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

NCT ID: NCT01323699

Last Updated: 2013-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-02-28

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.

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.

Conditions

Parkinson Disease; Anxiety; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Therapy

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive Behavioral Therapy

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Central VA Mental Illness Research, Education & Clinical Center

FED

Sponsor Role: collaborator

Michael E. DeBakey VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Jessica Calleo

Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica S Calleo, PhD

Role: PRINCIPAL_INVESTIGATOR

Michael E. DeBakey VA Medical Center

Locations

Michael E. DeBakey Veteran Affairs Medical Center

Houston, Texas, United States

Countries

United States

Other Identifiers

H-28002

Identifier Type: -

Identifier Source: org_study_id