Clinical High Risk for Psychosis (CHR)CHRTUNISIANCT06582901
Interventions for Clinical High Risk Youth in Tunisia
A study testing Cognitive training (CT) plus the neuropsychological educational approach to cognitive remediation (NEAR) model and an Enhanced - Treatment as Usual (E-TAU) and Enhanced - Treatment as Usual in people with Clinical High Risk for Psychosis (CHR), run by University of California, Los Angeles at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 28 years
- Conditions the study is for
- Clinical High Risk for Psychosis (CHR)
- What is being tested?
- Cognitive training (CT) plus the neuropsychological educational approach to cognitive remediation (NEAR) model and an Enhanced - Treatment as Usual (E-TAU) and Enhanced - Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Sep 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Razi University Hospital
Tunis
Uta Ouali, M.D., +216 716 00 154, uta.ouali@gmail.com
About this study
Official title: Cognitive Training vs. Treatment as Usual to Improve Functioning and Reduce Transition Rates in Tunisian CHR Youth: A Feasibility Study
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.
Read the detailed description
RESEARCH STRATEGY Recruitment of Study Participants Potential study participants are help-seeking youth recruited through the network of trained mental health professionals at schools and universities of the Greater Tunis area (see above) as well as through the CHiRP network at the outpatient departments of Razi University Hospital and Mongi Slim University Hospital.
Randomization to Cognitive Training (CT-NEAR) vs. Enhanced Treatment as Usual (E-TAU) After study entry, patients will be randomized to Cognitive Training (CT-NEAR) or Enhanced Treatment as Usual (E-TAU) using a 1:1 randomization immediately after completion of the baseline assessment battery. Both treatments will last 3 months. Participants in the two conditions will receive treatment which will be carefully tracked and all medication types and doses recorded. The conditions will be matched on all key variables such as amount of therapist and in-clinic time by offering group activities for participants in the E-TAU condition. A clinical and neurocognitive assessment battery will be administered to all participants at baseline by masked assessors. The clinical assessments (symptoms and functioning) will be repeated at 6 weeks (mid-point), and the full assessment battery will be repeated at the 3-month conclusion of the randomized treatment. We will examine the effects of the treatment on neurocognitive functioning, conversion, and role and social functioning.
Cognitive Training Using the Neuropsychological Education Approach to Remediation (CT-NEAR) Enhanced Treatment as Usual Comparison Group The E-TAU condition will consist of regular contact with mental health professionals in the outpatient clinic which involves conducting and monitoring of psychosocial interventions such as Cognitive Behavior Therapy groups for depression and anxiety, case management, supportive counselling, a psychoeducation group, and watching films at home for 30 minutes on a tablet. None of these interventions target improvement in cognition. Participants in the E-TAU condition will receive all of the baseline and follow-up clinical and neurocognitive assessments. The E-TAU condition will be matched for therapist time, group interaction time, and the use of a tablet at home. After the 3-month E-TAU period, participants will be offered participation in the cognitive training and will of course not be included in the CT-NEAR study sample.
Implementation of the Intervention Alignment with National Institute of Mental Health (NIMH) Strategic Plan: The current proposal aligns with several components of the NIMH Strategic Plan 2020.
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Being tested
- Cognitive training (CT) plus the neuropsychological educational approach to cognitive remediation (NEAR) model and an Enhanced - Treatment as Usual (E-TAU), Enhanced - Treatment as Usual
- Keywords
- clinical High Risk youth, cognitive training, enhanced treatment as usual, transition to psychosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive training (CT) plus the neuropsychological educational approach to cognitive remediation (NEAR) model and an Enhanced - Treatment as Usual (E-TAU)Behavioural
Psychosocial interactions computer-based cognitive training (CT) administered in a group setting that includes the Neuropsychological Educational Approach to Cognitive Remediation (NEAR) model:
Enhanced - Treatment as UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Computer Based Cognitive Training (CT) Programs delivered in a group setting using the Neuropsychological Educational Approach to Cognitive Remediation (NEAR) model. Receives: Behavioral: Cognitive training (CT) plus the neuropsychological educational approach to cognitive remediation (NEAR) model and an Enhanced - Treatment as Usual (E-TAU) |
| Enhanced Treatment as Usual | Active comparator | Enhanced 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. Receives: Behavioral: Enhanced - Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months
Secondary outcomes (2)
Global Functioning Scale - Role and Social
Interview-based assessment of work or school functioning and of social functioning. Scores range from 0-100 with higher score indicating better functioning.
