Depression
Conditions
Keywords
Older Adults
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALEngage Prism (2.0)
Brief Behavioral Treatment for Depression (Engage) combined with tablet-based social support system (Prism 2.0)
Sponsors
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age at least 60 years * English speaking * Currently enrolled in case management at in 2 included agencies * Major depression on the SCID * 24-item Hamilton Depression Rating Scale (HAM-D) ≥ 19
Exclusion criteria
* Psychotic depression by SCID-V, i.e. presence of delusions * High suicide risk, i.e. intent or plan to attempt suicide in the near future * Presence of any Axis I psychiatric disorder * Presence of substance abuse other than unipolar major depression * History of psychiatric disorders, hypomania, are excluded * Acute or severe medical illness, i.e. delirium, metastatic cancer, decompensated cardiac, liver, or kidney failure, major surgery, stroke, or myocardial infarction during the three months prior to entry; or drugs often causing depression, e.g. steroids, reserpine, alpha- methyl-dopa, tamoxiphen, vincristine * Current involvement in psychotherapy * Cognitive impairment (i.e. telephone administered MoCA \< 11) * Currently dwelling in non-community dwelling (e.g. prison, nursing home) * Hearing that would not allow participants to complete sessions with the RA/therapist * Vision impairment that would not allow the participant to use the study provided tablet * Inability to speak English * Aphasia interfering with communication * Literacy -assessed by reading a paragraph designed for those at 6th grade reading level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability: Client Satisfaction Questionnaire (CSQ) | 6 weeks (part-way through treatment) | 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). |
| Feasibility: Client Enrollment | Baseline | Feasibility will be measured as the number of clients who are referred to the program, meet eligibility and accept the intervention (versus refuse). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale | Baseline, 9 weeks (end of treatment) | Change in depression scores from Baseline to 9 weeks. Scores range from 0 (no depression) to 54 (very severe depression). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Therapist decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Engage Prism 2.0 |
|---|---|
| Age, Continuous | 73.88 years STANDARD_DEVIATION 6.58 |
| Race/Ethnicity, Customized Black/African American | 1 Participants |
| Race/Ethnicity, Customized White | 7 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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).
Time frame: 6 weeks (part-way through treatment)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Engage Prism 2.0 | Acceptability: Client Satisfaction Questionnaire (CSQ) | 10.5 score on a scale | Standard Deviation 4.34 |
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).
Time frame: 12 weeks (post treatment)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Engage Prism 2.0 | Acceptability: Client Satisfaction Questionnaire (CSQ) | 9 score on a scale | Standard Deviation 0 |
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).
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Engage Prism 2.0 | Feasibility: Client Enrollment | 8 Participants |
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).
Time frame: Baseline, 9 weeks (end of treatment)
Population: Five participants completed this phase of the treatment, but only 3 are included as 2 were lost due to a database error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Engage Prism 2.0 | Hamilton Depression Rating Scale | 8.67 difference in pre/post score on a scale | Standard Deviation 2.52 |
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).
Time frame: Baseline, 12 weeks (post treatment)
Population: Five participants completed this phase of the treatment, but only 2 are included as 3 were lost due to a database error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Engage Prism 2.0 | Hamilton Depression Rating Scale | 0.5 difference in pre/post score on a scale | Standard Deviation 0.707 |