NCT05362981

Contra-attitudinal Versus Mindfulness Treatment in Anorexia Nervosa Controlled Trial

Contra-attitudinal Versus Mindfulness Treatment in Anorexia Nervosa - Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study propose to compare the effectiveness of two care programs, the CAT and cognitive therapy based on mindfulness (Mindfulness-Based Cognitive Therapy, MBCT) compared to the usual care ("Treated as usual", TAU) in AM and to show their benefit on dimensions specific to EDs such as body dissatisfaction and the internalization of the ideal of thinness, but also on eating symptoms and the anxious and depressive dimensions.

Detailed description

The patients will be recruited from the active files of the four centers participating in the study. In order to avoid the disappointment bias, they will be randomized into three groups, according to a procedure adapted from the Zelen method, in two stages. After verification of the inclusion criteria, eligible patients will receive initial information detailing the follow-up methods, but not the intervention. If patients agree to participate, they will be randomized to three groups: CAT, MBCT or usual management. Patients in the CAT and MBCT groups will then be informed of the group in which they have been randomized, will sign a new consent form and the corresponding intervention will be offered to them. Experimental group: 2 group programs, led by trained facilitators, addressing specific ED topics through written, verbal and/or behavioral exercises, * by following a directive standardized manual aimed at inducing cognitive dissonance (CAT group) * via a specific TCA mindfulness approach (MBCT group) Control group: usual management (TAU). Same number of sessions as the experimental group (8 weekly sessions), consisting of supportive psychotherapy, +/- adjunctive drug treatment, symptomatic. HibernAM ancillary study: For patients with restrictive anorexia nervosa, serum collection on inclusion. Collection of serum from blood samples taken as part of routine care for matched healthy subjects. Addition of serum from patients with restrictive anorexia nervosa, and from matched healthy subjects, to human myotubes in culture for the exploration of protein metabolism

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
OTHER	CAT	2 group programs, led by trained speakers, addressing specific ED topics through written, verbal and/or behavioral exercises,

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-05-01
• Completion: 2024-06-01
• First posted: 2022-05-05
• Last updated: 2023-06-09

Locations

1 site across 1 country: France