Clinical trial NCT01323699: Behavioral Treatments for Anxiety and Depression in Veterans With Parkinson's Disease
Official title: Increasing Access and Implementation of Behavioral Treatments for Anxiety and Depression in Rural Veterans With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parkinson Disease
Anxiety
Depression
Keywords: Parkinson Disease
Anxiety
Depression
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
Collaborators: name: South Central VA Mental Illness Research, Education & Clinical Center
First posted: 2011-03-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale and Hamilton Anxiety Scale
timeFrame: Baseline, 3-months and 4-months
measure: Hamilton Depression Scale and Geriatric Depression Scale - 15
timeFrame: Baseline, 3-months, and 4-months
Secondary outcomes:
measure: Parkinson's Disease Questionnaire -8
timeFrame: Baseline, 3-months and 4-months
measure: Client Satisfaction Questionnaire
timeFrame: 3-months and 4-months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey Veteran Affairs Medical Center
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center
name: Jessica S Calleo, PhD
role: PRINCIPAL_INVESTIGATOR
References: