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Official Study Title: Psychosocial Treatment of Depression in Parkinson's Disease
Sponsor: National Institute of Mental Health (NIMH)
Clinicaltrials.gov ID:
Study ID: 1K23MH076037-01A2

Summary

Within Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD), depression is a major health problem and often goes undiagnosed and untreated. It has been shown that depression greatly impacts an individual's quality of life, more so than even the motor disability. Depression is hard to treat in the context of PD, in part because medications for depression may possibly interact with Parkinson's medications. A psychosocial intervention, such as cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. behavior therapy,  TherapyAnother word for “treatment”. has the potential to effectively address symptoms of depression, and has the potential to address PD symptoms that may or may not be related to depression, such as anxiety, sleep issues, and cognitive/motor challenges. The psychotherapy of depression in PD is an exceptionally important and inadequately studied area. The present study will randomize, that is, assign by chance, like the flip of a coin, individuals with PD, who also have symptoms of depression, to either 12 weeks of individual therapy (cognitive behavior therapy) or to a wait-list/delayed therapy group. Both groups will receive therapy, either immediately or delayed by 12 weeks. The therapy is individual therapy and will be provided once a week. The therapy will provide participants with concrete strategies and skills for coping with depression and other non-motor symptoms  Non-Motor SymptomsContribute to severe disability and impaired quality of life in advanced Parkinson's disease. Symptoms include anxiety, depression, cognitive mood swings, dementia, constipation, pain, genitourinary problems, sudden drop in blood pressure upon standing (orthostatic hypotension), excessive sweating, and sleep disturbances, sense of smell, vision, memory, weight loss, psychosis, hallucinations, and loss of energy. of PD, such as anxiety and loss of concentration.

Study Phase

Not Specified
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Depression

Time Commitment

• Less than six months
• Twelve weeks if participant receives therapy from the beginning, and 24 weeks if participant receives therapy after a wait period. One visit per week while in therapy, and one visit per month while in the wait period.

Eligibility

• Minimum Age: 40
• Maximum Age: 75
• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosis of PD

Exclusion Criteria

• Dementia
• Severe unstable medical conditions
• Those already receiving psychotherapy for depression

Enrollment

Expected Enrollment: 80 (US)
Date Enrollment Began: Jun 2007
Date Enrollment Ends: Jun 2012
Last Updated Date: Sep 23 2008
Trial Post Date: Sep 27 2007
Website:

Primary Contacts and Locations

Massachusetts

• Amy Farabaugh, PhD — Principal Investigator
  Massachusetts General Hospital
  afarabaugh@partners.org
  Phone: (617) 726-1629
  50 Staniford Street
  4th floor, Suite 401
  Boston, MA 02114
  USA