Coping With Depression in Parkinson's Disease

• 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: Rutgers, The State University of New Jersey
• 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: April 20, 2007
• First Posted Date: April 23, 2007
• Results First Submitted Date: March 10, 2014
• Results First Posted Date: November 5, 2014
• Last Update Posted Date: November 5, 2014
• Study Start Date: April 2007
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: April 20, 2007): Hamilton Rating Scale for Depression.
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (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: Coping With Depression in Parkinson's Disease
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Parkinson's Disease
• Depression

Intervention

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

• Active Comparator: 1
  cognitive-behavioral therapy
  Intervention: Behavioral: cognitive-behavioral therapy
• No Intervention: 2
  standard medical care

Publications *

• Dobkin RD, Menza M, Allen LA, Gara MA, Mark MH, Tiu J, Bienfait KL, Friedman J. Cognitive-behavioral therapy for depression in Parkinson's disease: a randomized, controlled trial. Am J Psychiatry. 2011 Oct;168(10):1066-74. doi: 10.1176/appi.ajp.2011.10111669. Epub 2011 Jun 15.
• Dobkin RD, Rubino JT, Allen LA, Friedman J, Gara MA, Mark MH, Menza M. Predictors of treatment response to cognitive-behavioral therapy for depression in Parkinson's disease. J Consult Clin Psychol. 2012 Aug;80(4):694-9. doi: 10.1037/a0027695. Epub 2012 Mar 12.
• Dobkin RD, Menza M, Allen LA, Tiu J, Friedman J, Bienfait KL, Gara MA, Mark MH. Telephone-based cognitive-behavioral therapy for depression in Parkinson disease. J Geriatr Psychiatry Neurol. 2011 Dec;24(4):206-14. doi: 10.1177/0891988711422529.
• Dobkin RD, Tröster AI, Rubino JT, Allen LA, Gara MA, Mark MH, Menza M. Neuropsychological outcomes after psychosocial intervention for depression in Parkinson's disease. J Neuropsychiatry Clin Neurosci. 2014 Winter;26(1):57-63. doi: 10.1176/appi.neuropsych.12120381.
• Dobkin RD. The relationship between telephone-administered cognitive-behavioral therapy for depression and neuropsychological functioning in Parkinson's disease. J Neuropsychiatry Clin Neurosci. 2014 Apr 1;26(2):E10-1. doi: 10.1176/appi.neuropsych.13030065.
• Dobkin RD, Mann SL, Interian A, Gara MA, Menza M. Cognitive behavioral therapy improves diverse profiles of depressive symptoms in Parkinson's disease. Int J Geriatr Psychiatry. 2019 May;34(5):722-729. doi: 10.1002/gps.5077. Epub 2019 Mar 4.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 4, 2014): 80
• Original Enrollment (submitted: April 20, 2007): 160
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00464464
• Other Study ID Numbers: 0220060139
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Rutgers, The State University of New Jersey
• Study Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• 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