Trial Outcomes & Findings for Coping With Depression in Parkinson's Disease (NCT NCT00464464)

Last Updated: 2014-11-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

0 weeks

Results posted on

2014-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	41	39
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coping With Depression in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive-Behavioral Therapy Condition n=41 Participants 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.	Standard Medical Care Condition n=39 Participants 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 n=80 Participants Total of all reporting groups
Age, Continuous	63.73 years STANDARD_DEVIATION 9.89 • n=5 Participants	65.44 years STANDARD_DEVIATION 11.23 • n=7 Participants	64.56 years STANDARD_DEVIATION 10.53 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	38 participants n=5 Participants	36 participants n=7 Participants	74 participants n=5 Participants
Race/Ethnicity, Customized African American	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	39 participants n=5 Participants	38 participants n=7 Participants	77 participants n=5 Participants
Parkinson's disease duration	6.53 years STANDARD_DEVIATION 5.53 • n=5 Participants	6.13 years STANDARD_DEVIATION 5.56 • n=7 Participants	6.34 years STANDARD_DEVIATION 5.51 • n=5 Participants
Dementia Rating Scale score	139.44 units on a scale STANDARD_DEVIATION 3.8 • n=5 Participants	136.97 units on a scale STANDARD_DEVIATION 5.5 • n=7 Participants	138.24 units on a scale STANDARD_DEVIATION 4.9 • n=5 Participants

PRIMARY outcome

Timeframe: 0 weeks

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Therapy Condition n=41 Participants 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.	Standard Medical Care Condition n=39 Participants 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.
Hamilton Depression Rating Scale: Baseline	20.93 units on a scale Standard Deviation 4.56	19.38 units on a scale Standard Deviation 4.56

PRIMARY outcome

Timeframe: 5 weeks

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.

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Therapy Condition n=41 Participants 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.	Standard Medical Care Condition n=39 Participants 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.
Hamilton Depression Rating Scale: Midpoint	14.92 units on a scale Standard Deviation 4.73	19.71 units on a scale Standard Deviation 4.56

PRIMARY outcome

Timeframe: 10 weeks

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.

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Therapy Condition n=41 Participants 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.	Standard Medical Care Condition n=39 Participants 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.
Hamilton Depression Rating Scale: Endpoint	13.58 units on a scale Standard Deviation 4.72	19.33 units on a scale Standard Deviation 4.55

PRIMARY outcome

Timeframe: 14 weeks

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.

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Therapy Condition n=41 Participants 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.	Standard Medical Care Condition n=39 Participants 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.
Hamilton Depression Rating Scale: Follow-Up Evaluation	14.52 units on a scale Standard Deviation 4.75	19.31 units on a scale Standard Deviation 4.63

Adverse Events

Cognitive-Behavioral Therapy Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Medical Care Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Roseanne Dobkin

Rutgers- Robert Wood Johnson Medical School

Phone: 732-235-4051

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place