TeenagerTreCogAMNCT01772394
Cognitive Remediation Therapy in Anorexia Nervosa
A study testing Cognitive Remediation Therapy in people with Teenager and Young Adult, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
"Clinicians from the Maudsley (IoP, London, UK) have specifically tailored a cognitive remediation therapy (CRT) for treating Anorexia Nervosa (AN). It is an intensive manualised training cognitive therapy which addresses the difficulties in flexibility and holistic processing that have been incriminated in AN. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Teenager, Young Adult, Hospitalized
- What is being tested?
- Cognitive Remediation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2012to Jan 2017
- 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 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- female;
- 15-40 years old;
- hospitalised for a diagnosis of Anorexia Nervosa (DSM-IV Revised criteria) in one of the three departments participating in this research ;
- fluent in French;
- who provide their informed consent (or as far as possible their parents for those under 18).
Who cannot join
- previous history of neurological disorders;
- actual substance use disorder;
- schizophrenia;
- presenting a related somatic illness (diabetes, Crohn's disease, metabolic illness) or a life-threatening condition.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Clinique Villa Montsouris
Paris, 75013
Institut Mutualiste Monsouris
Paris, 75014
Maison de Solenn
Paris, 75014
Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse
Villejuif, 94804
About this study
Official title: Cognitive Remediation Therapy Effectiveness in Anorexia Nervosa: a Multicenter Randomized Clinical Study
"Clinicians from the Maudsley (IoP, London, UK) have specifically tailored a cognitive remediation therapy (CRT) for treating Anorexia Nervosa (AN). It is an intensive manualised training cognitive therapy which addresses the difficulties in flexibility and holistic processing that have been incriminated in AN. CRT has been found to improve AN's neuropsychological functioning and short term outcome. To our knowledge, no French speaking country has tested its effectiveness. Moreover, the question whether it is efficient for both anorexic restrictive and anorexic binge-purging patients remains unanswered.
The aim of the present study is to determine if CRT in AN adolescents and young adults has a favourable impact on cognitive functioning and clinical status. We will also explore whether the impact of CRT is similar in both anorexic restrictive and binge-purging subtypes. There will also be an Historical Control Group of patients, sixty, who received traditional medical interventions in a specialized inpatient unit for eating disorders (i.e., EVHAN study)."
Read the detailed description
"Several studies have documented that patients with Anorexia Nervosa (AN) display a trait of cognitive inflexibility (e;g., poor set-shifting performances on the Trail Making Task B), i.e. an inability to move flexibly back and forth between tasks, operations, or mental sets which allows for the adaptation of behaviour in response to changing demands within the environment. This cognitive inflexibility can be observed both during the acute phase of the illness and after weight restoration, and has been found to predict negative treatment outcomes. 'Weak central coherence' is another skill which is particularly problematic in AN. It refers to a cognitive style in which information remains fragmented as opposed to integrated, with processing occurring at the level of 'detail' as opposed to 'whole'. AN patients exhibit this detail focussed information-processing style (e.g., as measured by the Embedded Figures Test). To treat these difficulties, clinicians from the Institute of Psychiatry (London, UK) have specifically tailored a treatment for AN. Cognitive remediation therapy (CRT) is an intensive training cognitive therapy that encourages people to reflect on and try to modify the way they think, with a particular focus on improving cognitive flexibility. It is a manualised therapist-led intervention consisting of multiple versions of a variety of tasks and mental exercises that address the difficulties in flexibility and holistic processing. CRT is a 10-sessions long program that has been found to improve AN's neuropsychological functioning and short term outcome. To our knowledge, no French speaking country has tested its effectiveness. Moreover, the question whether it is efficient for both anorexic restrictive and anorexic binge-purging patients remains unanswered.
To address these issues, we designed a multicenter randomized clinical trial on the effectiveness of CRT in AN adolescents and young adults.
Main hypothesis: AN patients treated with CRT present a better clinical status than those treated by a control therapy.
Recruitment and Procedure: 120 female adolescents or young adults [15-40 years old] AN (60 Anorexic Restrictive; 60 Anorexic Binge-Purging) will be recruited among the patients of specialized ED care units of three hospitals: PAUL BROUSSE, INSTITUT MUTUALISTE MONTSOURIS, COCHIN-MAISON DE SOLENN. In each group of AN subtype, the patients will be randomly allocated to one of the two treatment arms: CRT or Sham Therapy (ST). Each therapy is manualised and includes 10 sessions over a period of 5 weeks (2 sessions/week). All the patients will be assessed just prior the beginning and after the end of the CRT/ST, at 6 months and 1 year of follow-up."
- Being tested
- Cognitive Remediation Therapy, Sham Therapy
- Keywords
- Anorexia Nervosa, Cognitive remediation therapy, Randomized clinical trial
- 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
Also called CRT
Cognitive remediation therapy (CRT) is an intensive training cognitive therapy that encourages people to reflect on and try to modify the way they think, with a particular focus on improving cognitive flexibility. It is a manualised therapist-led intervention consisting of multiple versions of a variety of tasks and mental exercises that address the difficulties in flexibility and holistic processing. CRT is an individual 10-sessions long program (2 sessions per week).
Sham TherapyBehavioural
Also called ST
The Sham therapy (ST) has been designed to match the CRT format: an individual manualised therapist-led 10-sessions long program (2 sessions per week). ST sessions have been designed so as to avoid set-shifting and central coherence training. Rather, ST is a manualised sham intervention consisting of multiple exercises on 3 domains: soft physical activity, emotional expression recognition and interpersonal functioning.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation Therapy (CRT) | Active comparator | Active : CRT Receives: Behavioral: Cognitive Remediation Therapy |
| Sham Therapy (ST) | Sham comparator | Sham : ST Receives: Behavioral: Sham Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological functioning:Wisconsin Sorting Card Test (WSCT)
The WSCT are two neuropsychological tests that have been consistently used to highlight poor set-shifting skills in Anorexia nervosa.
Measured: 1 week post-therapy
Clinical status Evaluation:Morgan and Russell Global Outcome Assessment Scale (GOAS);
The Global Outcome Assessment Schedule (GOAS; Morgan \& Hayward, 1998) is a standard measure of outcome in eating disorders; it includes 14 subscales evaluating five dimensions: (A) Food Intake and body weight ; (B) Menstrual status; (C) Mental state ; (D) Psychosexual state ; (E) Socioeconomic status and social functioning.
Measured: up to 1 year of follow-up
Secondary outcomes (15)
Central coherence
Central coherence: Rey figure;
Measured: 1 week post-therapy
Nutritional status
body mass index
Measured: 1 week post-therapy
Nutritional status
body mass index
Measured: 6 months of follow-up
Nutritional status
body mass index
Measured: 1 year of follow-up
Self-reported eating disorders symptoms
Eating Disorder Examination Questionnaire and Body Shape Questionnaire
Measured: 1 week post-therapy
Self-reported eating disorders symptoms
Eating Disorder Examination Questionnaire and Body Shape Questionnaire
Measured: 1 year of follow-up
Self-reported Cognitive style;
Detail and Flexibility Questionnaire
Measured: 1 week post-therapy
Self-reported Cognitive style;
Detail and Flexibility Questionnaire
Measured: 1 year of follow-up
Self-reported treatment satisfaction
Helping Alliance Questionnaire and Patient Satisfaction Questionnaire
Measured: 1 week post-therapy
Self-reported motivation to change
the Maudsley motivation to change questionnaire
Measured: 1 week post-therapy
Self-reported motivation to change
the Maudsley motivation to change questionnaire
Measured: 6 months of follow-up
Self-reported motivation to change
the Maudsley motivation to change questionnaire
Measured: 1 year of follow-up
Self-reported self-esteem
Rosenberg self-esteem Questionnaire
Measured: 1 week post-therapy
Self-reported self-esteem
Rosenberg self-esteem Questionnaire
Measured: 1 year of follow-up
Flexibility evolution : Trail Making Test (TMT)
Neuropsychological functioning
Measured: 1 week post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TeenagerStudies 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
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie BERTHOZ, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, FranceDamien RINGUENET, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772394
- Sponsor's protocol ID
- RCB-2011-A01280-41
- Other IDs
- P091123
- Acronym
- TreCogAM
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2013
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maria AS, Barry C, Ringuenet D, Falissard B, Group T, Berthoz S. Subjective cognitive rigidity and attention to detail: A cross-cultural validation of the Detail and Flexibility Questionnaire (DFlex) in a French clinical sample. J Clin Exp Neuropsychol. 2020 Dec;42(10):1059-1071. doi: 10.1080/13803395.2020.1842333. Epub 2020 Dec 4.
PubMed 33274668Maria AS, Bourdier L, Duclos J, Ringuenet D, Berthoz S. Psychometric properties of the French version of a scale measuring perceived emotional intelligence : the Trait Meta-Mood Scale (TMMS). Can J Psychiatry. 2016 Oct;61(10):652-62. doi: 10.1177/0706743716639936. Epub 2016 Mar 28.
PubMed 27310229
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation Therapy Effectiveness in Anorexia Nervosa: a Multicenter Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT01772394
- Acronym / sponsor ID
- TreCogAM / RCB-2011-A01280-41
- Keywords
- Anorexia Nervosa, Cognitive remediation therapy, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Jan 2013 (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.
"Clinicians from the Maudsley (IoP, London, UK) have specifically tailored a cognitive remediation therapy (CRT) for treating Anorexia Nervosa (AN). It is an intensive manualised training cognitive therapy which addresses the difficulties in flexibility and holistic processing that have been incriminated in AN. CRT has been found to improve AN's neuropsychological functioning and short term outcome. To our knowledge, no French speaking country has tested its effectiveness. Moreover, the question whether it is efficient for both anorexic restrictive and anorexic binge-purging patients remains unanswered.
The aim of the present study is to determine if CRT in AN adolescents and young adults has a favourable impact on cognitive functioning and clinical status. We will also explore whether the impact of CRT is similar in both anorexic restrictive and binge-purging subtypes. There will also be an Historical Control Group of patients, sixty, who received traditional medical interventions in a specialized inpatient unit for eating disorders (i.e., EVHAN study)."
Detailed description
"Several studies have documented that patients with Anorexia Nervosa (AN) display a trait of cognitive inflexibility (e;g., poor set-shifting performances on the Trail Making Task B), i.e. an inability to move flexibly back and forth between tasks, operations, or mental sets which allows for the adaptation of behaviour in response to changing demands within the environment. This cognitive inflexibility can be observed both during the acute phase of the illness and after weight restoration, and has been found to predict negative treatment outcomes. 'Weak central coherence' is another skill which is particularly problematic in AN. It refers to a cognitive style in which information remains fragmented as opposed to integrated, with processing occurring at the level of 'detail' as opposed to 'whole'. AN patients exhibit this detail focussed information-processing style (e.g., as measured by the Embedded Figures Test). To treat these difficulties, clinicians from the Institute of Psychiatry (London, UK) have specifically tailored a treatment for AN. Cognitive remediation therapy (CRT) is an intensive training cognitive therapy that encourages people to reflect on and try to modify the way they think, with a particular focus on improving cognitive flexibility. It is a manualised therapist-led intervention consisting of multiple versions of a variety of tasks and mental exercises that address the difficulties in flexibility and holistic processing. CRT is a 10-sessions long program that has been found to improve AN's neuropsychological functioning and short term outcome. To our knowledge, no French speaking country has tested its effectiveness. Moreover, the question whether it is efficient for both anorexic restrictive and anorexic binge-purging patients remains unanswered.
To address these issues, we designed a multicenter randomized clinical trial on the effectiveness of CRT in AN adolescents and young adults.
Main hypothesis: AN patients treated with CRT present a better clinical status than those treated by a control therapy.
Recruitment and Procedure: 120 female adolescents or young adults [15-40 years old] AN (60 Anorexic Restrictive; 60 Anorexic Binge-Purging) will be recruited among the patients of specialized ED care units of three hospitals: PAUL BROUSSE, INSTITUT MUTUALISTE MONTSOURIS, COCHIN-MAISON DE SOLENN. In each group of AN subtype, the patients will be randomly allocated to one of the two treatment arms: CRT or Sham Therapy (ST). Each therapy is manualised and includes 10 sessions over a period of 5 weeks (2 sessions/week). All the patients will be assessed just prior the beginning and after the end of the CRT/ST, at 6 months and 1 year of follow-up."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation Therapy (CRT) | Active comparator | Behavioral: Cognitive Remediation TherapyActive : CRT |
| Sham Therapy (ST) | Sham comparator | Behavioral: Sham TherapySham : ST |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- female;
- 15-40 years old;
- hospitalised for a diagnosis of Anorexia Nervosa (DSM-IV Revised criteria) in one of the three departments participating in this research ;
- fluent in French;
- who provide their informed consent (or as far as possible their parents for those under 18).
Key exclusion criteria (4 listed)
- previous history of neurological disorders;
- actual substance use disorder;
- schizophrenia;
- presenting a related somatic illness (diabetes, Crohn's disease, metabolic illness) or a life-threatening condition.
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 TherapyAlso: CRTCognitive remediation therapy (CRT) is an intensive training cognitive therapy that encourages people to reflect on and try to modify the way they think, with a particular focus on improving cognitive flexibility. It is a manualised therapist-led intervention consisting of multiple versions of a variety of tasks and mental exercises that address the difficulties in flexibility and holistic processing. CRT is an individual 10-sessions long program (2 sessions per week). | Behavioural | Cognitive Remediation Therapy (CRT) |
| Sham TherapyAlso: STThe Sham therapy (ST) has been designed to match the CRT format: an individual manualised therapist-led 10-sessions long program (2 sessions per week). ST sessions have been designed so as to avoid set-shifting and central coherence training. Rather, ST is a manualised sham intervention consisting of multiple exercises on 3 domains: soft physical activity, emotional expression recognition and interpersonal functioning. | Behavioural | Sham Therapy (ST) |
Primary outcome
Neuropsychological functioning:Wisconsin Sorting Card Test (WSCT)
Time frame: 1 week post-therapy
The WSCT are two neuropsychological tests that have been consistently used to highlight poor set-shifting skills in Anorexia nervosa.
Clinical status Evaluation:Morgan and Russell Global Outcome Assessment Scale (GOAS);
Time frame: up to 1 year of follow-up
The Global Outcome Assessment Schedule (GOAS; Morgan \& Hayward, 1998) is a standard measure of outcome in eating disorders; it includes 14 subscales evaluating five dimensions: (A) Food Intake and body weight ; (B) Menstrual status; (C) Mental state ; (D) Psychosexual state ; (E) Socioeconomic status and social functioning.
15 secondary outcomes
Central coherence
Time frame: 1 week post-therapy
Nutritional status
Time frame: 1 week post-therapy
Nutritional status
Time frame: 6 months of follow-up
Nutritional status
Time frame: 1 year of follow-up
Self-reported eating disorders symptoms
Time frame: 1 week post-therapy
Self-reported eating disorders symptoms
Time frame: 1 year of follow-up
Self-reported Cognitive style;
Time frame: 1 week post-therapy
Self-reported Cognitive style;
Time frame: 1 year of follow-up
Self-reported treatment satisfaction
Time frame: 1 week post-therapy
Self-reported motivation to change
Time frame: 1 week post-therapy
Self-reported motivation to change
Time frame: 6 months of follow-up
Self-reported motivation to change
Time frame: 1 year of follow-up
Self-reported self-esteem
Time frame: 1 week post-therapy
Self-reported self-esteem
Time frame: 1 year of follow-up
Flexibility evolution : Trail Making Test (TMT)
Time frame: 1 week post-therapy
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 16 Jan 2017.
- Derived from this study: PubMed 33274668Maria AS, Barry C, Ringuenet D, Falissard B, Group T, Berthoz S. Subjective cognitive rigidity and attention to detail: A cross-cultural validation of the Detail and Flexibility Questionnaire (DFlex) in a French clinical sample. J Clin Exp Neuropsychol. 2020 Dec;42(10):1059-1071. doi: 10.1080/13803395.2020.1842333. Epub 2020 Dec 4.
- Derived from this study: PubMed 27310229Maria AS, Bourdier L, Duclos J, Ringuenet D, Berthoz S. Psychometric properties of the French version of a scale measuring perceived emotional intelligence : the Trait Meta-Mood Scale (TMMS). Can J Psychiatry. 2016 Oct;61(10):652-62. doi: 10.1177/0706743716639936. Epub 2016 Mar 28.
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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.
Sylvie BERTHOZ, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
Damien RINGUENET, MD principal investigator
Assistance Publique - Hôpitaux de Paris
4 sites 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 in people with Teenager and Young Adult, run by Assistance Publique - Hôpitaux de Paris at 4 sites 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 5 inclusion and 4 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 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Neuropsychological functioning:Wisconsin Sorting Card Test (WSCT) (time frame: 1 week post-therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772394, which also lists 2 linked publications.
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 16 Jan 2017.