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Coping With Depression in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00464464
Recruitment Status : Completed
First Posted : April 23, 2007
Results First Posted : November 5, 2014
Last Update Posted : November 5, 2014
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE April 20, 2007
First Posted Date  ICMJE April 23, 2007
Results First Submitted Date  ICMJE March 10, 2014
Results First Posted Date  ICMJE November 5, 2014
Last Update Posted Date November 5, 2014
Study Start Date  ICMJE April 2007
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
  • Hamilton Depression Rating Scale: Baseline [ Time Frame: 0 weeks ]
    This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the outset of the trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.
  • Hamilton Depression Rating Scale: Midpoint [ Time Frame: 5 weeks ]
    This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, after 5 weeks of the trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.
  • Hamilton Depression Rating Scale: Endpoint [ Time Frame: 10 weeks ]
    This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the end of the 10 week trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.
  • Hamilton Depression Rating Scale: Follow-Up Evaluation [ Time Frame: 14 weeks ]
    This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, 4 weeks after the trial ended. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2007)
Hamilton Rating Scale for Depression.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2007)
Several secondary outcomes to assess depression, anxiety, sleep, quality of life, social support, caregiver distress, and neuropsychological functioning.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coping With Depression in Parkinson's Disease
Official Title  ICMJE Treating Depression in Parkinson's Disease: A New Method
Brief Summary

The purpose of this study is to evaluate the efficacy of a cognitive-behavioral treatment, that includes a caregiver-focused social support intervention, for depression in persons with Parkinson's disease.

Individuals who are unable to travel to the study site, but are interested in participating and meet all other eligibility requirements, will be allowed to participate over the phone.

Detailed Description

Depression is the most common emotional problem found in persons with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and burden to caregivers. Despite the adverse consequences of depression in PD, there are virtually no studies to guide clinical treatment. Several studies are currently examining the effectiveness of antidepressant medication for depression in PD. However, there have been no studies to examine the effectiveness of non-medication approaches, such as cognitive-behavioral therapy, despite the success of these techniques in other populations. Cognitive-behavioral therapy teaches people with PD to become more aware of their thoughts and feelings and to change thinking patterns and behaviors that may be related to symptoms of depression.

The purpose of this study is to determine if cognitive-behavioral therapy--with a caregiver-focused social support intervention--is effective in treating depression in persons with PD. This study will enroll 80 people with PD and their caregivers. Forty participants with PD will be randomly chosen to receive the study treatment in addition to standard medical care. The other 40 will only receive standard medical care and will have the option to receive the study treatment after completing all study assessments (4 months after the initial evaluation).

The study treatment will consist of 10 weekly individual cognitive-behavioral treatment sessions, lasting 1 hour each and modified to meet the unique needs of each individual with PD. Caregivers will attend 4 separate educational sessions-lasting 30 minutes each--designed to provide them with the tools needed to reinforce and supplement the material presented in the cognitive-behavioral sessions. Duration of the study for participants is 15 weeks.

This is the first study to evaluate the impact of a cognitive-behavioral treatment for PD depression in a randomized controlled trial. Information gained from this study may be beneficial in treating depression in persons with PD.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson's Disease
  • Depression
Intervention  ICMJE Behavioral: cognitive-behavioral therapy
The therapy will consist of 10 weekly individual cognitive-behavioral treatment sessions, lasting 1 hour each and modified to meet the unique needs of each individual with PD.
Study Arms  ICMJE
  • Active Comparator: 1
    cognitive-behavioral therapy
    Intervention: Behavioral: cognitive-behavioral therapy
  • No Intervention: 2
    standard medical care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2014)
80
Original Enrollment  ICMJE
 (submitted: April 20, 2007)
160
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Persons with PD Inclusion Criteria:

  • Confirmed diagnosis of PD with no significant motor fluctuations or dementia.
  • Major Depression, Dysthymia, or Depression NOS (Clinically significant depression not otherwise specified).
  • 35-85 years old.
  • Willingness to ask a family member or friend, with whom the patient has regular contact, to be involved in treatment.
  • Patients will be allowed to remain on antidepressant medications that have been stabilized (e.g., no dose changes) for at least 6 weeks prior to screening provided that they do not have plans to change these medications while in the study.
  • Patients will be allowed to remain on sedative-hypnotics or anxiolytics that have been stabilized for at least 4 weeks prior to screening. Patients who are taking these medications at screening and qualify for participation will be asked to remain on a stable course of these medications throughout the trial.
  • Taking a stable dose of dopaminergic replacement therapy for at least one month

Persons with PD Exclusion Criteria:

  • DSM-IV criteria for a psychotic disorder, bipolar disorder, organic brain syndrome, or psychoactive substance dependence or abuse (Nicotine or caffeine dependence is allowed). Other psychiatric co-morbidity is not exclusionary as long as the depressive disorder is primary.
  • Active suicidal ideation.
  • An unstable major medical condition that would interfere with the study.
  • Plans to engage in additional psychotherapy during the study (PD support group is ok).
  • A diagnosis of dementia, defined as above.
  • Significant motor fluctuations, defined as above; mild end of dose wearing off is allowed.
  • Patients unwilling or unable to maintain a stable dose of dopaminergic replacement therapy during the trial.
  • Use of mood-stabilizers or antipsychotic medication.

Caregiver Inclusion Criteria:

  • Ages 25 to 85
  • Daily contact with a friend, family member, or spouse with depression and PD *MMSE > 26 [Mini Mental Status Exam score of greater than 26 (i.e., no signs of significant memory impairment)].

Caregiver Exclusion Criteria:

  • Active suicidal ideation
  • An unstable major medical or psychiatric condition
  • Evidence upon clinical interview of substance abuse/dependence
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00464464
Other Study ID Numbers  ICMJE 0220060139
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Roseanne D Dobkin, PhD Associate Professor of Psychiatry Rutgers-Robert Wood Johnson Medical School
Study Chair: Matthew Menza, MD Professor and Chair, Department of Psychiatry, Rutgers- Robert Wood Johnson Medical School (Primary Mentor)
PRS Account Rutgers, The State University of New Jersey
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP