Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582901
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Interventions for Clinical High Risk Youth in Tunisia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cognitive Training Vs Treatment As Usual to Improve Functioning and Reduce Transition Rates in Tunisian CHR Youth a Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHRTUNISIA
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
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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None