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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Depression Behavioral: cognitive-behavioral therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Depression in Parkinson's Disease: A New Method
Study Start Date : April 2007
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
cognitive-behavioral therapy
 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.
No Intervention: 2
standard medical care


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464464


Locations
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United States, New Jersey
Rutgers, Robert Wood Johnson Medical School, 675 Hoes Lane, Room D-317
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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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)
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00464464     History of Changes
Other Study ID Numbers: 0220060139
First Posted: April 23, 2007    Key Record Dates
Results First Posted: November 5, 2014
Last Update Posted: November 5, 2014
Last Verified: November 2014
Keywords provided by Rutgers, The State University of New Jersey:
Parkinson's disease
PD
depression
cognitive-behavioral therapy
social support
Additional relevant MeSH terms:
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Parkinson Disease
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
 Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases