Anorexia NervosaNCT05912036
The CORTEX Randomized Control Trial
A study testing CRT in people with Anorexia Nervosa, run by Istituto Auxologico Italiano.
Trial summary
Background: This study aims to evaluate the feasibility and efficacy of a novel Computer-Assisted Cognitive Remediation Therapy (CA-CRT) program as adjunctive treatment to standard care (TAU) in improving cognitive skills in adult inpatients with anorexia nervosa (AN) Methods: A multicenter randomized controlled trial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- CRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria for the participants in the study will be: (1) receiving a diagnosis of AN according to DSM 5 criteria (American Psychiatric Association, 2013) following psychiatric evaluation; (2) being over 18 years; (3) having Italian citizenship; (4) signing the informed consent to participate in the study.
Participants will be excluded from the study if: (1) having specific learning disabilities (SLDs), (2) having intellectual disability, psychosis, previous head injury, history of psychotropic substance use, or other clinical conditions (e.g., visual impairment, hearing impairment; etc.) that would prevent them from following the intervention Subjects will not be excluded if already receiving psychopharmacological therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The CORTEX Project: a Pre-post Randomized Controlled Feasibility Trial Evaluating the Efficacy of a Computerized COgnitive Remediation ThErapy Progeam for Adult Inpatients With anoreXia Nervosa
Background: This study aims to evaluate the feasibility and efficacy of a novel Computer-Assisted Cognitive Remediation Therapy (CA-CRT) program as adjunctive treatment to standard care (TAU) in improving cognitive skills in adult inpatients with anorexia nervosa (AN) Methods: A multicenter randomized controlled trial (RCT) will be conducted to compare the experimental condition with controls receiving TAU only. A minimum sample of 54 subjects with a diagnosis of AN will be recruited in each site. After the initial screening, participants will be randomized to either the experimental group or the control condition. The treatment will last 5 weeks and consists of 10 individual CRT sessions with 15 individual CA-CRT sessions. The impact of the intervention on selected primary and secondary outcomes will be tested at the end of the intervention.
Expected results: We expect subjects assigned to the CA-CRT group to develop more flexible and holistic thinking styles, and achieving increased clinical outcomes.
Read the detailed description
For this reason, the present multicenter Randomized Control Trial (RCT) aims to implement a new CA-CRT for AN (CA-CRT-AN) and to test its feasibility and efficacy as an adjunctive intervention on selected neuropsychological (cognitive flexibility, verbal fluency, visuospatial processing, and attention) and psychological measures (eating disorders, health-related quality of life - HRQoL, and motivation to change) in populations of inpatients with AN following a nutritional rehabilitation program compared to controls following the treatment already used in the clinics (TAU).
Patients with AN will be invited to take part in the study at admission to each rehabilitation center according to the above-mentioned inclusion/exclusion criteria, and those eligible will be randomly assigned to either the experimental (CA-CRT) or control group (TAU).
Before the randomization, they will be asked to sign the informed consent to participate in the research and complete the psychodiagnostic (BAI, BDI II, OCI-R) and psychological (EDE-Q, WHOQOL-BREF, URICA) measures under the supervision of a clinical psychologist independent of the study. The selected neuropsychological measures will be also administered at baseline Randomization will be stratified by center and performed using permuted block technique within each site by a researcher independent of the study. Subjects will be assigned to one of two conditions: both groups received usual hospital care, and the experimental group, in addition, will receive the CA-CRT treatment.
At the end of the treatment (after 5 weeks), subjects in both conditions will be re-administered with neuropsychological tests and psychological measures The total duration of the research will be 6 months, considering a discontinuous enrollment related to the admission to the clinics
- Conditions
- Anorexia Nervosa
- Being tested
- CRT
- Keywords
- Anorexia Nervosa, Cognitive remediation therapy, Randomized controlled trial, Cognitive flexibility, Motivation to change, Quality of life
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRTBehavioural
CA-CRT treatment will entail exercises aimed to improve cognitive strategies, encourage subjects' reflection on their way of thinking, and explore the possibility of implementing new schemas in everyday life. The CA-CRT program will employ a range of cognitive exercises and tasks to address cognitive inflexibility and weak central coherence. The treatment will consist of 10 individual CA-CRT sessions, 2 times per week for 5 weeks, for a duration of 40 minutes per session with 15 individual CA-CRT sessions, 3 times a week for 5 weeks, with a duration of 30 minutes per session
| Study group | Role | What they receive |
|---|---|---|
| CA-CRT | Experimental | Computer-Assisted Cognitive Remediation Therapy Receives: Behavioral: CRT |
| TAU | No intervention | Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
mental flexibility (ability to change rule sets), and problem-solving skills
Wisconsin Card Sorting Test
Measured: pre-pos intervention (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
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.
