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

NCT01323699 | Completed Phase 1

• 1 other identifier: H-28002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Anxiety; Depression

Keywords

Parkinson Disease; Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• Hospital Anxiety and Depression Scale and Hamilton Anxiety Scale

  Baseline, 3-months and 4-months

• Hamilton Depression Scale and Geriatric Depression Scale - 15

  Baseline, 3-months, and 4-months

Secondary Outcomes (2)

• Parkinson's Disease Questionnaire -8

  Baseline, 3-months and 4-months

• Client Satisfaction Questionnaire

  3-months and 4-months

Study Arms (1)

Behavioral Therapy

EXPERIMENTAL

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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

Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael E. DeBakey VA Medical Center: lead
• South Central VA Mental Illness Research, Education & Clinical Center: collaborator

Study Sites (1)

Michael E. DeBakey Veteran Affairs Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Anxiety Disorders; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jessica S Calleo, PhD

  Michael E. DeBakey VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: March 28, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

US (1)