NCT04289298

Brief Summary

The purpose of this study is to test the feasibility of one type of therapy session, Virtual Augmented Engage (Engage-A). The research is being done because the researchers are trying to learn if these approaches could be used by therapists in the community social service agencies to treat older adults with depression. The research will also measure clinician satisfaction after training and supervision of utilization of Engage-A.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 3, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 23, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

February 26, 2020

Results QC Date

June 28, 2023

Last Update Submit

August 3, 2023

Conditions

Keywords

depressiongeriatricpsychotherapygroup

Outcome Measures

Primary Outcomes (3)

  • Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session

    Number of Virtual ENGAGE-A Participants who Attend Every Scheduled Therapy Session

    9 Weeks

  • Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ

    The Client Satisfaction Questionnaire (CSQ) assesses the clients' satisfaction with the services they are receiving. The CSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the program. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the services received. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood of wanting to receive similar services in the future. Higher scores for all three domains indicate a better outcome.

    6 weeks, 9 weeks, 12 weeks

  • Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ

    The Therapist Satisfaction Questionnaire (TSQ) assesses the therapists' satisfaction with the Alacrity therapy training and intervention. The TSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the skills obtained through training. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the therapy type. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood that the therapist would use this therapy in their own practice. Higher scores for all three domains indicate better outcomes.

    2 years

Secondary Outcomes (2)

  • Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D

    Baseline, 6 week, 9 week, 12 week

  • Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS

    Baseline, 6 week, 9 week, 12 week

Study Arms (2)

Engage-A

EXPERIMENTAL

Participants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding.

Behavioral: Engage-A

Clinician

EXPERIMENTAL

Clinicians will be trained in Engage-A and supervised while utilizing the therapy.

Other: Training and utilizing Engage-A therapy

Interventions

Engage-ABEHAVIORAL

Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.

Also known as: Augmented Engage
Engage-A

Therapist will be trained in Engage-A therapy and given supervision while utilizing this therapy.

Clinician

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 55 years' old
  • PHQ-9 Score of ≥ 10
  • English or Spanish speaking
  • MOCA ≥ 24 or mini-telephone MOCA ≥ 11
  • Member of/attends one of the REDS Senior Centers
  • Capacity to provide written consent for both research assessment and the Engage-A intervention.

You may not qualify if:

  • Current active suicidal ideation defined by MADRS Suicide Item ≥ 4 (probably better off dead. Suicidal thoughts are common, and suicide is considered as a possible solution, but without specific plans or intention).
  • Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder by SCID-IV.
  • Severe or life-threatening medical illness (e.g., end stage organ failure).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Patricia Marino, PhD
Organization
Weill Cornell Medical College

Study Officials

  • Patricia Marino, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2020

First Posted

February 28, 2020

Study Start

September 3, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

August 23, 2023

Results First Posted

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.

Time Frame
Data will be available as per NIMH's data sharing policy.
Access Criteria
Access criteria is determined by NIMH and can be requested by applying online.
More information

Locations