Anorexia NervosaRECOGAMEANCT02400541
Efficacity of Cognitive Remediation Treatment Compared to a Controlled Group in Young Patient With Anorexia Nervosa
A study testing Cognitive remediation therapy and relaxation therapy in people with Anorexia Nervosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Cognitive remediation therapy and relaxation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to 22 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Neuropsychological and Clinical Impact of Cognitive Remediation Program Among Children and Adolescents Treated for Anorexia Nervosa
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.
Read the detailed description
In this research, the investigators want to evaluate remediation cognitive therapy in anorexia nervosa compared to a controlled group (relaxation) based on different factors that testified the cognitive improvement of patients: one week after therapy, six months after and one year after.
Those factors are:
Weight, perfectionism and food symptomatology, temperament, therapeutic alliance and change motivation, clinical evolution of anorexia nervosa, self esteem, executive functions, neuropsychological performance (flexibility and central coherence).
- Conditions
- Anorexia Nervosa
- Being tested
- Cognitive remediation therapy, relaxation therapy
- Keywords
- Anorexia nervosa, Cognitive remediation therapy
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediation therapyBehavioural
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.
relaxation therapyOther
Our scheme comprises 10 biweekly sessions. Each session last about 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive remediation therapy | Experimental | 10 sessions of the cognitive remediation therapy program conducted during five weeks Receives: Behavioral: Cognitive remediation therapy |
| relaxation therapy | Placebo comparator | 10 relaxation sessions during 5 weeks Receives: Other: relaxation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months after therapy
Secondary outcomes (7)
Weight status
Assess the impact of cognitive remediation therapy on :Weight status by the Body Mass Index
Measured: 6 months and one year
Food symptoms and perfectionism
Assess the impact of cognitive remediation therapy on :Food symptoms and perfectionism measured by the Eating Disorders Inventory auto questionnaire, EDI-2
Measured: 6 months and one year
Temperamental profile
Assess the impact of cognitive remediation therapy on :Temperamental profile measured by the Junior Temperament and Character Inventory questionnaire
Measured: 6 months after therapy
Therapeutic alliance and motivation to change
Assess the impact of cognitive remediation therapy on : therapeutic alliance and motivation to change measured by self-reported scales Helping Alliance Questionnaire-11 and MOTIV
Measured: 6 months and one year
Self-esteem
measured by the Rosenberg Self-Esteem Scale
Measured: 6 months and one year
Executive functions
measured by the scale BRIEF-Parent Report
Measured: 6 months and one year
Neuropsychological performance in particular flexibility and central coherence
measured by tests of WCST (Wisconsin Card Sorting Test), Geft (Group Embedded Figure Test) and tests the battery Ravello Profile (Tower, Verbal Fluency Test VFT, Trail Making Test TMT, Rey Complex Figure Test Osterreich ROCFT )
Measured: 6 months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion22 Dec 2019
- Study completion22 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asch Muriel, PHD, Principal investigator, -Hôpital Robert Debré, Service de psychiatrie de l'enfant et de l'adolescent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400541
- Sponsor's protocol ID
- P130905
- Acronym
- RECOGAMEA
- Status last verified
- Apr 2020
- First submitted
- 27 Jan 2015
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Neuropsychological and Clinical Impact of Cognitive Remediation Program Among Children and Adolescents Treated for Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02400541
- Acronym / sponsor ID
- RECOGAMEA / P130905
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Cognitive remediation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 22 Dec 2019 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this research, the investigators want to evaluate remediation cognitive therapy in anorexia nervosa compared to a controlled group (relaxation) based on different factors that testified the cognitive improvement of patients: one week after therapy, six months after and one year after.
Those factors are:
Weight, perfectionism and food symptomatology, temperament, therapeutic alliance and change motivation, clinical evolution of anorexia nervosa, self esteem, executive functions, neuropsychological performance (flexibility and central coherence).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive remediation therapy | Experimental | Behavioral: Cognitive remediation therapy10 sessions of the cognitive remediation therapy program conducted during five weeks |
| relaxation therapy | Placebo comparator | Other: relaxation therapy10 relaxation sessions during 5 weeks |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Pathology
- Topics
- Treatments
Key exclusion criteria (10 listed)
- Pathology
- Topics The subjects are not mastering the French language will not be considered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive remediation therapyOur 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. | Behavioural | Cognitive remediation therapy |
| relaxation therapyOur scheme comprises 10 biweekly sessions. Each session last about 45 minutes. | Other | relaxation therapy |
Primary outcome
cognitive flexibility
Time frame: 6 months after therapy
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).
7 secondary outcomes
Weight status
Time frame: 6 months and one year
Food symptoms and perfectionism
Time frame: 6 months and one year
Temperamental profile
Time frame: 6 months after therapy
Therapeutic alliance and motivation to change
Time frame: 6 months and one year
Self-esteem
Time frame: 6 months and one year
Executive functions
Time frame: 6 months and one year
Neuropsychological performance in particular flexibility and central coherence
Time frame: 6 months and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asch Muriel, PHD principal investigator
-Hôpital Robert Debré, Service de psychiatrie de l'enfant et de l'adolescent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation therapy and relaxation therapy in people with Anorexia Nervosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive flexibility (time frame: 6 months after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.