Measured: Baseline, 3 months
Comprehensive Assessment of At-Risk Mental States
Interview based assessment of clinical status assess change in clinical status from baseline to post - intervention. The scores range from 0-60 with higher scores indicating worse outcomes.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Sep 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High Risk for Psychosis (CHR)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial (RCT) study that is comparing two interventions: one is experimental and involves computer-based cognitive training using HappyNeuron and the Neuropsychological Educational Approach to Cognitive Remediation (CT-NEAR) model vs Enhanced Treatment as Usual (E-TAU).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ventura, Joseph, University of California, Los Angeles
- Investigators
- Joseph Ventura, Ph.D., Principal investigator, UCLA Department of Psychiatry & Biobehavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582901
- Sponsor's protocol ID
- IRB#23-001029
- Other IDs
- R21MH131319
- Acronym
- CHRTUNISIA
- Status last verified
- Nov 2025
- First submitted
- 30 Aug 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training vs. Treatment as Usual to Improve Functioning and Reduce Transition Rates in Tunisian CHR Youth: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06582901
- Acronym / sponsor ID
- CHRTUNISIA / IRB#23-001029
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Keywords
- clinical High Risk youth, cognitive training, enhanced treatment as usual, transition to psychosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RESEARCH STRATEGY Recruitment of Study Participants Potential study participants are help-seeking youth recruited through the network of trained mental health professionals at schools and universities of the Greater Tunis area (see above) as well as through the CHiRP network at the outpatient departments of Razi University Hospital and Mongi Slim University Hospital.
Randomization to Cognitive Training (CT-NEAR) vs. Enhanced Treatment as Usual (E-TAU) After study entry, patients will be randomized to Cognitive Training (CT-NEAR) or Enhanced Treatment as Usual (E-TAU) using a 1:1 randomization immediately after completion of the baseline assessment battery. Both treatments will last 3 months. Participants in the two conditions will receive treatment which will be carefully tracked and all medication types and doses recorded. The conditions will be matched on all key variables such as amount of therapist and in-clinic time by offering group activities for participants in the E-TAU condition. A clinical and neurocognitive assessment battery will be administered to all participants at baseline by masked assessors. The clinical assessments (symptoms and functioning) will be repeated at 6 weeks (mid-point), and the full assessment battery will be repeated at the 3-month conclusion of the randomized treatment. We will examine the effects of the treatment on neurocognitive functioning, conversion, and role and social functioning.
Cognitive Training Using the Neuropsychological Education Approach to Remediation (CT-NEAR) Enhanced Treatment as Usual Comparison Group The E-TAU condition will consist of regular contact with mental health professionals in the outpatient clinic which involves conducting and monitoring of psychosocial interventions such as Cognitive Behavior Therapy groups for depression and anxiety, case management, supportive counselling, a psychoeducation group, and watching films at home for 30 minutes on a tablet. None of these interventions target improvement in cognition. Participants in the E-TAU condition will receive all of the baseline and follow-up clinical and neurocognitive assessments. The E-TAU condition will be matched for therapist time, group interaction time, and the use of a tablet at home. After the 3-month E-TAU period, participants will be offered participation in the cognitive training and will of course not be included in the CT-NEAR study sample.
Implementation of the Intervention Alignment with National Institute of Mental Health (NIMH) Strategic Plan: The current proposal aligns with several components of the NIMH Strategic Plan 2020.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial (RCT) study that is comparing two interventions: one is experimental and involves computer-based cognitive training using HappyNeuron and the Neuropsychological Educational Approach to Cognitive Remediation (CT-NEAR) model vs Enhanced Treatment as Usual (E-TAU).
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive training (CT) plus the neuropsychological educational approach to cognitive remediation (NEAR) model and an Enhanced - Treatment as Usual (E-TAU)Computer 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 comparator | Behavioral: Enhanced - Treatment as UsualEnhanced 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. |
Who may qualify
- Ages
- 14 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive training (CT) plus the neuropsychological educational approach to cognitive remediation (NEAR) model and an Enhanced - Treatment as Usual (E-TAU)Psychosocial interactions computer-based cognitive training (CT) administered in a group setting that includes the Neuropsychological Educational Approach to Cognitive Remediation (NEAR) model: | Behavioural | Cognitive Training |
| Enhanced - Treatment as UsualThe 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. | Behavioural | Enhanced Treatment as Usual |
Primary outcome
Change in Cognitive Functioning
Time frame: Baseline, 3 months
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.
2 secondary outcomes
Global Functioning Scale - Role and Social
Time frame: Baseline, 3 months
Comprehensive Assessment of At-Risk Mental States
Time frame: Baseline, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Ventura, Ph.D. principal investigator
UCLA Department of Psychiatry & Biobehavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training (CT) plus the neuropsychological educational approach to cognitive remediation (NEAR) model and an Enhanced - Treatment as Usual (E-TAU) and Enhanced - Treatment as Usual in people with Clinical High Risk for Psychosis (CHR), run by University of California, Los Angeles at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Ventura, Ph.D. (310-245-2811, jventura@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Functioning (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.