The CORTEX Randomized Control Trial

NCT ID: NCT05912036

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-05-31

Brief 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 (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

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CA-CRT

Computer-Assisted Cognitive Remediation Therapy

Group Type: EXPERIMENTAL

CRT

Intervention Type: BEHAVIORAL

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

TAU

Treatment as Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CRT

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianluca Castelnuovo

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Auxologico

Central Contacts

Giada Pietrabissa

Role: CONTACT

giada.pietrabissa@unicatt.it

+393495324303

Other Identifiers

03C214

Identifier Type: -

Identifier Source: org_study_id