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Completed

NCT Number: NCT01323699

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Michael E. DeBakey Veteran Affairs Medical Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Michael E. DeBakey VA Medical Center

Fed

Collaborators

  • South Central VA Mental Illness Research, Education & Clinical Center

Registry information

Official study title

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

Acronym: BehTA-D

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 28, 2011
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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