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

This study has been completed.
Sponsor:
Collaborator:
South Central VA Mental Illness Research, Education & Clinical Center
Information provided by (Responsible Party):
Jessica Calleo, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01323699
First received: March 25, 2011
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Parkinson Disease
Anxiety
Depression
Behavioral: Cognitive Behavioral Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Michael Debakey Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Hospital Anxiety and Depression Scale and Hamilton Anxiety Scale [ Time Frame: Baseline, 3-months and 4-months ] [ Designated as safety issue: No ]
  • Hamilton Depression Scale and Geriatric Depression Scale - 15 [ Time Frame: Baseline, 3-months, and 4-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parkinson's Disease Questionnaire -8 [ Time Frame: Baseline, 3-months and 4-months ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire [ Time Frame: 3-months and 4-months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Therapy Behavioral: Cognitive Behavioral Therapy
A modified version of existing Cognitive Behavioral Treatment and Self-management manuals.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323699

Locations
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
Investigators
Principal Investigator: Jessica S Calleo, PhD Michael E. DeBakey Veteran Affairs Medical Center
  More Information

No publications provided

Responsible Party: Jessica Calleo, Clinical Psychologist, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01323699     History of Changes
Other Study ID Numbers: H-28002
Study First Received: March 25, 2011
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Michael Debakey Veterans Affairs Medical Center:
Parkinson Disease
Anxiety
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Parkinson Disease
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

ClinicalTrials.gov processed this record on September 18, 2014