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

NCT05227625 | Unknown

• 1 other identifier: RECHMPL21_0279
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eating Disorders

Keywords

eating disorders; anorexia; bulimia; body dissatisfaction

Outcome Measures

Primary Outcomes (1)

• 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

  immediate post intervention

Secondary Outcomes (23)

• Body dissatisfaction

  1 month post intervention

• Body dissatisfaction

  3 months post intervention

• eating behavior

  immediate post intervention

• eating behavior

  1 month post intervention

• eating behavior

  3 months post intervention

Study Arms (2)

Body dissatisfaction management group

EXPERIMENTAL

ACT-inspired group for the management of body dissatisfaction

Behavioral: body dissatisfaction management group

relaxation group

ACTIVE COMPARATOR

standardized relaxation program

Behavioral: Relaxation Group

Interventions

body dissatisfaction management group 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.

Body dissatisfaction management group

Relaxation Group 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.

relaxation group

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia; Bulimia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperphagia

Central Study Contacts

Kathyne DUPUIS MAURIN

CONTACT

+33467335663; k-dupuis@chu-montpellier.fr

maude SENEQUE

CONTACT

+33467335663; m-senequehaize@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 7, 2022

Record last verified: 2022-01