An interventional study of Engage Prism (2.0) in Depression, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 8 is below the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
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.
Behavioral: Engage Prism (2.0)
Brief Behavioral Treatment for Depression (Engage) combined with tablet-based social support system (Prism 2.0)
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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline
Hamilton Depression Rating Scale
Change in depression scores from Baseline to 9 weeks. Scores range from 0 (no depression) to 54 (very severe depression).
Time frame: Baseline, 9 weeks (end of treatment)
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).
Time frame: Baseline, 12 weeks (post treatment)
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.
| Milestone | Engage Prism 2.0 |
|---|---|
| Started | 8 |
| Completed | 5 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Therapist decision | 1 |
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).
| score on a scale | Engage Prism 2.0 |
|---|---|
| Acceptability: Client Satisfaction Questionnaire (CSQ) | 10.5 ± 4.34 |
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).
| score on a scale | Engage Prism 2.0 |
|---|---|
| Acceptability: Client Satisfaction Questionnaire (CSQ) | 9 ± 0 |
Feasibility will be measured as the number of clients who are referred to the program, meet eligibility and accept the intervention (versus refuse).
| Participants | Engage Prism 2.0 |
|---|---|
| Feasibility: Client Enrollment | 8 |
Change in depression scores from Baseline to 9 weeks. Scores range from 0 (no depression) to 54 (very severe depression).
| difference in pre/post score on a scale | Engage Prism 2.0 |
|---|---|
| Hamilton Depression Rating Scale | 8.67 ± 2.52 |
Change in depression score from Baseline to 12 weeks post treatment. Scores range from 0 (no depression) to 54 (very severe depression).
| difference in pre/post score on a scale | Engage Prism 2.0 |
|---|---|
| Hamilton Depression Rating Scale | 0.5 ± 0.707 |
Collected over Adverse events were collected throughout the 9-week study period and 3-week follow up period (12 weeks total).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Engage Prism 2.0 | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(years) | Engage Prism 2.0 |
|---|---|
| Mean | 73.88 ± 6.58 |
| Sex: Female, Male(Participants) | Engage Prism 2.0 |
|---|---|
| Female | 6 |
| Male | 2 |
| Race/Ethnicity, Customized(Participants) | Engage Prism 2.0 |
|---|---|
| White | 7 |
| Black/African American | 1 |
| Region of Enrollment(participants) | Engage Prism 2.0 |
|---|---|
| United States | 8 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University