NCT02400541

Brief Summary

The aim of research is to test in a randomized clinical trial with active sessions, the efficacy of cognitive remediation therapy in children anorexia nervosa compared to a controlled group. The investigators want to confirm the efficacy of cognitive remediation treatment in children's flexibility problems.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2019

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

4.8 years

First QC Date

January 27, 2015

Last Update Submit

April 28, 2020

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosaCognitive remediation therapy

Outcome Measures

Primary Outcomes (1)

  • cognitive flexibility

    behavioral characteristics related to cognitive difficulties flexibility of anorexic patients, as measured in the medium term (6 months post treatment) by the score of the subscale "shift" BRIEF parent version of the scale (BRIEF-PR).

    6 months after therapy

Secondary Outcomes (7)

  • Weight status

    6 months and one year

  • Food symptoms and perfectionism

    6 months and one year

  • Temperamental profile

    6 months after therapy

  • Therapeutic alliance and motivation to change

    6 months and one year

  • Self-esteem

    6 months and one year

  • +2 more secondary outcomes

Study Arms (2)

Cognitive remediation therapy

EXPERIMENTAL

10 sessions of the cognitive remediation therapy program conducted during five weeks

Behavioral: Cognitive remediation therapy

relaxation therapy

PLACEBO COMPARATOR

10 relaxation sessions during 5 weeks

Other: relaxation therapy

Interventions

Cognitive remediation therapyBEHAVIORAL

Our scheme comprises 10 biweekly sessions ( 5 in group and 5 single) . Each session last about 45 minutes. Individual sessions will be held with the patient and a therapist trained in the CRT; group sessions will be led by two therapists trained in CRT and regroup the maximum 5 patients.

Cognitive remediation therapy
relaxation therapyOTHER

Our scheme comprises 10 biweekly sessions. Each session last about 45 minutes.

relaxation therapy

Eligibility Criteria

Age8 Years - 16 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pathology
  • DSM IV criteria of restrictive anorexia nervosa (AN- R), but not requiring amenorrhea or DSM V
  • Accepting and their parents to participate in the study ( signed consents )
  • Topics
  • Female supported for AN- R
  • Aged 8 to 16 years
  • Fluent French
  • Inpatients or outpatients suffering of restrictive anorexia nervosa
  • Treatments
  • Supports standard load ( family psychotherapy , dietary management , medical monitoring )
  • In case of anxiety or depression , patients may receive additional psychotropic prescription which should be mentioned in the record
  • Treatments previously followed by patients and treatments for other conditions should be described

You may not qualify if:

  • Pathology
  • Mental Retardation
  • Schizophrenia
  • Organic brain disorder ( encephalitis , degenerative brain tumor , cerebral neuro- degenerative disease , multiple sclerosis , amyotrophic lateral sclerosis, epilepsy )
  • Metabolic Pathology interfere with feeding or its regulation
  • Trouble consumption current substance
  • Severe somatic pathology , progressive or likely to be life -threatening
  • Topics The subjects are not mastering the French language will not be considered
  • Subjects or parents do not have sufficient capacity for understanding instructions and consent
  • No affiliation in social security ( beneficiary or legal )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asch

Paris, 75019, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Asch Muriel, PHD

    -Hôpital Robert Debré, Service de psychiatrie de l'enfant et de l'adolescent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2015

First Posted

March 27, 2015

Study Start

March 1, 2015

Primary Completion

December 22, 2019

Study Completion

December 22, 2019

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations

FR(1)