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Coping With Depression in Parkinson's Disease

Primary Purpose

Parkinson's Disease, Depression

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

cognitive-behavioral therapy

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, PD, depression, cognitive-behavioral therapy, social support

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rutgers, Robert Wood Johnson Medical School, 675 Hoes Lane, Room D-317

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

cognitive-behavioral therapy

standard medical care

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00464464

First Posted

April 20, 2007

Last Updated

November 4, 2014

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT00464464

Brief Title

Coping With Depression in Parkinson's Disease

Official Title

Treating Depression in Parkinson's Disease: A New Method

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease, Depression

Keywords

Parkinson's disease, PD, depression, cognitive-behavioral therapy, social support

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

cognitive-behavioral therapy

Arm Title

Arm Type

No Intervention

Arm Description

standard medical care

Intervention Type

Behavioral

Intervention Name(s)

cognitive-behavioral therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hamilton Depression Rating Scale: Baseline

Description

Time Frame

0 weeks

Title

Hamilton Depression Rating Scale: Midpoint

Description

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.

Time Frame

5 weeks

Title

Hamilton Depression Rating Scale: Endpoint

Description

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.

Time Frame

10 weeks

Title

Hamilton Depression Rating Scale: Follow-Up Evaluation

Description

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.

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roseanne D Dobkin, PhD

Organizational Affiliation

Associate Professor of Psychiatry Rutgers-Robert Wood Johnson Medical School

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Matthew Menza, MD

Organizational Affiliation

Professor and Chair, Department of Psychiatry, Rutgers- Robert Wood Johnson Medical School (Primary Mentor)

Official's Role

Study Chair

Facility Information:

Facility Name

Rutgers, Robert Wood Johnson Medical School, 675 Hoes Lane, Room D-317

City

Piscataway

State/Province

New Jersey

ZIP/Postal Code

08854

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21676990

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.

Results Reference

result

PubMed Identifier

22409644

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.

Results Reference

result

PubMed Identifier

22228827

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.

Results Reference

result

PubMed Identifier

24275895

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.

Results Reference

result

PubMed Identifier

24763770

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.

Results Reference

result

PubMed Identifier

30714202

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.

Results Reference

derived

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Coping With Depression in Parkinson's Disease

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