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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | cognitive-behavioral therapy |
|
| 2 | No Intervention | standard medical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive-behavioral therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
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Persons with PD Inclusion Criteria:
Persons with PD Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roseanne D Dobkin, PhD | Associate Professor of Psychiatry Rutgers-Robert Wood Johnson Medical School | Principal Investigator |
| Matthew Menza, MD | Professor and Chair, Department of Psychiatry, Rutgers- Robert Wood Johnson Medical School (Primary Mentor) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers, Robert Wood Johnson Medical School, 675 Hoes Lane, Room D-317 | Piscataway | New Jersey | 08854 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21676990 | Result | 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. | |
| 22409644 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive-Behavioral Therapy Condition | Participants in the "Cognitive-Behavioral Therapy" condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD. These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial. |
| FG001 | Standard Medical Care Condition | Participants in the "Standard Medical Care" condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive-Behavioral Therapy Condition | Participants in the "Cognitive-Behavioral Therapy" condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD. These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 0 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive-Behavioral Therapy Condition | Participants in the "Cognitive-Behavioral Therapy" condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD. These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roseanne Dobkin | Rutgers- Robert Wood Johnson Medical School | 732-235-4051 | dobkinro@rutgers.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 14 weeks |
| 22228827 | Result | 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. |
| 24275895 | Result | 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. |
| 24763770 | Result | 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. |
| 30714202 | Derived | 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. |
| BG001 | Standard Medical Care Condition | Participants in the "Standard Medical Care" condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Parkinson's disease duration | Mean | Standard Deviation | years |
|
| Dementia Rating Scale score | The Dementia Rating Scale - 2 (DRS-2) was used to assess severity of symptoms associated with dementia in study participants. The measure includes sub-scales addressing Attention (ATT), Initiation/Perseveration (I/P), Construction (CONST), Conceptualization (CONCEPT), and Memory (MEM). The total score (a sum of the five sub-scale scores) was used as the outcome measure value. Possible DRS total scores range from 0 to 144, with higher values representing more severe dementia symptomatology, and lower scores representing less severe dementia symptomatology. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Standard Medical Care Condition | Participants in the "Standard Medical Care" condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial. |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 5 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 10 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 14 weeks |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Standard Medical Care Condition | Participants in the "Standard Medical Care" condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial. | 0 | 39 | 0 | 39 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |