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

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05346055
Collaborator
National Institute of Mental Health (NIMH) (NIH)
30
1
1
19.6
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Engage Prism (2.0)
N/A

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
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Delivering 'Engage' Psychotherapy Via Telemedicine Through the Tablet-based 'Prism' System to Homebound Older Adults With Depression
Actual Study Start Date :
May 12, 2022
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Acceptability: Client Satisfaction Questionnaire (CSQ) [9 weeks (end of treatment)]

    The CSQ is a 3 - item questionnaire assessing client satisfaction with the treatment provided at end of treatment (9 weeks). Scores range from 3 (least satisfied) to 12 (most satisfied).

  2. Acceptability: Client Satisfaction Questionnaire (CSQ) [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).

  3. 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 Outcome Measures

  1. 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).

  2. Hamilton Depression Rating Scale [Baseline, 12 weeks (post treatment)]

    Change in depression score from Baseline to 12 weeks post treatment. Scores range from 0 (no depression) to 54 (very severe depression).

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weill Cornell Medicine New York New York United States 10065

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Natalie C Benda, PhD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT05346055
Other Study ID Numbers:
  • 20-10022828
  • 3P50MH113838-02S1
First Posted:
Apr 26, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Weill Medical College of Cornell University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022