Behavioral Treatments for Anxiety and Depression in Veterans With Parkinson's Disease (BehTA-D)
Primary Purpose
Parkinson Disease, Anxiety, Depression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Anxiety, Depression
Eligibility Criteria
Inclusion Criteria:
- Have a confirmed diagnosis of idiopathic Parkinson's disease
- Have significant anxiety and/or depressive symptoms as indicated by a score of greater than 4 on the Geriatric Depression Scale -15 or greater than 5 on the Hospital Anxiety and Depression anxiety subscale
Exclusion Criteria:
Patients will be excluded if they have cognitive impairment as indicated by the Montreal Cognitive Assessment (MoCA < 23) or if they have a condition that threatens their safety or life including suicidal intent, current psychosis, bipolar, substance abuse or impulse control disorders within the past month.
Sites / Locations
- Michael E. DeBakey Veteran Affairs Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Behavioral Therapy
Arm Description
Outcomes
Primary Outcome Measures
Hospital Anxiety and Depression Scale and Hamilton Anxiety Scale
Hamilton Depression Scale and Geriatric Depression Scale - 15
Secondary Outcome Measures
Parkinson's Disease Questionnaire -8
Client Satisfaction Questionnaire
Full Information
NCT ID
NCT01323699
First Posted
March 25, 2011
Last Updated
April 30, 2013
Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
South Central VA Mental Illness Research, Education & Clinical Center
1. Study Identification
Unique Protocol Identification Number
NCT01323699
Brief Title
Behavioral Treatments for Anxiety and Depression in Veterans With Parkinson's Disease
Acronym
BehTA-D
Official Title
Increasing Access and Implementation of Behavioral Treatments for Anxiety and Depression in Rural Veterans With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
South Central VA Mental Illness Research, Education & Clinical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Behavioral Treatments for Anxiety and Depression (BehTA-D) is a research study for anxiety and depression in individuals with Parkinson's disease (PD). The research clinicians try to teach skills that may help participants cope with anxiety and depression in the context of Parkinson's disease. Research clinicians will also discuss ways improve management of Parkinson's symptoms. Other skills taught include how to relax, change thinking, add in meaningful pleasant activity.
Detailed Description
Components of evidence-based cognitive behavioral therapy (CBT) treatments from current manuals developed for depression and anxiety will be used to construct the 8-week treatment program. The flexibility of modular based treatment allows patients and counselors to personalize interventions and skills for managing anxiety and depressive symptoms. The first treatment session will be in-person. All following sessions will be provided by telephone. Caregivers will have the option of being involved in 2 ways throughout treatment - as a "coach" to facilitate use of new skills by their loved one with PD and as a recipient of stress- management support. The scope of caregiver involvement will vary across patients, based on their preference. Involved caregivers will be given the opportunity to participate in 1 telephone-based stress-management session and 1 follow-up call scheduled individually during the first 4 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Anxiety, Depression
Keywords
Parkinson Disease, Anxiety, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
A modified version of existing Cognitive Behavioral Treatment and Self-management manuals.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale and Hamilton Anxiety Scale
Time Frame
Baseline, 3-months and 4-months
Title
Hamilton Depression Scale and Geriatric Depression Scale - 15
Time Frame
Baseline, 3-months, and 4-months
Secondary Outcome Measure Information:
Title
Parkinson's Disease Questionnaire -8
Time Frame
Baseline, 3-months and 4-months
Title
Client Satisfaction Questionnaire
Time Frame
3-months and 4-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a confirmed diagnosis of idiopathic Parkinson's disease
Have significant anxiety and/or depressive symptoms as indicated by a score of greater than 4 on the Geriatric Depression Scale -15 or greater than 5 on the Hospital Anxiety and Depression anxiety subscale
Exclusion Criteria:
Patients will be excluded if they have cognitive impairment as indicated by the Montreal Cognitive Assessment (MoCA < 23) or if they have a condition that threatens their safety or life including suicidal intent, current psychosis, bipolar, substance abuse or impulse control disorders within the past month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica S Calleo, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey Veteran Affairs Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Behavioral Treatments for Anxiety and Depression in Veterans With Parkinson's Disease
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