RECRUITING

Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation

Quick Facts

Study Start:2023-09-22
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06039930

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥60 years of age
  2. * Capacity to consent (per elder abuse staff)
  3. * 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
  4. * Need for elder abuse services as verified by the elder abuse case worker.
  1. * Active suicidal ideation (MADRS item 10 ≥4)
  2. * Inability to speak English or Spanish
  3. * Axis 1 DSM-5 diagnoses other than unipolar depression or comorbid generalized anxiety disorder (by SCID)
  4. * Mini-MOCA less than 11
  5. * Severe or life-threatening medical illness
  6. * Elder abuse emergency and or referral out of elder abuse agency.

Contacts and Locations

Study Contact

Jo Anne Sirey, Ph.D
CONTACT
914-997-4333
jsirey@med.cornell.edu

Principal Investigator

Jo Anne Sirey, Ph.D
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Jo Anne Sirey, Ph.D, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-22
Study Completion Date2028-03

Study Record Updates

Study Start Date2023-09-22
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • Elder Abuse
  • Depression
  • Mental Health

Additional Relevant MeSH Terms

  • Depression
  • Elder Abuse