The Feasibility of Engage Therapy With Video Support for Homebound Older Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Engage Prism (2.0)

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: Engage Prism (2.0); Brief Behavioral Treatment for Depression (Engage) combined with tablet-based social support system (Prism 2.0)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Natalie C Benda, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Older Adults
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 20-10022828; 3P50MH113838-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No