Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464464
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2007-04-20
Brief Title:
Coping With Depression in Parkinsons Disease
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Treating Depression in Parkinsons Disease A New Method
Status:
COMPLETED
Status Verified Date:
2014-11
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:
The purpose of this study is to evaluate the efficacy of a cognitive-behavioral treatment that includes a caregiver-focused social support intervention for depression in persons with Parkinsons disease
Individuals who are unable to travel to the study site but are interested in participating and meet all other eligibility requirements will be allowed to participate over the phone
Individuals who are unable to travel to the study site but are interested in participating and meet all other eligibility requirements will be allowed to participate over the phone
Detailed Description:
Depression is the most common emotional problem found in persons with Parkinsons disease PD It causes immense personal suffering and is associated with increased disability and burden to caregivers Despite the adverse consequences of depression in PD there are virtually no studies to guide clinical treatment Several studies are currently examining the effectiveness of antidepressant medication for depression in PD However there have been no studies to examine the effectiveness of non-medication approaches such as cognitive-behavioral therapy despite the success of these techniques in other populations Cognitive-behavioral therapy teaches people with PD to become more aware of their thoughts and feelings and to change thinking patterns and behaviors that may be related to symptoms of depression
The purpose of this study is to determine if cognitive-behavioral therapy--with a caregiver-focused social support intervention--is effective in treating depression in persons with PD This study will enroll 80 people with PD and their caregivers Forty participants with PD will be randomly chosen to receive the study treatment in addition to standard medical care The other 40 will only receive standard medical care and will have the option to receive the study treatment after completing all study assessments 4 months after the initial evaluation
The study treatment will consist of 10 weekly individual cognitive-behavioral treatment sessions lasting 1 hour each and modified to meet the unique needs of each individual with PD Caregivers will attend 4 separate educational sessions-lasting 30 minutes each--designed to provide them with the tools needed to reinforce and supplement the material presented in the cognitive-behavioral sessions Duration of the study for participants is 15 weeks
This is the first study to evaluate the impact of a cognitive-behavioral treatment for PD depression in a randomized controlled trial Information gained from this study may be beneficial in treating depression in persons with PD
The purpose of this study is to determine if cognitive-behavioral therapy--with a caregiver-focused social support intervention--is effective in treating depression in persons with PD This study will enroll 80 people with PD and their caregivers Forty participants with PD will be randomly chosen to receive the study treatment in addition to standard medical care The other 40 will only receive standard medical care and will have the option to receive the study treatment after completing all study assessments 4 months after the initial evaluation
The study treatment will consist of 10 weekly individual cognitive-behavioral treatment sessions lasting 1 hour each and modified to meet the unique needs of each individual with PD Caregivers will attend 4 separate educational sessions-lasting 30 minutes each--designed to provide them with the tools needed to reinforce and supplement the material presented in the cognitive-behavioral sessions Duration of the study for participants is 15 weeks
This is the first study to evaluate the impact of a cognitive-behavioral treatment for PD depression in a randomized controlled trial Information gained from this study may be beneficial in treating depression in persons with PD
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