Trial Outcomes & Findings for Reward Function and Therapy for Late-Life Depression (NCT NCT03688139)
NCT ID: NCT03688139
Last Updated: 2024-11-14
Results Overview
The late positive potential (LPP) is an electroencephalographic (EEG)-derived measure of emotional engagement with positively valanced images.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Change from baseline to week 9
Results posted on
2024-11-14
Participant Flow
Participants were recruited through community referrals, physical ads posted in locations frequented by older adults, a depression screening hotline maintained by the Weill Cornell Institute of Geriatric Psychiatry, and via ads posted on social media. The first participant was enrolled on 3/14/2019, and the last participant was enrolled on 9/26/2023.
Participant milestones
| Measure |
Engage Therapy
Participants receive Engage therapy for 9 weeks.
Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.
|
Supportive Therapy
Participants receive supportive therapy for 9 weeks.
Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
COMPLETED
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Engage Therapy
Participants receive Engage therapy for 9 weeks.
Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.
|
Supportive Therapy
Participants receive supportive therapy for 9 weeks.
Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
Baseline characteristics by cohort
| Measure |
Engage Therapy
n=32 Participants
Participants receive Engage therapy for 9 weeks.
Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.
|
Supportive Therapy
n=33 Participants
Participants receive supportive therapy for 9 weeks.
Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.79 years
STANDARD_DEVIATION 6.34 • n=32 Participants
|
72.75 years
STANDARD_DEVIATION 7.64 • n=33 Participants
|
70.31 years
STANDARD_DEVIATION 7.41 • n=65 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=32 Participants
|
24 Participants
n=33 Participants
|
49 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=32 Participants
|
9 Participants
n=33 Participants
|
16 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=32 Participants
|
33 Participants
n=33 Participants
|
64 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=32 Participants
|
1 Participants
n=33 Participants
|
2 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=32 Participants
|
3 Participants
n=33 Participants
|
7 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=32 Participants
|
29 Participants
n=33 Participants
|
56 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=32 Participants
|
33 Participants
n=33 Participants
|
65 Participants
n=65 Participants
|
|
Late Positive Potential
|
4.84 microvolts
STANDARD_DEVIATION 3.13 • n=29 Participants • Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
|
6.78 microvolts
STANDARD_DEVIATION 4.87 • n=32 Participants • Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
|
5.86 microvolts
STANDARD_DEVIATION 4.22 • n=61 Participants • Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
|
|
Reward Positivity
|
2.15 microvolts
STANDARD_DEVIATION 2.37 • n=28 Participants • Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
|
2.26 microvolts
STANDARD_DEVIATION 3.80 • n=29 Participants • Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
|
2.21 microvolts
STANDARD_DEVIATION 3.15 • n=57 Participants • Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
|
|
P1
|
1.92 microvolts
STANDARD_DEVIATION 3.80 • n=29 Participants • Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
|
2.41 microvolts
STANDARD_DEVIATION 3.09 • n=32 Participants • Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
|
2.18 microvolts
STANDARD_DEVIATION 3.42 • n=61 Participants • Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
|
|
Behavioral Activation
|
82.72 units on a scale
STANDARD_DEVIATION 21.52 • n=29 Participants • Two participants dropped out before baseline and some data points are missing due to missed study assessments.
|
77.75 units on a scale
STANDARD_DEVIATION 15.77 • n=32 Participants • Two participants dropped out before baseline and some data points are missing due to missed study assessments.
|
80.11 units on a scale
STANDARD_DEVIATION 18.73 • n=61 Participants • Two participants dropped out before baseline and some data points are missing due to missed study assessments.
|
|
Anhedonia
|
30.30 units on a scale
STANDARD_DEVIATION 6.91 • n=30 Participants • Two participants dropped out before baseline and some data points are missing due to missed study assessments.
|
32.31 units on a scale
STANDARD_DEVIATION 6.35 • n=32 Participants • Two participants dropped out before baseline and some data points are missing due to missed study assessments.
|
31.34 units on a scale
STANDARD_DEVIATION 6.65 • n=62 Participants • Two participants dropped out before baseline and some data points are missing due to missed study assessments.
|
PRIMARY outcome
Timeframe: Change from baseline to week 9Population: Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
The late positive potential (LPP) is an electroencephalographic (EEG)-derived measure of emotional engagement with positively valanced images.
Outcome measures
| Measure |
Engage Therapy
n=25 Participants
Participants receive Engage therapy for 9 weeks.
Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.
|
Supportive Therapy
n=23 Participants
Participants receive supportive therapy for 9 weeks.
Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.
|
|---|---|---|
|
Change in Late Positive Potential to Rewarding Stimuli
|
0.80 microvolts
Standard Deviation 3.24
|
0.07 microvolts
Standard Deviation 3.25
|
PRIMARY outcome
Timeframe: Change from baseline to week 9Population: Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
The reward positivity (RewP) is an electroencephalographic (EEG)-derived response to rewarding feedback from a guessing task.
Outcome measures
| Measure |
Engage Therapy
n=24 Participants
Participants receive Engage therapy for 9 weeks.
Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.
|
Supportive Therapy
n=22 Participants
Participants receive supportive therapy for 9 weeks.
Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.
|
|---|---|---|
|
Change in the Reward Positivity
|
-0.46 microvolts
Standard Deviation 3.66
|
-0.60 microvolts
Standard Deviation 4.85
|
PRIMARY outcome
Timeframe: Change from baseline to week 9Population: Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
The P1 is an electroencephalographic (EEG)-derived measure of early visual attention that is elicited by visual stimuli.
Outcome measures
| Measure |
Engage Therapy
n=25 Participants
Participants receive Engage therapy for 9 weeks.
Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.
|
Supportive Therapy
n=23 Participants
Participants receive supportive therapy for 9 weeks.
Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.
|
|---|---|---|
|
Change in P1
|
-0.24 microvolts
Standard Deviation 1.39
|
0.43 microvolts
Standard Deviation 1.61
|
PRIMARY outcome
Timeframe: Change from baseline to week 9Population: Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
Behavioral activation will be measured using the Behavioral Activation for Depression Scale (BADS), a 25-item measure of behaviors targeted in behavioral activation therapies such as Engage. Scores range from 0 to 150, where higher scores on this measure indicate more participation in activities and social interactions, and lower scores indicate more social isolation, rumination, and avoidance of activities.
Outcome measures
| Measure |
Engage Therapy
n=26 Participants
Participants receive Engage therapy for 9 weeks.
Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.
|
Supportive Therapy
n=28 Participants
Participants receive supportive therapy for 9 weeks.
Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.
|
|---|---|---|
|
Change in Behavioral Activation
|
12.88 units on a scale
Standard Deviation 14.64
|
18.93 units on a scale
Standard Deviation 23.51
|
SECONDARY outcome
Timeframe: Change from baseline to week 9Population: Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments.
Anhedonia will be measured by the clinician-rated Snaith-Hamilton Pleasure Scale (SHAPS-C). The SHAPS-C measures pleasure and enjoyment experienced in response to a variety of situations. Scores range from 14 to 56, where higher scores indicate greater severity of anhedonia and lower scores indicate lower severity of anhedonia.
Outcome measures
| Measure |
Engage Therapy
n=27 Participants
Participants receive Engage therapy for 9 weeks.
Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.
|
Supportive Therapy
n=28 Participants
Participants receive supportive therapy for 9 weeks.
Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.
|
|---|---|---|
|
Change in Anhedonia
|
-3.37 units on a scale
Standard Deviation 5.96
|
-2.07 units on a scale
Standard Deviation 6.13
|
Adverse Events
Engage Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Supportive Therapy
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Engage Therapy
n=32 participants at risk
Participants receive Engage therapy for 9 weeks.
Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.
|
Supportive Therapy
n=33 participants at risk
Participants receive supportive therapy for 9 weeks.
Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.
|
|---|---|---|
|
General disorders
Fall resulting in injury
|
0.00%
0/32 • Baseline to week 9 of study participation
|
9.1%
3/33 • Baseline to week 9 of study participation
|
|
Musculoskeletal and connective tissue disorders
Leg pain requiring surgery
|
0.00%
0/32 • Baseline to week 9 of study participation
|
3.0%
1/33 • Baseline to week 9 of study participation
|
|
Gastrointestinal disorders
Abdominal and thoracic pain requiring endoscopy
|
3.1%
1/32 • Baseline to week 9 of study participation
|
0.00%
0/33 • Baseline to week 9 of study participation
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/32 • Baseline to week 9 of study participation
|
3.0%
1/33 • Baseline to week 9 of study participation
|
|
Musculoskeletal and connective tissue disorders
Fractured pelvis
|
0.00%
0/32 • Baseline to week 9 of study participation
|
3.0%
1/33 • Baseline to week 9 of study participation
|
|
General disorders
Hair loss at EEG electrode site
|
0.00%
0/32 • Baseline to week 9 of study participation
|
3.0%
1/33 • Baseline to week 9 of study participation
|
Additional Information
Dr. Jennifer N. Bress
Weill Medical College of Cornell University
Phone: 914-997-8683
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place