Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532500
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
I-CARE A Pilot Study of Cognitive Behavioural TherapyCBT for Mood and Anxiety Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
I-CARE A Pilot Study of Cognitive Behavioural TherapyCBT for Mood and Anxiety Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
I-CARE
Brief Summary:
The goal of this clinical trial is to learn if CBTCognitive Behavioural Therapy-MyOWLOptimizing Wellness through Literature is feasible leads to better patient retention and has high acceptability by youth psychiatric outpatients with mood andor anxiety disorder aged 14-19 The main questions it aims to answer are
Primary Objective feasibility To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL CBT-as-usual
Primary Objective acceptability To determine whether the CBT-MyOWL and CBT-as-usual interventions delivered are acceptable to youth participants
Secondary Objectives
1 To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual
2 To determine whether youth who receive CBT-MyOWL have improved scores on all of the following over the course of treatment and endpoint compared to youth who receive CBT-as usual i depression and anxiety ii suicidal ideation iii self-harm and iv coping and emotional resiliency
Participants will
Participate in 12 sessions of either CBT-MyOWL or CBT-as-usual active control Completes 4-5 questionnaires at sessions 36912 Complete the acceptability and exit interview at session 12
Primary Objective feasibility To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL CBT-as-usual
Primary Objective acceptability To determine whether the CBT-MyOWL and CBT-as-usual interventions delivered are acceptable to youth participants
Secondary Objectives
1 To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual
2 To determine whether youth who receive CBT-MyOWL have improved scores on all of the following over the course of treatment and endpoint compared to youth who receive CBT-as usual i depression and anxiety ii suicidal ideation iii self-harm and iv coping and emotional resiliency
Participants will
Participate in 12 sessions of either CBT-MyOWL or CBT-as-usual active control Completes 4-5 questionnaires at sessions 36912 Complete the acceptability and exit interview at session 12
Detailed Description:
None
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