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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50MH113838-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to test the feasibility of one type of therapy session, Virtual Augmented Engage (Engage-A). The research is being done because the researchers are trying to learn if these approaches could be used by therapists in the community social service agencies to treat older adults with depression. The research will also measure clinician satisfaction after training and supervision of utilization of Engage-A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Engage-A | Experimental | 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. |
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| Clinician | Experimental | Clinicians will be trained in Engage-A and supervised while utilizing the therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engage-A | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session | Number of Virtual ENGAGE-A Participants who Attend Every Scheduled Therapy Session | 9 Weeks |
| Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | 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. | 6 weeks, 9 weeks, 12 weeks |
| Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D | 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. | Baseline, 6 week, 9 week, 12 week |
| Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Marino, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | White Plains | New York | 10605 | United States |
De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.
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Data will be available as per NIMH's data sharing policy.
Access criteria is determined by NIMH and can be requested by applying online.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Clinician Participants | Clinicians who provided the ENGAGE intervention and participated in data collection about their experience. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session | Number of Virtual ENGAGE-A Participants who Attend Every Scheduled Therapy Session | 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. | Posted | Count of Participants | Participants | 9 Weeks |
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Adverse event data were collected over 12 weeks for each Engage-A participant.
Engage-A participants were assessed for adverse events. Clinicians were not assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patricia Marino, PhD | Weill Cornell Medical College | 914-997-8691 | pam2029@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2022 | Jul 25, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 6, 2022 | Jul 25, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Training and utilizing Engage-A therapy | Other | Therapist will be trained in Engage-A therapy and given supervision while utilizing this therapy. |
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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. |
| Baseline, 6 week, 9 week, 12 week |
| BG001 | Clinician Participants | Clinicians who provided the ENGAGE intervention and participated in data collection about their experience. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hamilton Psychiatric Rating Scale for Depression (HAM-D) | 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. | 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. | Mean | Standard Deviation | units on a scale |
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| Behavioral Activation for Depression Scale (BADS) | 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. | 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. | Mean | Standard Deviation | units on a scale |
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| OG001 | Clinician Participants | Clinicians who provided the ENGAGE intervention and participated in data collection about their experience. |
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| Primary | Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks, 9 weeks, 12 weeks |
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| Primary | Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ | 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. | Engage-A participants were not analyzed as part of this measure as it does not apply to them. | Posted | Mean | Standard Deviation | units on a scale | 2 years |
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| Secondary | Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 week, 9 week, 12 week |
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| Secondary | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 week, 9 week, 12 week |
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| 22 |
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| EG001 | Clinician Participants | Clinicians who provided the ENGAGE intervention and participated in data collection about their experience. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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