hetero-questionnaire assesses the intensity of the patient's depressive symptoms. The total score between 0 and 60 corresponds to the sum of the 10 items. The higher the score, the more severe the symptoms.
Measured: immediate post intervention
depressive symptomatology
Assessment of depressive symptomatology using Montgomery Asberg Depression Scale (MADRS). This hetero-questionnaire assesses the intensity of the patient's depressive symptoms. The total score between 0 and 60 corresponds to the sum of the 10 items. The higher the score, the more severe the symptoms.
Measured: 1 month post intervention
depressive symptomatology
Assessment of depressive symptomatology using Montgomery Asberg Depression Scale (MADRS). This hetero-questionnaire assesses the intensity of the patient's depressive symptoms. The total score between 0 and 60 corresponds to the sum of the 10 items. The higher the score, the more severe the symptoms.
Measured: 3 months post intervention
cognitive flexibility
Assessment of cognitive flexibility using the Acceptance and Action Questionnaire (AAQ).
the AAQ is 7-item self-questionnaire to assess psychological flexibility and psychological acceptance
Measured: immediate post intervention
cognitive flexibility
Assessment of cognitive flexibility using the Acceptance and Action Questionnaire (AAQ).
the AAQ is 7-item self-questionnaire to assess psychological flexibility and psychological acceptance
Measured: 1 month post intervention
cognitive flexibility
Assessment of cognitive flexibility using the Acceptance and Action Questionnaire (AAQ).
the AAQ is 7-item self-questionnaire to assess psychological flexibility and psychological acceptance
Measured: 3 months post intervention
Global functioning
Assessment of Global functioning using the Work and Social Adjustment Scale . The WSAS is self-questionnaire of 5 items aimed at evaluating the consequences of the ED on the overall functioning of the patient. Each item is rated from 0 to 8. The score of the scale therefore varies from 0 (no functioning problem) to 40 (maximum problems). A score greater than 20 suggests a significant impairment in functioning. A score between 10 and 20 suggests moderate impairment. A score of less than 10 suggests no functioning problem
Measured: immediate post intervention
Global functioning
Assessment of Global functioning using the Work and Social Adjustment Scale . The WSAS is self-questionnaire of 5 items aimed at evaluating the consequences of the ED on the overall functioning of the patient. Each item is rated from 0 to 8. The score of the scale therefore varies from 0 (no functioning problem) to 40 (maximum problems). A score greater than 20 suggests a significant impairment in functioning. A score between 10 and 20 suggests moderate impairment. A score of less than 10 suggests no functioning problem
Measured: 1 month post intervention
Global functioning
Assessment of Global functioning using the Work and Social Adjustment Scale . The WSAS is self-questionnaire of 5 items aimed at evaluating the consequences of the ED on the overall functioning of the patient. Each item is rated from 0 to 8. The score of the scale therefore varies from 0 (no functioning problem) to 40 (maximum problems). A score greater than 20 suggests a significant impairment in functioning. A score between 10 and 20 suggests moderate impairment. A score of less than 10 suggests no functioning problem
Measured: 3 months post intervention
mindfulness skills
Assessment of mindfulness skills using Mindful Attention Awarness Scale (MAAS). 15-item self-questionnaire to assess spontaneous mindfulness skills.
Measured: immediate post intervention
mindfulness skills
Assessment of mindfulness skills using Mindful Attention Awarness Scale (MAAS). 15-item self-questionnaire to assess spontaneous mindfulness skills.
Measured: 1 month post intervention
mindfulness skills
Assessment of mindfulness skills using Mindful Attention Awarness Scale (MAAS). 15-item self-questionnaire to assess spontaneous mindfulness skills.
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionAug 2024 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227625
- Sponsor's protocol ID
- RECHMPL21_0279
- Acronym
- INCCA
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Assessing the Effectiveness of a Psychological Management Program for Body Dissatisfaction in Eating Disorders
- ClinicalTrials.gov ID
- NCT05227625
- Acronym / sponsor ID
- INCCA / RECHMPL21_0279
- Conditions
- Eating Disorders
- Keywords
- eating disorders, anorexia, bulimia, body dissatisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 7 Feb 2022 (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.
Eating disorders (ED) are a major public health problem for which current treatments are insufficiently effective. The transdiagnostic approach of eating disorders highlights body dissatisfaction (BD) as a major factor in the development and maintenance of the different types of eating disorders. Thus, we hypothesize that a group focused on the management of BDc would improve the prognosis of patients with eating disorders.
Detailed description
Main and secondary objectives: To evaluate the effectiveness of a BD management group on the level of body dissatisfaction in patients suffering from an ED (BSQ-34 total score immediately after intervention). Secondary: To assess the effectiveness of a BD management group in 1) reducing the desire for thinness, 2) improving quality of life, 3) improving ED symptoms, 4) improvement in depressive symptomatology, 5) increase in cognitive flexibility and acceptance of unpleasant psychological events, 6) improvement in overall functioning.
