Reaching and Engaging Depressed Senior Center Clients
REDS II
2 other identifiers
interventional
26
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Typical duration for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedStudy Start
First participant enrolled
September 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedResults Posted
Study results publicly available
August 23, 2023
CompletedAugust 23, 2023
August 1, 2023
2 years
February 26, 2020
June 28, 2023
August 3, 2023
Conditions
Keywords
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
EXPERIMENTALParticipants 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.
Clinician
EXPERIMENTALClinicians will be trained in Engage-A and supervised while utilizing the therapy.
Interventions
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.
Therapist will be trained in Engage-A therapy and given supervision while utilizing this therapy.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Patricia Marino, PhD
- Organization
- Weill Cornell Medical College
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Marino, PhD
Weill Medical College of Cornell University
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
- 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.
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.