Ignite Creation Date:
2024-05-05 @ 9:11 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00830011
Status:
COMPLETED
Last Update Posted:
2011-07-28
First Post:
2009-01-24
Brief Title:
Cognitive Behavioral Therapy for Painful Diabetic Neuropathy
Sponsor:
VA Connecticut Healthcare System
Organization:
VA Connecticut Healthcare System
Study Overview
Official Title:
Cognitive Behavioral Therapy for Painful Diabetic Neuropathy
Status:
COMPLETED
Status Verified Date:
2011-07
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:
The primary objective of this study is to evaluate the usefulness of cognitive behavioral therapy CBT for the management of painful diabetic neuropathy Participants will be randomly assigned to one of two treatment conditions CBT plus standard medical care or standard medical care alone CBT will be offered in ten ninety-minute group sessions and will be provided by a psychologist with experience in the management of both diabetes and chronic pain CBT will involve teaching and encouraging practice of adaptive pain coping skills such as relaxation skills activity pacing and positive self-statements among others This study will allow us to determine which treatment is superior in terms of improvements in pain management functioning and overall quality of life
Detailed Description:
Research Design A randomized mixed factorial controlled design will be employed in which CBT plus standard pharmaceutical care CBTSC is compared to a standard pharmaceutical care SC treatment condition Participants will be randomized in equal numbers to the two conditions Repeated assessments of key outcome domains will occur at pretreatmentbaseline and at 12 24 and 36 weeks following baseline
Methodology Study participants will be evaluated pre-treatment baseline 12 weeks post-baseline post-treatment and at 24 and 36 weeks post-baseline follow-up Baseline assessment will include a neurological examination with a nerve conduction study to confirm the diagnosis of diabetic neuropathy The primary outcome measure will be pain intensity Secondary outcome measures will be pain quality pain-related disability physical and emotional functioning Measures of treatment feasibility will also be examined Participants receiving CBT will attend 10 weekly group treatment sessions of 90 minutes A target sample size of approximately 120 participants will be recruited
Methodology Study participants will be evaluated pre-treatment baseline 12 weeks post-baseline post-treatment and at 24 and 36 weeks post-baseline follow-up Baseline assessment will include a neurological examination with a nerve conduction study to confirm the diagnosis of diabetic neuropathy The primary outcome measure will be pain intensity Secondary outcome measures will be pain quality pain-related disability physical and emotional functioning Measures of treatment feasibility will also be examined Participants receiving CBT will attend 10 weekly group treatment sessions of 90 minutes A target sample size of approximately 120 participants will be recruited
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 |
|---|---|---|---|
| DF03-35 | None | None | None |