- 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
- Model description
- CRT involves the completion by patients of a series of tasks on a computer while a trained facilitator engages them in a discussion about the tasks. Patients are encouraged to verbalize their process and to do self-check-ins to gauge their performance
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianluca Castelnuovo, Principal investigator, IRCCS Istituto Auxologico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912036
- Sponsor's protocol ID
- 03C214
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Under request
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CORTEX Project: a Pre-post Randomized Controlled Feasibility Trial Evaluating the Efficacy of a Computerized COgnitive Remediation ThErapy Progeam for Adult Inpatients With anoreXia Nervosa
- ClinicalTrials.gov ID
- NCT05912036
- Acronym / sponsor ID
- 03C214
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Cognitive remediation therapy, Randomized controlled trial, Cognitive flexibility, Motivation to change, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 22 Jun 2023 (actual)
- 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.
Background: This study aims to evaluate the feasibility and efficacy of a novel Computer-Assisted Cognitive Remediation Therapy (CA-CRT) program as adjunctive treatment to standard care (TAU) in improving cognitive skills in adult inpatients with anorexia nervosa (AN) Methods: A multicenter randomized controlled trial (RCT) will be conducted to compare the experimental condition with controls receiving TAU only. A minimum sample of 54 subjects with a diagnosis of AN will be recruited in each site. After the initial screening, participants will be randomized to either the experimental group or the control condition. The treatment will last 5 weeks and consists of 10 individual CRT sessions with 15 individual CA-CRT sessions. The impact of the intervention on selected primary and secondary outcomes will be tested at the end of the intervention.
Expected results: We expect subjects assigned to the CA-CRT group to develop more flexible and holistic thinking styles, and achieving increased clinical outcomes.
Detailed description
For this reason, the present multicenter Randomized Control Trial (RCT) aims to implement a new CA-CRT for AN (CA-CRT-AN) and to test its feasibility and efficacy as an adjunctive intervention on selected neuropsychological (cognitive flexibility, verbal fluency, visuospatial processing, and attention) and psychological measures (eating disorders, health-related quality of life - HRQoL, and motivation to change) in populations of inpatients with AN following a nutritional rehabilitation program compared to controls following the treatment already used in the clinics (TAU).
Patients with AN will be invited to take part in the study at admission to each rehabilitation center according to the above-mentioned inclusion/exclusion criteria, and those eligible will be randomly assigned to either the experimental (CA-CRT) or control group (TAU).
Before the randomization, they will be asked to sign the informed consent to participate in the research and complete the psychodiagnostic (BAI, BDI II, OCI-R) and psychological (EDE-Q, WHOQOL-BREF, URICA) measures under the supervision of a clinical psychologist independent of the study. The selected neuropsychological measures will be also administered at baseline Randomization will be stratified by center and performed using permuted block technique within each site by a researcher independent of the study. Subjects will be assigned to one of two conditions: both groups received usual hospital care, and the experimental group, in addition, will receive the CA-CRT treatment.
At the end of the treatment (after 5 weeks), subjects in both conditions will be re-administered with neuropsychological tests and psychological measures The total duration of the research will be 6 months, considering a discontinuous enrollment related to the admission to the clinics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- CRT involves the completion by patients of a series of tasks on a computer while a trained facilitator engages them in a discussion about the tasks. Patients are encouraged to verbalize their process and to do self-check-ins to gauge their performance
| Arm | Type | Receives |
|---|---|---|
| CA-CRT | Experimental | Behavioral: CRTComputer-Assisted Cognitive Remediation Therapy |
| TAU | No intervention | –Treatment as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CRTCA-CRT treatment will entail exercises aimed to improve cognitive strategies, encourage subjects' reflection on their way of thinking, and explore the possibility of implementing new schemas in everyday life. The CA-CRT program will employ a range of cognitive exercises and tasks to address cognitive inflexibility and weak central coherence. The treatment will consist of 10 individual CA-CRT sessions, 2 times per week for 5 weeks, for a duration of 40 minutes per session with 15 individual CA-CRT sessions, 3 times a week for 5 weeks, with a duration of 30 minutes per session | Behavioural | CA-CRT |
Primary outcome
mental flexibility (ability to change rule sets), and problem-solving skills
Time frame: pre-pos intervention (5 weeks)
Wisconsin Card Sorting Test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Undecided. Under request
Related trials for Anorexia Nervosa
Recruiting
Specialist Supportive Clinical Management (SSCM) for Children and Adolescents With Anorexia Nervosa and Atypical Anorexia Nervosa
Anorexia Nervosa, Atypical Anorexia Nervosa
Not yet recruitingPhase 2
An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa
Anorexia Nervosa
Recruiting
Influence of Control Deprivation on the Use of the Analytical Cognitive Style in Anorexic Subjects
Anorexia Nervosa
Active, not recruiting
A Study on the Effects of Combined FMT on Gut Microbiota and Eating Disorder Symptoms in AN
Anorexia Nervosa
Recruiting
Adapting Exposure for Adolescent AN
Anorexia Nervosa
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.
Gianluca Castelnuovo principal investigator
IRCCS Istituto Auxologico
Questions about this trial
What is this clinical trial studying?
A study testing CRT in people with Anorexia Nervosa, run by Istituto Auxologico Italiano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giada Pietrabissa (+393495324303, giada.pietrabissa@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mental flexibility (ability to change rule sets), and problem-solving skills (time frame: pre-pos intervention (5 weeks)). 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 22 Jun 2023.