Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158301
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2005-09-07
Brief Title:
Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Continuation Phase CBT for Youth With MDD
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children
Detailed Description:
Depression is a chronic and episodic condition that may have devastating effects on social and emotional functioning particularly in the pediatric population While approximately 90 of children eventually recover from an episode of depression up to 40 of those children relapse within 1 to 2 years Data indicate that cognitive behavioral therapy CBT delivered after depressive symptoms subside can significantly reduce depression relapses in adults However there are no comparable studies in children or adolescents This study will determine whether CBT is effective in reducing a relapse of depressive episodes in children and adolescents with major depression
This study comprises two phases In Phase 1 all participants will receive drug treatment for 12 weeks Participants who respond to the treatment will complete the study after 12 weeks Participants whose depression symptoms return after 12 weeks will be enrolled in Phase 2 In Phase 2 participants will be randomly assigned to either continue drug therapy alone or to receive drug therapy plus CBT for 6 months The CBT will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms Self-report scales will be used to assess the depressive symptoms of participants who complete Phases 1 and 2 at study entry and at the end of the study
This study comprises two phases In Phase 1 all participants will receive drug treatment for 12 weeks Participants who respond to the treatment will complete the study after 12 weeks Participants whose depression symptoms return after 12 weeks will be enrolled in Phase 2 In Phase 2 participants will be randomly assigned to either continue drug therapy alone or to receive drug therapy plus CBT for 6 months The CBT will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms Self-report scales will be used to assess the depressive symptoms of participants who complete Phases 1 and 2 at study entry and at the end of the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR 84-CTS | US NIH GrantContract | None | httpsreporternihgovquickSearchR34MH072737 |
| R34MH072737 | NIH | None | None |