Clinical trial NCT05346055: The Feasibility of Engage Therapy With Video Support for Homebound Older Adults
Official title: A Pilot Study of Delivering 'Engage' Psychotherapy Via Telemedicine Through the Tablet-based 'Prism' System to Homebound Older Adults With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Older Adults
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-04-26
Enrollment: 8
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability: Client Satisfaction Questionnaire (CSQ)
timeFrame: 6 weeks (part-way through treatment)
measure: Acceptability: Client Satisfaction Questionnaire (CSQ)
timeFrame: 12 weeks (post treatment)
measure: Feasibility: Client Enrollment
timeFrame: Baseline
Secondary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: Baseline, 9 weeks (end of treatment)
measure: Hamilton Depression Rating Scale
timeFrame: Baseline, 12 weeks (post treatment)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Natalie C Benda, PhD
role: PRINCIPAL_INVESTIGATOR
References: