Interventions for Clinical High Risk Youth in Tunisia
CHRTUNISIA
Cognitive Training vs. Treatment as Usual to Improve Functioning and Reduce Transition Rates in Tunisian CHR Youth: A Feasibility Study
2 other identifiers
interventional
54
1 country
1
Brief Summary
Study participants will take part in one of the two types of treatments aimed at improving daily functioning as follows: either a Cognitive Training (CT) Program or an Enhanced - Treatment as Usual (E-TAU) Group. All group treatments will be provided at Razi Hospital and one of the sessions will be conducted at home. The Cognitive (thinking skills) Training and Neuropsychological Education Approach to Remediation (CT-NEAR) is a form of cognitive (thinking skills) training that consists of computer-game like brain exercises, learning about thinking skills strategies, and a "bridging group" to help participants use what is learned in daily life. Cognitive exercises are generally fun and playful and are done on a computer. The aim is to train thinking skills and ability to function better in daily life such as at school, university, or at work, or with friends and family. The program lasts 12 weeks with two weekly sessions in groups of 3 to 4 participants. Each session is 1½ hours in length and one of the sessions is which lasts 30 minutes is conducted at home using a tablet that will be provided by the study investigators.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 30, 2024
CompletedFirst Posted
Study publicly available on registry
September 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedNovember 25, 2025
November 1, 2025
2 years
August 30, 2024
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Cognitive Functioning
Neurocognitive Test Battery. Scored on a composite of various cognitive tests will indicate improved, not improved at follow-up. The composite score ranges from 0 to 50 with higher scores indicating greater improvement.
Baseline, 3 months
Secondary Outcomes (2)
Global Functioning Scale - Role and Social
Baseline, 3 months
Comprehensive Assessment of At-Risk Mental States
Baseline, 3 months
Study Arms (2)
Cognitive Training
EXPERIMENTALComputer Based Cognitive Training (CT) Programs delivered in a group setting using the Neuropsychological Educational Approach to Cognitive Remediation (NEAR) model.
Enhanced Treatment as Usual
ACTIVE COMPARATOREnhanced Treatment as Usual (E-TAU) sessions are delivered in a group therapy format and guided by the principles of Cognitive Behavioral Therapy (CBT). The E-TAU sessions focus on helping individuals identify and change negative thought patterns and behaviors that contribute to emotional distress and mental health issues.
Interventions
Psychosocial interactions computer-based cognitive training (CT) administered in a group setting that includes the Neuropsychological Educational Approach to Cognitive Remediation (NEAR) model:
The Enhanced-Treatment as Usual (E-TAU) sessions are delivered in a group therapy format and guided by the principles of Cognitive Behavioral Therapy (CBT). Participants learn to develop coping skills and are educated on how to improve distortions to reduce anxiety and depression.
Eligibility Criteria
You may qualify if:
- Meets Comprehensive Assessment for At Risk Mental States (CAARMS) criteria for Clinical High Risk
- If under the age of 18, the subject has a parent or guardian who can sign consent forms
- Premorbid Intelligence Quotient not less than 70
- Sufficient fluency in Arabic, French, or English to avoid invalidating research measures
- Residence likely within commuting distance of Razi University Hospital
You may not qualify if:
- Evidence of known neurological disorder, e.g. epilepsy or significant head injury that could account for the CHR symptoms
- Evidence of significant and habitual alcohol or substance use in the 6 months prior to study entry
- Evidence that the clinical high-risk symptoms were substance-induced
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Razi University Hospital
Tunis, Tunisia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Ventura, Ph.D.
UCLA Department of Psychiatry & Biobehavioral Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- One clinical rater will be unaware of the treatment condition
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 30, 2024
First Posted
September 3, 2024
Study Start
September 1, 2023
Primary Completion
August 31, 2025
Study Completion (Estimated)
August 31, 2026
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share