The CORTEX Randomized Control Trial

NCT05912036 | Unknown

• 1 other identifier: 03C214
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anorexia Nervosa

Keywords

Anorexia Nervosa; Cognitive remediation therapy; Randomized controlled trial; Cognitive flexibility; Motivation to change; Quality of life

Outcome Measures

Primary Outcomes (1)

• mental flexibility (ability to change rule sets), and problem-solving skills

  Wisconsin Card Sorting Test

  pre-pos intervention (5 weeks)

Study Arms (2)

CA-CRT

EXPERIMENTAL

Computer-Assisted Cognitive Remediation Therapy

Behavioral: CRT

TAU

NO INTERVENTION

Treatment as Usual

Interventions

CRT 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

CA-CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Gianluca Castelnuovo

  IRCCS Istituto Auxologico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giada Pietrabissa

CONTACT

+393495324303; giada.pietrabissa@unicatt.it

Study Design

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

Model Details: 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

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: October 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06