Psychosocial Treatment of Depression in Parkinson's Disease

NCT ID: NCT00853346

Last Updated: 2012-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2013-04-30

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.

Conditions

Major Depressive Disorder; Parkinson's Disease

Keywords

Depression; Parkinson's Disease; Major Depression; Cognitive Behavioral Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Patients randomized to the immediate arm will be given 12 weeks of CBT starting one week after randomization

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression

2

Patients in the delayed arm will receive 12 weeks of CBT, starting 12 weeks after randomization.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression

Interventions

Cognitive Behavioral Therapy

12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy

12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT; Cognitive Therapy; Therapy; Psychosocial Intervention; CBT; Cognitive Therapy; Therapy; Psychosocial Intervention

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Amy Farabaugh, PhD

OTHER

Sponsor Role: lead

Responsible Party

Amy Farabaugh, PhD

Director, Psychotherapy Research, Depression Clinical & Research Program

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amy Farabaugh, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

MH076037-01

Identifier Type: -

Identifier Source: org_study_id