NCT06039930 Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
| NCT ID | NCT06039930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-09-22 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2023-09-22 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this randomized trial is to conduct a fully powered effectiveness trial of video-delivered PROTECT (Tele-PROTECT) compared to a video-delivered depression education (DepEd) control condition to be delivered to 140 English- and Spanish-speaking NYC elder abuse victims. Investigators hypothesize three main aims: 1. Effectiveness Aim: Tele-PROTECT participants will have significantly greater and clinically meaningful reductions in depression when compared to the DepEd control; 2. Abuse Impact Aim: Tele-PROTECT participants will demonstrate greater safety related empowerment compared to DepEd control, which can help participants take steps to reduce risk; 3. Implementation Aim: Stakeholders' views of the factors impacting the implementation of Tele-PROTECT based on characteristics of the intervention, agency setting, and population served will contribute to a national dissemination of Tele-PROTECT Participants will * Receive 9 weeks of tele health psychotherapy delivered by a Master's level mental health clinician from the Weill Cornell Medicine research team. Participants will be assigned to "Tele-PROTECT" or "DepEd" psychotherapy randomly. * Participate in one baseline assessment and four follow-up assessments at weeks 3, 6, 9, and 12 administered by a trained member of the research team.
Eligibility Criteria
Inclusion Criteria: * ≥60 years of age * Capacity to consent (per elder abuse staff) * Depression, i.e., PHQ-9≥10 (by elder abuse staff), represents mild to moderate severity of depression and has a sensitivity of 88% and a specificity of 88% for major depression * Need for elder abuse services as verified by the elder abuse case worker. Exclusion Criteria: * Active suicidal ideation (MADRS item 10 ≥4) * Inability to speak English or Spanish * Axis 1 DSM-5 diagnoses other than unipolar depression or comorbid generalized anxiety disorder (by SCID) * Mini-MOCA less than 11 * Severe or life-threatening medical illness * Elder abuse emergency and or referral out of elder abuse agency.
Contact & Investigator
Jo Anne Sirey, Ph.D
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT06039930 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06039930 currently recruiting?
Yes, NCT06039930 is actively recruiting participants. Contact the research team at jsirey@med.cornell.edu for enrollment information.
Where is the NCT06039930 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06039930 clinical trial?
NCT06039930 is sponsored by Weill Medical College of Cornell University. The principal investigator is Jo Anne Sirey, Ph.D at Weill Medical College of Cornell University. The trial plans to enroll 140 participants.
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