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The CORTEX Randomized Control Trial

Primary Purpose

Anorexia Nervosa

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CRT
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Cognitive remediation therapy, Randomized controlled trial, Cognitive flexibility, Motivation to change, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CA-CRT

    TAU

    Arm Description

    Computer-Assisted Cognitive Remediation Therapy

    Treatment as Usual

    Outcomes

    Primary Outcome Measures

    mental flexibility (ability to change rule sets), and problem-solving skills
    Wisconsin Card Sorting Test

    Secondary Outcome Measures

    Full Information

    First Posted
    June 12, 2023
    Last Updated
    June 12, 2023
    Sponsor
    Istituto Auxologico Italiano
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05912036
    Brief Title
    The CORTEX Randomized Control Trial
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2024 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Istituto Auxologico Italiano

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anorexia Nervosa
    Keywords
    Anorexia Nervosa, Cognitive remediation therapy, Randomized controlled trial, Cognitive flexibility, Motivation to change, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Participant
    Allocation
    Randomized
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CA-CRT
    Arm Type
    Experimental
    Arm Description
    Computer-Assisted Cognitive Remediation Therapy
    Arm Title
    TAU
    Arm Type
    No Intervention
    Arm Description
    Treatment as Usual
    Intervention Type
    Behavioral
    Intervention Name(s)
    CRT
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    mental flexibility (ability to change rule sets), and problem-solving skills
    Description
    Wisconsin Card Sorting Test
    Time Frame
    pre-pos intervention (5 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Giada Pietrabissa
    Phone
    +393495324303
    Email
    giada.pietrabissa@unicatt.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gianluca Castelnuovo
    Organizational Affiliation
    IRCCS Istituto Auxologico
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Under request

    Learn more about this trial

    The CORTEX Randomized Control Trial

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