Psychosocial Treatment of Depression in Parkinson's Disease

NCT00853346 | Unknown DMC

• 1 other identifier: MH076037-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Disorder; Parkinson's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy

2

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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

Also known as: CBT, Cognitive Therapy, Therapy, Psychosocial Intervention

1

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amy Farabaugh, PhD: lead
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Parkinson Disease; Depression

Interventions

Cognitive Behavioral Therapy; Therapeutics; Psychosocial Intervention

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Amy Farabaugh, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Psychotherapy Research, Depression Clinical & Research Program

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Study Start: April 1, 2007
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

US (1)