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

NCT05346055 | Completed Results DMC

• 2 other identifiers: 20-100228283P50MH113838-02S1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Older Adults

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

Secondary Outcomes (2)

• Hamilton Depression Rating Scale

  Baseline, 9 weeks (end of treatment)

• Hamilton Depression Rating Scale

  Baseline, 12 weeks (post treatment)

Study Arms (1)

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.

Behavioral: Engage Prism (2.0)

Interventions

Engage Prism (2.0) BEHAVIORAL

Brief Behavioral Treatment for Depression (Engage) combined with tablet-based social support system (Prism 2.0)

Engage Prism 2.0

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at least 60 years
• English speaking
• Currently enrolled in case management at in 2 included agencies
• Major depression on the SCID
• item Hamilton Depression Rating Scale (HAM-D) ≥ 19

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Jo Anne Sirey
• Organization: Weill Cornell Medical College

jsirey@med.cornell.edu

914-997-4333

Study Officials

• Natalie C Benda, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: May 12, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)