Trial Outcomes & Findings for Reaching and Engaging Depressed Senior Center Clients (NCT NCT04289298)
NCT ID: NCT04289298
Last Updated: 2023-08-23
Results Overview
Number of Virtual ENGAGE-A Participants who Attend Every Scheduled Therapy Session
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
9 Weeks
Results posted on
2023-08-23
Participant Flow
Participant milestones
| Measure |
Engage-A
Participants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding.
Engage-A: Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
|
Clinician Participants
Clinicians who provided the ENGAGE intervention and participated in data collection about their experience.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
4
|
|
Overall Study
COMPLETED
|
15
|
4
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
| Measure |
Engage-A
Participants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding.
Engage-A: Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
|
Clinician Participants
Clinicians who provided the ENGAGE intervention and participated in data collection about their experience.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
The total number of ENGAGE-A participants analyzed differs from the overall total because 4 participants had incomplete baseline data. Depression scores were not collected for clinicians, as this measure is only appropriate for participants who are experiencing symptoms of depression.
Baseline characteristics by cohort
| Measure |
Engage-A
n=22 Participants
Participants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding.
Engage-A: Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
|
Clinician Participants
n=4 Participants
Clinicians who provided the ENGAGE intervention and participated in data collection about their experience.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.68 years
STANDARD_DEVIATION 6.53 • n=22 Participants
|
48.5 years
STANDARD_DEVIATION 10.43 • n=4 Participants
|
66.68 years
STANDARD_DEVIATION 6.53 • n=26 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=22 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=22 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=22 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=22 Participants
|
2 Participants
n=4 Participants
|
21 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=22 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=22 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=22 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=22 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=22 Participants
|
4 participants
n=4 Participants
|
26 participants
n=26 Participants
|
|
Hamilton Psychiatric Rating Scale for Depression (HAM-D)
|
21.28 units on a scale
STANDARD_DEVIATION 5.60 • n=18 Participants • The total number of ENGAGE-A participants analyzed differs from the overall total because 4 participants had incomplete baseline data. Depression scores were not collected for clinicians, as this measure is only appropriate for participants who are experiencing symptoms of depression.
|
—
|
21.28 units on a scale
STANDARD_DEVIATION 5.60 • n=18 Participants • The total number of ENGAGE-A participants analyzed differs from the overall total because 4 participants had incomplete baseline data. Depression scores were not collected for clinicians, as this measure is only appropriate for participants who are experiencing symptoms of depression.
|
|
Behavioral Activation for Depression Scale (BADS)
Domain 1, Baseline
|
18.62 units on a scale
STANDARD_DEVIATION 10.22 • n=21 Participants • The number of ENGAGE-A participants analyzed for the baseline domains differs because two participants had incomplete responses for this questionnaire. The remaining rows differ due to participant withdrawal and loss to follow-up. Behavioral activation data were not collected for clinicians, as this measure is only appropriate for participants experiencing depressive symptoms.
|
—
|
18.62 units on a scale
STANDARD_DEVIATION 10.22 • n=21 Participants • The number of ENGAGE-A participants analyzed for the baseline domains differs because two participants had incomplete responses for this questionnaire. The remaining rows differ due to participant withdrawal and loss to follow-up. Behavioral activation data were not collected for clinicians, as this measure is only appropriate for participants experiencing depressive symptoms.
|
|
Behavioral Activation for Depression Scale (BADS)
Domain 2, Baseline
|
22.50 units on a scale
STANDARD_DEVIATION 8.61 • n=20 Participants • The number of ENGAGE-A participants analyzed for the baseline domains differs because two participants had incomplete responses for this questionnaire. The remaining rows differ due to participant withdrawal and loss to follow-up. Behavioral activation data were not collected for clinicians, as this measure is only appropriate for participants experiencing depressive symptoms.
|
—
|
22.50 units on a scale
STANDARD_DEVIATION 8.61 • n=20 Participants • The number of ENGAGE-A participants analyzed for the baseline domains differs because two participants had incomplete responses for this questionnaire. The remaining rows differ due to participant withdrawal and loss to follow-up. Behavioral activation data were not collected for clinicians, as this measure is only appropriate for participants experiencing depressive symptoms.
