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Clinical Trials/NCT05346055
NCT05346055CompletedNot Applicable

A Pilot Study of Delivering 'Engage' Psychotherapy Via Telemedicine Through the Tablet-based 'Prism' System to Homebound Older Adults With Depression

Weill Medical College of Cornell University1 site in 1 country8 target enrollmentStarted: May 12, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
8
Locations
1
Primary Endpoint
Feasibility: Client Enrollment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

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.

Intervention: Engage Prism (2.0) (Behavioral)

Outcomes

Primary Outcomes

Feasibility: Client Enrollment

Time Frame: Baseline

Feasibility will be measured as the number of clients who are referred to the program, meet eligibility and accept the intervention (versus refuse).

Acceptability: Client Satisfaction Questionnaire (CSQ)

Time Frame: 12 weeks (post treatment)

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).

Acceptability: Client Satisfaction Questionnaire (CSQ)

Time Frame: 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).

Secondary Outcomes

  • Hamilton Depression Rating Scale(Baseline, 12 weeks (post treatment))
  • Hamilton Depression Rating Scale(Baseline, 9 weeks (end of treatment))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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