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Behavioral Treatments for Anxiety and Depression in Veterans With Parkinson's Disease (BehTA-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01323699
Recruitment Status : Completed
First Posted : March 28, 2011
Last Update Posted : May 1, 2013
South Central VA Mental Illness Research, Education & Clinical Center
Information provided by (Responsible Party):
Jessica Calleo, Michael Debakey Veterans Affairs 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Anxiety Depression Behavioral: Cognitive Behavioral Therapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Increasing Access and Implementation of Behavioral Treatments for Anxiety and Depression in Rural Veterans With Parkinson's Disease
Study Start Date : November 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Behavioral Therapy Behavioral: Cognitive Behavioral Therapy
A modified version of existing Cognitive Behavioral Treatment and Self-management manuals.

Primary Outcome Measures :
  1. Hospital Anxiety and Depression Scale and Hamilton Anxiety Scale [ Time Frame: Baseline, 3-months and 4-months ]
  2. Hamilton Depression Scale and Geriatric Depression Scale - 15 [ Time Frame: Baseline, 3-months, and 4-months ]

Secondary Outcome Measures :
  1. Parkinson's Disease Questionnaire -8 [ Time Frame: Baseline, 3-months and 4-months ]
  2. Client Satisfaction Questionnaire [ Time Frame: 3-months and 4-months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01323699

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United States, Texas
Michael E. DeBakey Veteran Affairs Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Michael Debakey Veterans Affairs Medical Center
South Central VA Mental Illness Research, Education & Clinical Center
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Principal Investigator: Jessica S Calleo, PhD Michael Debakey Veterans Affairs Medical Center
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Responsible Party: Jessica Calleo, Clinical Psychologist, Michael Debakey Veterans Affairs Medical Center Identifier: NCT01323699    
Other Study ID Numbers: H-28002
First Posted: March 28, 2011    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013
Keywords provided by Jessica Calleo, Michael Debakey Veterans Affairs Medical Center:
Parkinson Disease
Additional relevant MeSH terms:
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Parkinson Disease
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases