Randomized Study Assessing a Program of Body Dissatisfaction Psychological Care in Eating Disorders

NCT ID: NCT05227625

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2024-08-31

Brief 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. 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.

Conditions

Eating Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Body dissatisfaction management group

ACT-inspired group for the management of body dissatisfaction

Group Type: EXPERIMENTAL

body dissatisfaction management group

Intervention Type: BEHAVIORAL

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 group

standardized relaxation program

Group Type: ACTIVE_COMPARATOR

Relaxation Group

Intervention Type: BEHAVIORAL

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.

Interventions

body dissatisfaction management group

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.

Intervention Type: BEHAVIORAL

Relaxation Group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Kathyne DUPUIS MAURIN

Role: CONTACT

k-dupuis@chu-montpellier.fr

+33467335663

maude SENEQUE

Role: CONTACT

m-senequehaize@chu-montpellier.fr

+33467335663

Other Identifiers

RECHMPL21_0279

Identifier Type: -

Identifier Source: org_study_id