Methodology : Open randomized controlled trial with two intervention arms (management of BD versus relaxation). Main inclusion criteria: patients over 16 years of age suffering from an ED, presenting moderate to severe BD (BSQ-34≥111) and normal BMI
Main endpoint: evolution of the level of BD (BSQ-34) immediately after the intervention. Secondary judgment criteria: change in the level of BD (BSQ-34) at 1 and 3 months post-intervention \& change in eating symptomatology (EDI, EDE-Q), quality of life (EDQOL), level of depression (MADRS), cognitive flexibility ( AAQ), functioning (WSAS) immediately post-intervention, at 1 and 3 months post-intervention.
Procedure: The participation of each patient includes 4 evaluation visits: inclusion, just after the end of the intervention, at 1 and 3 months after the end of the intervention
Benefits / prospects: We hope that patients who have integrated the interventional group will show a significant improvement in their BD, their functioning and the overall prognosis of the disorder. Positive results would permit to consider a larger multicenter study evaluating the long-term effect of the group on different dimensions of the ED. Finally, it would then be possible to offer standardized care that can be generalized to other centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body dissatisfaction management group | Experimental | Behavioral: body dissatisfaction management groupACT-inspired group for the management of body dissatisfaction |
| relaxation group | Active comparator | Behavioral: Relaxation Groupstandardized relaxation program |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ED according to DSM 5 criteria (all types of ED can be included: anorexia, bulimia, binge eating disorder, atypical ED, etc.)
- BMI between 18.5 kg/m2 and 24.9 kg/m2).
- woman over the age of 16
- moderate to severe body dissatisfaction (total BSQ score greater than or equal to 111)
Key exclusion criteria (7 listed)
- current severe psychiatric pathology other than the TCA (severe depression, schizophrenia, etc.) which may alter the ability to follow the group in the opinion of the investigator
- Patient under legal protection measure (guardianship, curatorship, safeguard of justice, authorization family or future protection mandate activated
- Pregnant or breastfeeding women according
- Patient not affiliated to a social security scheme, or beneficiary of such a scheme
- Patient unable to understand the nature, purpose and methodology of the study
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 |
|---|---|---|
| body dissatisfaction management groupOur group is composed of 10 weekly session of 2 hours led by a psychologist trained in the management of ED and ACT therapy. Each group will be composed of 5 to 10 people. First of all, the group will lead the participants to better know and understand the impact of BD on the symptomatology of ED by teaching current scientific knowledge on the subject. In a second step, the group will guide the patients in the acquisition of psychological skills to deal with events related to BD and to engage in actions towards the values that give meaning to their existence. | Behavioural | Body dissatisfaction management group |
| Relaxation GroupParticipants will be included in a standardized relaxation program consisting of a weekly 2 hour session for 10 weeks. The group will be led by a psychologist trained in relaxation and in particular in abdominal and muscular relaxation techniques. Each group will be composed of 5 to 10 people. Initially, the therapy will lead the participants to recognize the signs of anxiety and to understand the physiological mechanisms involved. Classic techniques of anxiety management will then be introduced (cardiac coherence, abdominal and muscular relaxation, Jacobson technique, Schultz autogenic training). These techniques will be tested in session. Participants will be encouraged to practice these techniques at home. | Behavioural | relaxation group |
Primary outcome
Body dissatisfaction
Time frame: immediate post intervention
Assessment of body dissatisfaction using Body shape questionnaire (BSQ-34) 34-item self-administered questionnaire assessing body dissatisfaction across four dimensions: avoidance and social shame of body exposure, body dissatisfaction with lower parts of the body, use of laxatives and vomiting to reduce body dissatisfaction, cognitions and maladaptive behaviors to control weight. The total score ranges from 0 to 204. A score below 80 indicates no excessive body dissatisfaction, a score between 80 and 100 indicates mild body dissatisfaction, between 111 and 140 moderate body dissatisfaction and a score above 140 indicates severe body dissatisfaction
23 secondary outcomes
Body dissatisfaction
Time frame: 1 month post intervention
Body dissatisfaction
Time frame: 3 months post intervention
eating behavior
Time frame: immediate post intervention
eating behavior
Time frame: 1 month post intervention
eating behavior
Time frame: 3 months post intervention
Quality of life level
Time frame: immediate post intervention
Quality of life level
Time frame: 1 month post intervention
Quality of life level
Time frame: 3 months post intervention
Eating disorder symptomatology
Time frame: immediate post intervention
Eating disorder symptomatology
Time frame: 1 month post intervention
Eating disorder symptomatology
Time frame: 3 months post intervention
depressive symptomatology
Time frame: immediate post intervention
depressive symptomatology
Time frame: 1 month post intervention
depressive symptomatology
Time frame: 3 months post intervention
cognitive flexibility
Time frame: immediate post intervention
cognitive flexibility
Time frame: 1 month post intervention
cognitive flexibility
Time frame: 3 months post intervention
Global functioning
Time frame: immediate post intervention
Global functioning
Time frame: 1 month post intervention
Global functioning
Time frame: 3 months post intervention
mindfulness skills
Time frame: immediate post intervention
mindfulness skills
Time frame: 1 month post intervention
mindfulness skills
Time frame: 3 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing body dissatisfaction management group and Relaxation Group in people with Eating Disorders, run by University Hospital, Montpellier.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathyne DUPUIS MAURIN (+33467335663, k-dupuis@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body dissatisfaction (time frame: immediate post intervention). 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 7 Feb 2022.