Psychosocial Treatment of Depression in Parkinson's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Amy Farabaugh, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00853346
First received: February 27, 2009
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention
Major Depressive Disorder
Parkinson's Disease
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychosocial Treatment of Depression in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Response according to the Hamilton Rating Scale for Depression, 17 items (HAM-D 17). [ Time Frame: screen, week 4, week 8, week 12; if applicable, week 16, week 20, week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2007
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients randomized to the immediate arm will be given 12 weeks of CBT starting one week after randomization
Behavioral: Cognitive Behavioral Therapy
12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression
Other Names:
  • CBT
  • Cognitive Therapy
  • Therapy
  • Psychosocial Intervention
Active Comparator: 2
Patients in the delayed arm will receive 12 weeks of CBT, starting 12 weeks after randomization.
Behavioral: Cognitive Behavioral Therapy
12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression
Other Names:
  • CBT
  • Cognitive Therapy
  • Therapy
  • Psychosocial Intervention

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853346

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Amy Farabaugh, PhD
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Amy Farabaugh, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Amy Farabaugh, PhD, Director, Psychotherapy Research, Depression Clinical & Research Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00853346     History of Changes
Other Study ID Numbers: MH076037-01
Study First Received: February 27, 2009
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Depression
Parkinson's Disease
Major Depression
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Parkinson Disease
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 15, 2014