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Psychosocial Treatment of Depression in Parkinson's Disease

Primary Purpose

Major Depressive Disorder, Parkinson's Disease

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Parkinson's Disease, Major Depression, Cognitive Behavioral Therapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Response according to the Hamilton Rating Scale for Depression, 17 items (HAM-D 17).

Secondary Outcome Measures

Full Information

NCT ID

NCT00853346

First Posted

February 27, 2009

Last Updated

November 15, 2012

Sponsor

Amy Farabaugh, PhD

Collaborators

Brigham and Women's Hospital, Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00853346

Brief Title

Psychosocial Treatment of Depression in Parkinson's Disease

Official Title

Psychosocial Treatment of Depression in Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

April 2013 (Anticipated)

Study Completion Date

April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Amy Farabaugh, PhD

Collaborators

Brigham and Women's Hospital, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder, Parkinson's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy

Other Intervention Name(s)

CBT, Cognitive Therapy, Therapy, Psychosocial Intervention

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy

Other Intervention Name(s)

CBT, Cognitive Therapy, Therapy, Psychosocial Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy Farabaugh, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

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Psychosocial Treatment of Depression in Parkinson's Disease

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