Contra-attitudinal Versus Mindfulness Treatment in Anorexia Nervosa Controlled Trial (CAT-AN)

June 8, 2023 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • Julien Colombat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Anorexia nervosa as defined by the DSM-5 (anorexia nervosa of pure restrictive type F50.01 or purgative type F50.02),
  • 14 < BMI < 18.5 (outpatient management possible)
  • Affiliation to a social security scheme or beneficiary of such a scheme
  • Signed informed consent

Exclusion Criteria:

  • other group support of their TCA
  • regular psychological follow-up for a main psychiatric disorder other than TCA
  • mental retardation or psychiatric pathology other than TCA or severe somatic not allowing efficient participation in the therapeutic program and interviews
  • presence, at the time of the study, of a chronic condition that typically affects weight (digestive disease such as celiac disease, Crohn's disease; malignant tumor pathology; endocrine pathology such as hypo/hyperthyroidism, hyper/ hypocortisolism, pituitary or hypothalamic tumor, etc.).
  • refusal to participate in the study
  • pregnant, lactating women
  • period of exclusion from another study,
  • administrative or judicial supervision
  • subject cannot be contacted in case of emergency

Ancillary study: Volunteers will be excluded from the control group:

  • having a significant biological abnormality
  • a history of TCA or pathology likely to impact protein metabolism,
  • pregnancy or breastfeeding at the time of the blood sample,
  • under guardianship, deprivation of liberty, administrative or judicial supervision and exclusion from another study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAT
induction of cognitive dissonance
Other: CAT
2 group programs, led by trained speakers, addressing specific ED topics through written, verbal and/or behavioral exercises,
Other Names:
  • MBCT
Experimental: MBCT
TCA-specific mindfulness approach
Other: CAT
2 group programs, led by trained speakers, addressing specific ED topics through written, verbal and/or behavioral exercises,
Other Names:
  • MBCT
No Intervention: TAU
usual support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of the Body Shape Questionnaire BSQ-34 self-administered questionnaires at 3 months, adjusted to the initial score (D0).
Time Frame: 3 months

The main objective is to compare the effectiveness of CAT and MBCT programs compared to the usual care, on the reduction of body dissatisfaction, in patients presenting with AM. If one or both of these methods are superior to the usual support, we will compare them with each other following a hierarchical sequential analysis method.

months, adjusted to the initial score (D0).

The attitudinal dimension of body image can be assessed using the "Body Shape Questionnaire" (BSQ)-34, a one-dimensional self-questionnaire composed of 34 items assessing body dissatisfaction. (BSQ; Cooper, Taylor, Cooper, & Fairburn, 1986). A French version was validated in 2005 [68].

Full BSQ score Classification less than 80= no concern with shape 80 to 110= mild concern with shape 111 to 140= moderate concern with shape over 140= marked concern with shape
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Mircea Polosan, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02346-33

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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