|
|
Behavioral Activation for Depression Scale (BADS)
Domain 3, Baseline
|
13.76 units on a scale
STANDARD_DEVIATION 6.77 • n=21 Participants • The number of ENGAGE-A participants analyzed for the baseline domains differs because two participants had incomplete responses for this questionnaire. The remaining rows differ due to participant withdrawal and loss to follow-up. Behavioral activation data were not collected for clinicians, as this measure is only appropriate for participants experiencing depressive symptoms.
|
—
|
13.76 units on a scale
STANDARD_DEVIATION 6.77 • n=21 Participants • The number of ENGAGE-A participants analyzed for the baseline domains differs because two participants had incomplete responses for this questionnaire. The remaining rows differ due to participant withdrawal and loss to follow-up. Behavioral activation data were not collected for clinicians, as this measure is only appropriate for participants experiencing depressive symptoms.
|
|
Behavioral Activation for Depression Scale (BADS)
Domain 4, Baseline
|
20.25 units on a scale
STANDARD_DEVIATION 6.91 • n=20 Participants • The number of ENGAGE-A participants analyzed for the baseline domains differs because two participants had incomplete responses for this questionnaire. The remaining rows differ due to participant withdrawal and loss to follow-up. Behavioral activation data were not collected for clinicians, as this measure is only appropriate for participants experiencing depressive symptoms.
|
—
|
20.25 units on a scale
STANDARD_DEVIATION 6.91 • n=20 Participants • The number of ENGAGE-A participants analyzed for the baseline domains differs because two participants had incomplete responses for this questionnaire. The remaining rows differ due to participant withdrawal and loss to follow-up. Behavioral activation data were not collected for clinicians, as this measure is only appropriate for participants experiencing depressive symptoms.
|
PRIMARY outcome
Timeframe: 9 WeeksPopulation: The total number of participants that completed all scheduled therapy sessions at week 9. The number of participants analyzed at week 9 for this measure (17) is higher than the number analyzed for the other measures at week 9 (16) because one participant attended the week 9 therapy session but left the study before having completed the week 9 assessment, during which the remaining measures are completed. Clinician Participants were not analyzed for this measure as it does not apply to them.
Number of Virtual ENGAGE-A Participants who Attend Every Scheduled Therapy Session
Outcome measures
| Measure |
Engage-A
n=17 Participants
Participants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding.
Engage-A: Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
|
Clinician Participants
Clinicians who provided the ENGAGE intervention and participated in data collection about their experience.
|
|---|---|---|
|
Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session
|
17 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 weeks, 9 weeks, 12 weeksPopulation: The number of participants analyzed at week 6 was 18, at week 9 was 16, and at week 12 was 15 due to loss to follow up and participant withdrawal. Clinician Participants were not analyzed for this measure as it does not apply to them.
The Client Satisfaction Questionnaire (CSQ) assesses the clients' satisfaction with the services they are receiving. The CSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the program. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the services received. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood of wanting to receive similar services in the future. Higher scores for all three domains indicate a better outcome.
Outcome measures
| Measure |
Engage-A
n=18 Participants
Participants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding.
Engage-A: Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
|
Clinician Participants
Clinicians who provided the ENGAGE intervention and participated in data collection about their experience.
|
|---|---|---|
|
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
Domain 1- week 6
|
2.5 units on a scale
Standard Deviation 0.62
|
—
|
|
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
Domain 2- week 6
|
2.89 units on a scale
Standard Deviation 0.76
|
—
|
|
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
Domain 3- week 6
|
2.83 units on a scale
Standard Deviation 0.79
|
—
|
|
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
Domain 1- week 9
|
2.5 units on a scale
Standard Deviation 0.63
|
—
|
|
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
Domain 2- week 9
|
3.31 units on a scale
Standard Deviation 0.79
|
—
|
|
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
Domain 3- week 9
|
3.33 units on a scale
Standard Deviation 0.90
|
—
|
|
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
Domain 1- week 12
|
2.73 units on a scale
Standard Deviation 0.88
|
—
|
|
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
Domain 2- week 12
|
3.40 units on a scale
Standard Deviation 0.74
|
—
|
|
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
Domain 3- week 12
|
3.27 units on a scale
Standard Deviation 0.88
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Engage-A participants were not analyzed as part of this measure as it does not apply to them.
The Therapist Satisfaction Questionnaire (TSQ) assesses the therapists' satisfaction with the Alacrity therapy training and intervention. The TSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the skills obtained through training. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the therapy type. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood that the therapist would use this therapy in their own practice. Higher scores for all three domains indicate better outcomes.
Outcome measures
| Measure |
Engage-A
Participants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding.
Engage-A: Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
|
Clinician Participants
n=4 Participants
Clinicians who provided the ENGAGE intervention and participated in data collection about their experience.
|
|---|---|---|
|
Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ
Domain 1
|
—
|
4.0 units on a scale
Standard Deviation 0.00
|
|
Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ
Domain 2
|
—
|
4.0 units on a scale
Standard Deviation 0.00
|
|
Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ
Domain 3
|
—
|
4.0 units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline, 6 week, 9 week, 12 weekPopulation: The total number of participants analyzed was 18 at baseline, 18 at week 6, 16 at week 9, and 15 and week 12 due to participant withdrawal and loss to follow-up. Clinician Participants were not analyzed for this measure as it does not apply to them.
Hamilton Depression Rating Score (HAM-D) assesses the severity of depression in patients. The HAM-D ranges from 0 to 52, with higher scores indicating higher severity of depression.
Outcome measures
| Measure |
Engage-A
n=18 Participants
Participants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding.
Engage-A: Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
|
Clinician Participants
Clinicians who provided the ENGAGE intervention and participated in data collection about their experience.
|
|---|---|---|
|
Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D
Baseline
|
21.24 units on a scale
Standard Deviation 5.77
|
—
|
|
Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D
Week 6
|
14.47 units on a scale
Standard Deviation 5.49
|
—
|
|
Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D
Week 9
|
11.19 units on a scale
Standard Deviation 5.65
|
—
|
|
Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D
Week 12
|
11.67 units on a scale
Standard Deviation 6.72
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 week, 9 week, 12 weekPopulation: The number of participants analyzed was 21 at baseline, 18 at week 6, 16 at week 9, and 15 at week 12. Clinician Participants were not analyzed for this measure as it does not apply to them.
The Behavioral Activation for Depression Scale (BADS) measures levels of behavioral activation. The BADS ranges from 0 to 150, with higher scores indicating lower levels of behavioral activation. Domain 1 scores range from 0-42. Higher scores (better outcome) indicate greater activation. Domain 2 scores range from 0-48. Higher scores (worse outcome) indicate greater Avoidance and Rumination. Domain 3 scores range from 0-30. Higher scores (worse outcome) indicate greater Work/School impairment. Domain 4 scores range from 0-30. Higher scores (worse outcome) indicate greater social impairment.
Outcome measures
| Measure |
Engage-A
n=21 Participants
Participants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding.
Engage-A: Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
|
Clinician Participants
Clinicians who provided the ENGAGE intervention and participated in data collection about their experience.
|
|---|---|---|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 1, Baseline
|
18.62 units on a scale
Standard Deviation 10.22
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 2, Baseline
|
22.50 units on a scale
Standard Deviation 8.61
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 3, Baseline
|
13.76 units on a scale
Standard Deviation 6.77
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 4, Baseline
|
20.25 units on a scale
Standard Deviation 6.91
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 1, Week 6
|
24.67 units on a scale
Standard Deviation 7.58
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 2, Week 6
|
27.94 units on a scale
Standard Deviation 8.77
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 3, Week 6
|
16.61 units on a scale
Standard Deviation 7.16
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 4, Week 6
|
22.0 units on a scale
Standard Deviation 7.23
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 1, Week 9
|
27.94 units on a scale
Standard Deviation 7.03
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 2, Week 9
|
30.19 units on a scale
Standard Deviation 11.23
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 3, Week 9
|
20.19 units on a scale
Standard Deviation 5.55
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 4, Week 9
|
23.88 units on a scale
Standard Deviation 5.89
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 1, Week 12
|
24.40 units on a scale
Standard Deviation 10.22
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 2, Week 12
|
31.33 units on a scale
Standard Deviation 12.83
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 3, Week 12
|
21.47 units on a scale
Standard Deviation 7.61
|
—
|
|
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Domain 4, Week 12
|
23.93 units on a scale
Standard Deviation 8.24
|
—
|
Adverse Events
Engage-A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinician Participants
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place