Coping With Depression in Parkinson's Disease

Depression Clinical Trial

Official title:

Treating Depression in Parkinson's Disease: A New Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464464
• Other study ID #: 0220060139
• Status: Completed
• Phase: N/A
• First received: April 20, 2007
• Last updated: November 4, 2014
• Start date: April 2007
• Est. completion date: March 2013

Study information

• Verified date: November 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Parkinson Disease
• Parkinson's Disease

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.

Locations

Country	Name	City	State
United States	Rutgers, Robert Wood Johnson Medical School, 675 Hoes Lane, Room D-317	Piscataway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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.2011.10111 — View 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. — View 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 M — View Citation

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.neuropsyc — View 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.1303006 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale: Baseline	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.	0 weeks	No
Primary	Hamilton Depression Rating Scale: Midpoint	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.	5 weeks	No
Primary	Hamilton Depression Rating Scale: Endpoint	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.	10 weeks	No
Primary	Hamilton Depression Rating Scale: Follow-Up Evaluation	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.	14 weeks	No