MedTrace Logo

The CORTEX Randomized Control Trial

NCT05912036 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-06-22

No results posted yet for this study

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

Interventions

BEHAVIORAL

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

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Gianluca Castelnuovo · IRCCS Istituto Auxologico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-05-31
Completion
2024-05-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05912036 on ClinicalTrials.gov