Interventions for Clinical High Risk Youth in Tunisia

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.

• Cognitive training (CT) plus the neuropsychological educational approach to cognitive remediation (NEAR) model and an Enhanced - Treatment as Usual (E-TAU) (Behavioral): 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 Usual (Behavioral): 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.

Primary outcomes

• Change in Cognitive Functioning [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.

Secondary outcomes

• Global Functioning Scale - Role and Social [Baseline, 3 months]: Interview-based assessment of work or school functioning and of social functioning. Scores range from 0-100 with higher score indicating better functioning.
• Comprehensive Assessment of At-Risk Mental States [Baseline, 3 months]: 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.

Sex: All, ages: 14 Years to 28 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

• Joseph Ventura, Ph.D., Principal investigator, UCLA Department of Psychiatry & Biobehavioral Sciences

NIH grants: R21MH131319