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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346055
• Other study ID #: 20-10022828
• Secondary ID: 3P50MH113838-02S
• Status: Completed
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

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

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)