Trial Outcomes & Findings for Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression (NCT NCT04487730)
NCT ID: NCT04487730
Last Updated: 2025-06-03
Results Overview
Calculated from fMRI scan. Validation of target engagement (resting state functional connectivity (rsFC) within the right hemisphere orbital prefrontal cortex (OFC), specifically between the lateral and medial regions of the OFC).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)
Results posted on
2025-06-03
Participant Flow
Participant milestones
| Measure |
"Engage & Connect" Psychotherapy
"Engage \& Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.
"Engage \& Connect" Psychotherapy: 9-weeks of weekly psychotherapy sessions focused on social reward exposure
|
Symptom Review and Psychoeducation (SRP)
In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.
Symptom Review and Psychoeducation (SRP): 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
|
Overall Study
COMPLETED
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
"Engage & Connect" Psychotherapy
"Engage \& Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.
"Engage \& Connect" Psychotherapy: 9-weeks of weekly psychotherapy sessions focused on social reward exposure
|
Symptom Review and Psychoeducation (SRP)
In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.
Symptom Review and Psychoeducation (SRP): 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression
Baseline characteristics by cohort
| Measure |
"Engage & Connect" Psychotherapy
n=31 Participants
"Engage \& Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.
"Engage \& Connect" Psychotherapy: 9-weeks of weekly psychotherapy sessions focused on social reward exposure
|
Symptom Review and Psychoeducation (SRP)
n=33 Participants
In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.
Symptom Review and Psychoeducation (SRP): 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)Population: Participants were excluded from analysis in the event no data were collected at baseline due to participant withdrawal, if the participants were clinically excluded during the study, technical issues with MRI data, or lost to follow-up.
Calculated from fMRI scan. Validation of target engagement (resting state functional connectivity (rsFC) within the right hemisphere orbital prefrontal cortex (OFC), specifically between the lateral and medial regions of the OFC).
Outcome measures
| Measure |
"Engage & Connect" Psychotherapy
n=24 Participants
"Engage \& Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.
"Engage \& Connect" Psychotherapy: 9-weeks of weekly psychotherapy sessions focused on social reward exposure
|
Symptom Review and Psychoeducation (SRP)
n=23 Participants
In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.
Symptom Review and Psychoeducation (SRP): 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
|
|---|---|---|
|
Change in Resting State fMRI Connectivity of the Positive Valence System
Baseline
|
0.18 rsFC correlation coefficient
Standard Error 0.03
|
0.18 rsFC correlation coefficient
Standard Error 0.02
|
|
Change in Resting State fMRI Connectivity of the Positive Valence System
Week 5
|
0.24 rsFC correlation coefficient
Standard Error 0.02
|
0.29 rsFC correlation coefficient
Standard Error 0.02
|
|
Change in Resting State fMRI Connectivity of the Positive Valence System
Week 9
|
0.25 rsFC correlation coefficient
Standard Error 0.03
|
0.24 rsFC correlation coefficient
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)Population: Participants were excluded from analysis in the event no data were collected at baseline due to participant withdrawal, if the participants were clinically excluded during the study, or lost to follow-up.
10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression).
Outcome measures
| Measure |
"Engage & Connect" Psychotherapy
n=29 Participants
"Engage \& Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.
"Engage \& Connect" Psychotherapy: 9-weeks of weekly psychotherapy sessions focused on social reward exposure
|
Symptom Review and Psychoeducation (SRP)
n=31 Participants
In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.
Symptom Review and Psychoeducation (SRP): 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
|
|---|---|---|
|
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Baseline
|
23.66 score on a scale
Standard Deviation 4.62
|
24.81 score on a scale
Standard Deviation 3.39
|
|
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Mid-treatment (Week 5)
|
13.82 score on a scale
Standard Deviation 7.56
|
18.62 score on a scale
Standard Deviation 7.03
|
|
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Post Treatment (Week 9)
|
11.86 score on a scale
Standard Deviation 8.97
|
14.66 score on a scale
Standard Deviation 8.89
|
SECONDARY outcome
Timeframe: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)Population: Participants were excluded from analysis in the event no data were collected at baseline due to participant withdrawal, if the participants were clinically excluded during the study, lost to follow-up, or did not complete the BADS.
25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).
Outcome measures
| Measure |
"Engage & Connect" Psychotherapy
n=29 Participants
"Engage \& Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.
"Engage \& Connect" Psychotherapy: 9-weeks of weekly psychotherapy sessions focused on social reward exposure
|
Symptom Review and Psychoeducation (SRP)
n=31 Participants
In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.
Symptom Review and Psychoeducation (SRP): 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
|
|---|---|---|
|
Change in Behavioral Activation for Depression Scale (BADS)
Post Treatment (Week 9)
|
98.00 score on a scale
Standard Deviation 30.54
|
93.86 score on a scale
Standard Deviation 25.28
|
|
Change in Behavioral Activation for Depression Scale (BADS)
Baseline
|
71.24 score on a scale
Standard Deviation 21.36
|
70.00 score on a scale
Standard Deviation 18.40
|
|
Change in Behavioral Activation for Depression Scale (BADS)
Mid-treatment (Week 5)
|
95.21 score on a scale
Standard Deviation 28.84
|
88.21 score on a scale
Standard Deviation 20.73
|
Adverse Events
"Engage & Connect" Psychotherapy
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Symptom Review and Psychoeducation (SRP)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
"Engage & Connect" Psychotherapy
n=31 participants at risk
"Engage \& Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.
"Engage \& Connect" Psychotherapy: 9-weeks of weekly psychotherapy sessions focused on social reward exposure
|
Symptom Review and Psychoeducation (SRP)
n=33 participants at risk
In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.
Symptom Review and Psychoeducation (SRP): 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Wearable device (watch) irritation
|
9.7%
3/31 • Number of events 3 • 9 weeks
|
3.0%
1/33 • Number of events 1 • 9 weeks
|
|
General disorders
Hospital Visits (unrelated to research)
|
12.9%
4/31 • Number of events 4 • 9 weeks
|
9.1%
3/33 • Number of events 4 • 9 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place