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

Depression Clinical Trial

— BehTA-D  

Official title:

Increasing Access and Implementation of Behavioral Treatments for Anxiety and Depression in Rural Veterans With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323699
• Other study ID #: H-28002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 25, 2011
• Last updated: April 30, 2013
• Start date: November 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: Michael Debakey Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Parkinson Disease

Intervention

Behavioral:
• Cognitive Behavioral Therapy
A modified version of existing Cognitive Behavioral Treatment and Self-management manuals.

Locations

Country	Name	City	State
United States	Michael E. DeBakey Veteran Affairs Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Michael Debakey Veterans Affairs Medical Center	South Central VA Mental Illness Research, Education & Clinical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale and Hamilton Anxiety Scale		Baseline, 3-months and 4-months	No
Primary	Hamilton Depression Scale and Geriatric Depression Scale - 15		Baseline, 3-months, and 4-months	No
Secondary	Parkinson's Disease Questionnaire -8		Baseline, 3-months and 4-months	No
Secondary	Client Satisfaction Questionnaire		3-months and 4-months	No