Skip to main content
OpenTrials
Completed

NCT Number: NCT05346055

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Engage Prism (2.0)

Behavioral

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2022
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.