Behavioral Treatments for Anxiety and Depression in Veterans With Parkinson's Disease

Phase 1

Completed

• Conditions: Parkinson Disease; Anxiety; Depression
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT01323699
• Lead Sponsor: Michael E. DeBakey VA Medical Center

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.

Study Timeline

• Study First Submitted: 2011-03-25
• Study First Submitted QC: 2011-03-25
• Study First Posted: 2011-03-28
• Study Start: 2011-11
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-30
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Have a confirmed diagnosis of idiopathic Parkinson's disease
2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral Therapy	Cognitive Behavioral Therapy	-

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale and Hamilton Anxiety Scale	Baseline, 3-months and 4-months
Hamilton Depression Scale and Geriatric Depression Scale - 15	Baseline, 3-months, and 4-months

Secondary Outcome Measures

Name	Time	Method
Parkinson's Disease Questionnaire -8	Baseline, 3-months and 4-months
Client Satisfaction Questionnaire	3-months and 4-months

Trial Locations

Locations (1)

Michael E. DeBakey Veteran Affairs Medical Center; 🇺🇸 Houston, Texas, United States