Psychosocial Treatment of Depression in Parkinson's Disease

Not Applicable

• Conditions: Major Depressive Disorder; Parkinson's Disease
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT00853346
• Lead Sponsor: Amy Farabaugh, PhD

Brief Summary

The purpose of the study is to examine the effects of a form of talk therapy called cognitive behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's disease (PD).

Detailed Description

CBT is a specific type of treatment that has been shown to be as helpful in treating depression as medications for depression. CBT focuses on thoughts, feelings, and behaviors. It focuses on the here and now, rather than the past. CBT offers concrete strategies and skills for coping with depression, PD, and other life problems. Previous research leads us to believe that this type of therapy may help people with PD cope with their depression.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-02-27
• Study First Submitted QC: 2009-02-27
• Study First Posted: 2009-03-02
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-15
• Last Update Posted: 2012-11-16
• Primary Completion: 2013-04
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

In addition to the DSM-IV diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility:

• Written informed consent.
• Subjects with a primary diagnosis of PD who also currently meet DSM-IV criteria for MDD
• Subjects must be stable on their anti-Parkinson treatment, as defined by no medication changes over the past 6 weeks
• Subjects may be taking an antidepressant as long as they have had a stable dose for up to 6 weeks and do not alter the dosage during the course of the study
• Men or women 40-80 years of age
• HAMD-17 scores > 14 at screen visit
• Score of 25 or greater on the Mini-Mental Status Examination
• Willing to come to MGH for screening and study participation

Exclusion Criteria

Patients meeting any of the following criteria are to be excluded from the study:

• Subjects who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
• Patients who would not be appropriate for a delayed CBT control due to the severity of their depression based on clinical judgment as well as HAMD-17 scores > 28
• The following DSM-IV diagnoses: 1) substance use disorders, including alcohol dependence, active within the last 3 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) MDD with psychotic features
• Subjects who meet DSM-IV criteria for dementia
• Severe, unstable concurrent medical conditions (determined by his/her physician) that are likely to require hospitalization within six months from study entry (e.g., a patient with severe congestive heart failure who has a history of recent hospital admissions)
• Subjects may not be receiving a psychosocial intervention that is specific for depression; psychosocial interventions not specific for depression (e.g., couples counseling) and established for three or more months before screen visit are allowed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cognitive Behavioral Therapy	Patients randomized to the immediate arm will be given 12 weeks of CBT starting one week after randomization
2	Cognitive Behavioral Therapy	Patients in the delayed arm will receive 12 weeks of CBT, starting 12 weeks after randomization.

Primary Outcome Measures

Name	Time	Method
Response according to the Hamilton Rating Scale for Depression, 17 items (HAM-D 17).	screen, week 4, week 8, week 12; if applicable, week 16, week 20, week 24

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States