Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188838
Status:
UNKNOWN
Last Update Posted:
2005-09-16
First Post:
2005-09-12
Brief Title:
Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
Status:
UNKNOWN
Status Verified Date:
2005-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
To examine the impact of cognitive-behavioural therapy on both the episodic and functional outcome of bipolar disorder in combination with pharmacotherapy
Primary Hypothesis is twofold
1 Cognitive Behavioural Therapy will reduce the total symptom burden as measured both by percentage of time spent ill both syndromic and subsyndromal and number of episodes as compared to psychoeducation
2 Cognitive behavioural therapy will reduce social and occupational disability to a greater extent than psychoeducation
Primary Hypothesis is twofold
1 Cognitive Behavioural Therapy will reduce the total symptom burden as measured both by percentage of time spent ill both syndromic and subsyndromal and number of episodes as compared to psychoeducation
2 Cognitive behavioural therapy will reduce social and occupational disability to a greater extent than psychoeducation
Detailed Description:
Objective
To compare the impact of cognitive -behavioral therapy to that of properly structured psycho education on the illness burden and functional outcome of bipolar disorder in combination with pharmacotherapy
Interventions
Subjects will be randomized to either a control treatment group cosisting of 6 sessions of group psycho-education topics include illness recognition treatment approaches and monitoring and coping strategies based on manual by Bauer McBride 2002 Life Goals Phase I or they will be randomized to the experimental treatment group 20 sessions of individual Cognitive Behavioural Therapy for Bipolar Disorder topics include limited psychoeducation activity schedulingbehavioural interventions cognitive techniques including thought monitoring and challenges to dysfunctional assumptions and other coping techniques based on manual by Lam et al 1999 Cognitive Therapy for Bipolar Disorder
To compare the impact of cognitive -behavioral therapy to that of properly structured psycho education on the illness burden and functional outcome of bipolar disorder in combination with pharmacotherapy
Interventions
Subjects will be randomized to either a control treatment group cosisting of 6 sessions of group psycho-education topics include illness recognition treatment approaches and monitoring and coping strategies based on manual by Bauer McBride 2002 Life Goals Phase I or they will be randomized to the experimental treatment group 20 sessions of individual Cognitive Behavioural Therapy for Bipolar Disorder topics include limited psychoeducation activity schedulingbehavioural interventions cognitive techniques including thought monitoring and challenges to dysfunctional assumptions and other coping techniques based on manual by Lam et al 1999 Cognitive Therapy for Bipolar Disorder
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