Contra-attitudinal Versus Mindfulness Treatment in Anorexia Nervosa Controlled Trial (CAT-AN)
Primary Purpose
Anorexia Nervosa
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CAT
Sponsored by
About this trial
This is an interventional other trial for Anorexia Nervosa
Eligibility Criteria
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.
Sites / Locations
- Julien Colombat
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
CAT
MBCT
TAU
Arm Description
induction of cognitive dissonance
TCA-specific mindfulness approach
usual support
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05362981
First Posted
May 2, 2022
Last Updated
June 8, 2023
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT05362981
Brief Title
Contra-attitudinal Versus Mindfulness Treatment in Anorexia Nervosa Controlled Trial
Acronym
CAT-AN
Official Title
Contra-attitudinal Versus Mindfulness Treatment in Anorexia Nervosa - Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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.
Masking
None (Open Label)
Masking 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.
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAT
Arm Type
Experimental
Arm Description
induction of cognitive dissonance
Arm Title
MBCT
Arm Type
Experimental
Arm Description
TCA-specific mindfulness approach
Arm Title
TAU
Arm Type
No Intervention
Arm Description
usual support
Intervention Type
Other
Intervention Name(s)
CAT
Other Intervention Name(s)
MBCT
Intervention Description
2 group programs, led by trained speakers, addressing specific ED topics through written, verbal and/or behavioral exercises,
Primary Outcome Measure Information:
Title
Score of the Body Shape Questionnaire BSQ-34 self-administered questionnaires at 3 months, adjusted to the initial score (D0).
Description
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
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mircea Polosan
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Julien Colombat
City
Grenoble
Country
France
12. IPD Sharing Statement
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Contra-attitudinal Versus Mindfulness Treatment in Anorexia Nervosa Controlled Trial
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