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Coping With Depression in Parkinson's Disease

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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:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Parkinson's Disease
Depression
Intervention Behavioral: cognitive-behavioral therapy
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive-Behavioral Therapy Condition Standard Medical Care Condition
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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.

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.
Period Title: Overall Study
Started 41 39
Completed 36 36
Not Completed 5 3
Arm/Group Title Cognitive-Behavioral Therapy Condition Standard Medical Care Condition Total
Hide Arm/Group Description

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.

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. Total of all reporting groups
Overall Number of Baseline Participants 41 39 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 39 participants 80 participants
63.73  (9.89) 65.44  (11.23) 64.56  (10.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 39 participants 80 participants
Female
25
  61.0%
23
  59.0%
48
  60.0%
Male
16
  39.0%
16
  41.0%
32
  40.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 39 participants 80 participants
Caucasian 38 36 74
African American 0 1 1
Asian 3 1 4
Pacific Islander 0 1 1
Hispanic 2 1 3
Non-Hispanic 39 38 77
Parkinson's disease duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 39 participants 80 participants
6.53  (5.53) 6.13  (5.56) 6.34  (5.51)
Dementia Rating Scale score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 41 participants 39 participants 80 participants
139.44  (3.8) 136.97  (5.5) 138.24  (4.9)
[1]
Measure Description:

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.

1.Primary Outcome
Title Hamilton Depression Rating Scale: Baseline
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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.

Time Frame 0 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-Behavioral Therapy Condition Standard Medical Care Condition
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 41 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.93  (4.56) 19.38  (4.56)
2.Primary Outcome
Title Hamilton Depression Rating Scale: Midpoint
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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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-Behavioral Therapy Condition Standard Medical Care Condition
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 41 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.92  (4.73) 19.71  (4.56)
3.Primary Outcome
Title Hamilton Depression Rating Scale: Endpoint
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-Behavioral Therapy Condition Standard Medical Care Condition
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 41 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.58  (4.72) 19.33  (4.55)
4.Primary Outcome
Title Hamilton Depression Rating Scale: Follow-Up Evaluation
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-Behavioral Therapy Condition Standard Medical Care Condition
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 41 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.52  (4.75) 19.31  (4.63)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive-Behavioral Therapy Condition Standard Medical Care Condition
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Cognitive-Behavioral Therapy Condition Standard Medical Care Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cognitive-Behavioral Therapy Condition Standard Medical Care Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/39 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive-Behavioral Therapy Condition Standard Medical Care Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/39 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Roseanne Dobkin
Organization: Rutgers- Robert Wood Johnson Medical School
Phone: 732-235-4051
EMail: dobkinro@rutgers.edu
Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00464464    
Other Study ID Numbers: 0220060139
First Submitted: April 20, 2007
First Posted: April 23, 2007
Results First Submitted: March 10, 2014
Results First Posted: November 5, 2014
Last Update Posted: November 5, 2014