Clinical trial NCT00464464: Coping With Depression in Parkinson's Disease
Official title: Treating Depression in Parkinson's Disease: A New Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Depression
Keywords: Parkinson's disease
PD
depression
cognitive-behavioral therapy
social support
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2007-04-23
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Depression Rating Scale: Baseline
timeFrame: 0 weeks
measure: Hamilton Depression Rating Scale: Midpoint
timeFrame: 5 weeks
measure: Hamilton Depression Rating Scale: Endpoint
timeFrame: 10 weeks
measure: Hamilton Depression Rating Scale: Follow-Up Evaluation
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers, Robert Wood Johnson Medical School, 675 Hoes Lane, Room D-317
state: New Jersey
Study officials:
affiliation: Associate Professor of Psychiatry Rutgers-Robert Wood Johnson Medical School
name: Roseanne D Dobkin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor and Chair, Department of Psychiatry, Rutgers- Robert Wood Johnson Medical School (Primary Mentor)
name: Matthew Menza, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Dobkin RD, Troster 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.
citation: 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.
citation: 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.