Contra-attitudinal Versus Mindfulness Treatment in Anorexia Nervosa Controlled Trial

NCT05362981 | Unknown

• 1 other identifier: 2020-A02346-33
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• Score of the Body Shape Questionnaire BSQ-34 self-administered questionnaires at 3 months, adjusted to the initial score (D0).

  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

Study Arms (3)

CAT

EXPERIMENTAL

induction of cognitive dissonance

Other: CAT

MBCT

EXPERIMENTAL

TCA-specific mindfulness approach

Other: CAT

TAU

NO INTERVENTION

usual support

Interventions

CAT OTHER

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

Also known as: MBCT

CAT; MBCT

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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
• 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,

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Julien Colombat

Grenoble, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Mircea Polosan

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: April 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 9, 2023

Record last verified: 2023-04

Locations

FR (1)