Trial Outcomes & Findings for Telehealth Cognitive Behavioral Therapy for Depression in Parkinson's Disease (PD) (NCT NCT02475954)

Last Updated: 2023-07-28

Results Overview

This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms, with higher scores indicating greater depression. Hamilton Depression Rating Scale (HAMD) Score Min:0 and Max: 52. Higher scores mean a worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

174 participants

Primary outcome timeframe

10 weeks (endpoint) and 6 months post-treatment

Results posted on

2023-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	TH-CBT + Standard Care Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-Home. Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).	Standard Care VA standard care depression in Parkinson's Disease (PD) Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable anti-depressant medications, established psychotherapy, clinical monitoring).
Overall Study STARTED	87	87
Overall Study COMPLETED	73	75
Overall Study NOT COMPLETED	14	12

Reasons for withdrawal

Reasons for withdrawal
Measure	TH-CBT + Standard Care Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-Home. Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).	Standard Care VA standard care depression in Parkinson's Disease (PD) Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable anti-depressant medications, established psychotherapy, clinical monitoring).
Overall Study Withdrawal by Subject	2	2
Overall Study Lost to Follow-up	11	9
Overall Study Death	1	1

Baseline Characteristics

One person had missing data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TH-CBT + Standard Care n=87 Participants Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-Home. Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).	Standard Care n=87 Participants VA standard care depression in Parkinson's Disease (PD) Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).	Total n=174 Participants Total of all reporting groups
Age, Continuous	67.27 years STANDARD_DEVIATION 7.79 • n=87 Participants	66.42 years STANDARD_DEVIATION 9.51 • n=87 Participants	66.84 years STANDARD_DEVIATION 8.65 • n=174 Participants
Sex: Female, Male Female	41 Participants n=87 Participants • One person had missing data.	39 Participants n=86 Participants • One person had missing data.	80 Participants n=173 Participants • One person had missing data.
Sex: Female, Male Male	46 Participants n=87 Participants • One person had missing data.	47 Participants n=86 Participants • One person had missing data.	93 Participants n=173 Participants • One person had missing data.
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=82 Participants • Missing data	4 Participants n=86 Participants • Missing data	11 Participants n=168 Participants • Missing data
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=82 Participants • Missing data	82 Participants n=86 Participants • Missing data	157 Participants n=168 Participants • Missing data
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=82 Participants • Missing data	0 Participants n=86 Participants • Missing data	0 Participants n=168 Participants • Missing data
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=84 Participants • Missing data	1 Participants n=85 Participants • Missing data	1 Participants n=169 Participants • Missing data
Race (NIH/OMB) Asian	2 Participants n=84 Participants • Missing data	0 Participants n=85 Participants • Missing data	2 Participants n=169 Participants • Missing data
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=84 Participants • Missing data	0 Participants n=85 Participants • Missing data	0 Participants n=169 Participants • Missing data
Race (NIH/OMB) Black or African American	6 Participants n=84 Participants • Missing data	4 Participants n=85 Participants • Missing data	10 Participants n=169 Participants • Missing data
Race (NIH/OMB) White	75 Participants n=84 Participants • Missing data	80 Participants n=85 Participants • Missing data	155 Participants n=169 Participants • Missing data
Race (NIH/OMB) More than one race	1 Participants n=84 Participants • Missing data	0 Participants n=85 Participants • Missing data	1 Participants n=169 Participants • Missing data
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=84 Participants • Missing data	0 Participants n=85 Participants • Missing data	0 Participants n=169 Participants • Missing data
Hamilton Depression Rating Scale	21.60 units on a scale STANDARD_DEVIATION 4.30 • n=45 Participants • Hamilton Depression Rating Scale was only given to veterans not care partners.	22.49 units on a scale STANDARD_DEVIATION 3.85 • n=45 Participants • Hamilton Depression Rating Scale was only given to veterans not care partners.	22.04 units on a scale STANDARD_DEVIATION 4.08 • n=90 Participants • Hamilton Depression Rating Scale was only given to veterans not care partners.
Hamilton Anxiety Rating Scale	23.49 units on a scale STANDARD_DEVIATION 4.57 • n=45 Participants • Hamilton Anxiety Rating Scale was only given to veterans, not care partners.	24.16 units on a scale STANDARD_DEVIATION 4.14 • n=45 Participants • Hamilton Anxiety Rating Scale was only given to veterans, not care partners.	23.82 units on a scale STANDARD_DEVIATION 4.35 • n=90 Participants • Hamilton Anxiety Rating Scale was only given to veterans, not care partners.
Montreal Cognitive Assessment	25.17 units on a scale STANDARD_DEVIATION 2.72 • n=45 Participants • This assessment was only given to veterans not care partners.	25.00 units on a scale STANDARD_DEVIATION 2.43 • n=45 Participants • This assessment was only given to veterans not care partners.	25.08 units on a scale STANDARD_DEVIATION 2.57 • n=90 Participants • This assessment was only given to veterans not care partners.

PRIMARY outcome

Timeframe: 10 weeks (endpoint) and 6 months post-treatment

Population: This assessment was only given to veterans not care partners.

Outcome measures

Outcome measures
Measure	TH-CBT + Standard Care n=45 Participants Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-home. Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).	Standard Care n=45 Participants VA standard care depression in Parkinson's Disease (PD) Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).
Hamilton Depression Rating Scale 10 weeks (endpoint)	16.46 score on a scale Standard Deviation 5.18	21.37 score on a scale Standard Deviation 5.27
Hamilton Depression Rating Scale 6 months post-treatment	16.35 score on a scale Standard Deviation 4.97	20.70 score on a scale Standard Deviation 5.47

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks (endpoint) and 6 months post-treatment

Population: This assessment was only given to care partners not veterans. Some care partners did not complete the Family Empowerment Scale at 6-months post treatment.

The Family Empowerment scale measures the degree to which caregivers feel empowered to help care for their Veteran. To obtain a score for each area, sum the item responses where "Not at all" is scoring as 1, "Mostly not true" is scored as 2, "Somewhat true" is scored as 3, "Mostly true" is scored as 4, and "Very true" is scored as 5 to produce a score ranging from 12-60. The items are scored in the same direction, i.e., no item scores are reversed, and a higher score indicates relatively more empowerment in each respective area. Higher scores mean a better outcome.

Outcome measures

Outcome measures
Measure	TH-CBT + Standard Care n=44 Participants Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-home. Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).	Standard Care n=43 Participants VA standard care depression in Parkinson's Disease (PD) Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).
Family Empowerment Scale 10 weeks (endpoint)	49.82 score on a scale Standard Deviation 6.20	44.06 score on a scale Standard Deviation 9.12
Family Empowerment Scale 6 months post-treatment	49.66 score on a scale Standard Deviation 7.47	45.31 score on a scale Standard Deviation 7.04

Adverse Events

TH-CBT + Standard Care

Serious events: 9 serious events

Other events: 9 other events

Deaths: 1 deaths

Standard Care

Serious events: 12 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	TH-CBT + Standard Care n=87 participants at risk Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-Home. Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).	Standard Care n=87 participants at risk VA standard care depression in Parkinson's Disease (PD) Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).
Cardiac disorders Cardiac related	3.4% 3/87 • Number of events 3 • 2.5 years	1.1% 1/87 • Number of events 1 • 2.5 years
Endocrine disorders Endocrine related	1.1% 1/87 • Number of events 1 • 2.5 years	0.00% 0/87 • 2.5 years
Gastrointestinal disorders GI related	0.00% 0/87 • 2.5 years	2.3% 2/87 • Number of events 2 • 2.5 years
General disorders General disorders related	0.00% 0/87 • 2.5 years	1.1% 1/87 • Number of events 1 • 2.5 years
Infections and infestations Infection related	0.00% 0/87 • 2.5 years	2.3% 2/87 • Number of events 2 • 2.5 years
Nervous system disorders Nervous system related	4.6% 4/87 • Number of events 4 • 2.5 years	1.1% 1/87 • Number of events 1 • 2.5 years
Renal and urinary disorders Renal related	1.1% 1/87 • Number of events 1 • 2.5 years	0.00% 0/87 • 2.5 years
Musculoskeletal and connective tissue disorders Muscle related	0.00% 0/87 • 2.5 years	5.7% 5/87 • Number of events 5 • 2.5 years

Other adverse events

Other adverse events
Measure	TH-CBT + Standard Care n=87 participants at risk Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). TH-CBT: The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-Home. Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).	Standard Care n=87 participants at risk VA standard care depression in Parkinson's Disease (PD) Standard Care: Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable antidepressant medication, established psychotherapy, clinical monitoring).
Musculoskeletal and connective tissue disorders Muscle related	1.1% 1/87 • Number of events 1 • 2.5 years	4.6% 4/87 • Number of events 4 • 2.5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer related	3.4% 3/87 • Number of events 3 • 2.5 years	0.00% 0/87 • 2.5 years
Nervous system disorders Nervous system related	4.6% 4/87 • Number of events 4 • 2.5 years	2.3% 2/87 • Number of events 2 • 2.5 years
Cardiac disorders Cardiac related	0.00% 0/87 • 2.5 years	1.1% 1/87 • Number of events 1 • 2.5 years
Gastrointestinal disorders GI related	0.00% 0/87 • 2.5 years	1.1% 1/87 • Number of events 1 • 2.5 years
Renal and urinary disorders Urinary related	0.00% 0/87 • 2.5 years	1.1% 1/87 • Number of events 1 • 2.5 years
General disorders General disorders related	1.1% 1/87 • Number of events 1 • 2.5 years	0.00% 0/87 • 2.5 years

Additional Information

Roseanne D. 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