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CompletedNCT01323699BehTA-DUpdated May 1, 2013

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

A Phase 1/2 interventional study of Cognitive Behavioral Therapy in Parkinson Disease, Anxiety and Depression, sponsored by Michael E. DeBakey VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-01.

Sponsored by Michael E. DeBakey VA Medical Center · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease
  • Anxiety
  • Depression

Keywords

  • Parkinson Disease
  • Anxiety
  • Depression
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's enrollment of 20 is below the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Michael E. DeBakey VA Medical Center is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Behavioral Therapy

    Behavioral: Cognitive Behavioral Therapy

Interventions

  • BehavioralCognitive Behavioral Therapy

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

06

What researchers measure

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

07

Study locations

1 site
  • Michael E. DeBakey Veteran Affairs Medical Center
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01323699
Lead sponsor
Michael E. DeBakey VA Medical Center
Collaborators
South Central VA Mental Illness Research, Education & Clinical Center
Responsible party
Jessica Calleo (Clinical Psychologist, Michael E. DeBakey VA Medical Center) — Principal investigator
First posted
Mar 28, 2011
Start date
Nov 2011
Primary completion
Feb 2013
Completion
Feb 2013
Last update
May 1, 2013

Study contacts

Jessica S Calleo, PhD
principal investigator · Michael E. DeBakey VA Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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