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| ID | Type | Description | Link |
|---|---|---|---|
| 3P50MH113838-02S1 | 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 primary aim in this pilot project is to test the feasibility, acceptability and impact (decreased depressive symptoms) of a brief behavioral treatment for depression (Engage) combined with video social support (PRISM 2.0) among socially isolated/lonely case management clients who endorse depressive symptoms. Eligible participants will be offered the combination of Engage and Prism 2.0, called Engage-Prism. The investigators hypothesize that the intervention (Engage Therapy With Video Support) will be accepted by participants, improve depressive symptom, and be feasible to complete.
Engage is a brief therapy designed to offer a structured, stepped approach and interventions to reduce barriers to increased engagement with rewarding activities to improve depression (Alexopoulos et al, 2020). The goal is to increase participation in meaningful activities. Homebound older adults have limited social interaction given their restricted mobility and medical burden. In prior research with an intervention targeting social engagement with a technology intervention (PRISM 2.0), participants reported increased social support, decreased loneliness, increased feelings of well-being, more positive attitudes about computers, and gains in computer proficiency (Czaja et al., 2017).
Participants will be referrals from case management service. Clinicians will incorporate elements of the Prism system into therapy as appropriate, and participants will be instructed to use the Prism system at their leisure or as it pertains to their chosen "reward exposure" activities. There will be a post-therapy assessment and interview about their experience with the technology at week 9. The study will conclude with follow-up assessments at week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Engage Prism 2.0 | Other | Engage Prism is a 9-week program that integrates Engage- a form of behavioral talk therapy treating depression, and guided use of Prism technology- a software that aims to improve social support and interaction of older adults. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engage Prism (2.0) | Behavioral | Brief Behavioral Treatment for Depression (Engage) combined with tablet-based social support system (Prism 2.0) |
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| Measure | Description | Time Frame |
|---|---|---|
| Acceptability: Client Satisfaction Questionnaire (CSQ) | The CSQ is a 3 - item questionnaire assessing client satisfaction with the treatment provided partway through the treatment (6 weeks). Scores range from 3 (least satisfied) to 12 (most satisfied). | 6 weeks (part-way through treatment) |
| Acceptability: Client Satisfaction Questionnaire (CSQ) | The CSQ is a 3 - item questionnaire assessing client satisfaction with the treatment provided assessed at 3 weeks post treatment (at 12 weeks) Scores range from 3 (least satisfied) to 12 (most satisfied). | 12 weeks (post treatment) |
| Feasibility: Client Enrollment | Feasibility will be measured as the number of clients who are referred to the program, meet eligibility and accept the intervention (versus refuse). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale | Change in depression scores from Baseline to 9 weeks. Scores range from 0 (no depression) to 54 (very severe depression). | Baseline, 9 weeks (end of treatment) |
| Hamilton Depression Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie C Benda, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
Individual participant data that underlie the results in publications after de-identification, as well as study protocol, treatment manuals, statistical analysis plan and informed consent.
After we publish the main results, we will make de-identified data available to other researchers under a data sharing agreement overseen by Weill Cornell Alacrity Center's executive committee.
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. All researchers requesting data solely for research purpose; secure the data; return or destroy it once analyses are completed; do not share it with other researchers.
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Participants were recruited from the Virtual Senior Center, a community-building platform that helps older and homebound adults connect and engage with each other through virtual and hybrid classes. Recruitment efforts included online message board posts, emails, and virtual information sessions (via Zoom). Prospective participants contacted a study team member via phone or email and completed screening via phone. Participants were recruited between April 1, 2022 and June 30, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Engage Prism 2.0 | Engage Prism is a 9-week program that integrates Engage- a form of behavioral talk therapy treating depression, and guided use of Prism technology- a software that aims to improve social support and interaction of older adults. Engage Prism (2.0): Brief Behavioral Treatment for Depression (Engage) combined with tablet-based social support system (Prism 2.0) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Engage Prism 2.0 | Engage Prism is a 9-week program that integrates Engage- a form of behavioral talk therapy treating depression, and guided use of Prism technology- a software that aims to improve social support and interaction of older adults. Engage Prism (2.0): Brief Behavioral Treatment for Depression (Engage) combined with tablet-based social support system (Prism 2.0) |
| Units | Counts |
|---|---|
| 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 | Acceptability: Client Satisfaction Questionnaire (CSQ) | The CSQ is a 3 - item questionnaire assessing client satisfaction with the treatment provided partway through the treatment (6 weeks). Scores range from 3 (least satisfied) to 12 (most satisfied). | All participants completing the study were analyzed, although one participant is not included due to a database error. Those who did not complete the study could not complete the post-study CSQ. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks (part-way through treatment) |
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Adverse events were collected throughout the 9-week study period and 3-week follow up period (12 weeks total).
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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 Prism 2.0 | Engage Prism is a 9-week program that integrates Engage- a form of behavioral talk therapy treating depression, and guided use of Prism technology- a software that aims to improve social support and interaction of older adults. Engage Prism (2.0): Brief Behavioral Treatment for Depression (Engage) combined with tablet-based social support system (Prism 2.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jo Anne Sirey | Weill Cornell Medical College | 914-997-4333 | jsirey@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 | Yes | No | No | Study Protocol | Nov 20, 2020 | May 25, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2022 | May 25, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Change in depression score from Baseline to 12 weeks post treatment. Scores range from 0 (no depression) to 54 (very severe depression).
| Baseline, 12 weeks (post treatment) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Acceptability: Client Satisfaction Questionnaire (CSQ) | The CSQ is a 3 - item questionnaire assessing client satisfaction with the treatment provided assessed at 3 weeks post treatment (at 12 weeks) Scores range from 3 (least satisfied) to 12 (most satisfied). | Five total participants completed the study and 12-week follow up. Only 2 are included as three records were lost due to a databases error. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks (post treatment) |
|
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| Primary | Feasibility: Client Enrollment | Feasibility will be measured as the number of clients who are referred to the program, meet eligibility and accept the intervention (versus refuse). | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Hamilton Depression Rating Scale | Change in depression scores from Baseline to 9 weeks. Scores range from 0 (no depression) to 54 (very severe depression). | Five participants completed this phase of the treatment, but only 3 are included as 2 were lost due to a database error. | Posted | Mean | Standard Deviation | difference in pre/post score on a scale | Baseline, 9 weeks (end of treatment) |
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| Secondary | Hamilton Depression Rating Scale | Change in depression score from Baseline to 12 weeks post treatment. Scores range from 0 (no depression) to 54 (very severe depression). | Five participants completed this phase of the treatment, but only 2 are included as 3 were lost due to a database error. | Posted | Mean | Standard Deviation | difference in pre/post score on a scale | Baseline, 12 weeks (post treatment) |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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