RECRUITING

Assessing Improvements in Mood and Sleep Trial

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

This is a multi-site randomized control trial involving people age 55+ years who have current depression symptoms plus another suicide risk indicator (either current suicidal ideation or a past history of attempt). Our goal is evaluate which of two different approaches works best to improve things like trouble sleeping, bad moods, and any suicidality. Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit.

Official Title

Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults

Quick Facts

Study Start:2025-05-20
Study Completion:2030-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06639477

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:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 55 Years and older
  2. * Patient Health Questionnaire -9 score of 10 or higher
  3. * Past month Scale for Suicide Ideation score of 3 or higher OR any history of suicide attempt
  4. * PROMIS Sleep Disturbance or impairment scale t-scores of 55 or higher
  5. * Pharmacotherapy for depression meeting minimum adequate dose level as defined by FDA approval documents for at least 4 weeks.
  1. * Active suicide planning with intent or clinical judgement that suicide risk is too high for outpatient treatment OR being currently treated at an inpatient unit.
  2. * Bipolar disorder
  3. * Psychotic disorder
  4. * Borderline personality disorder.
  5. * Active Cognitive/Behavioral Therapy (e.g., CBT-I), current or upcoming esketamine (ketamine) treatment, or active phase of ECT/TMS treatment course.
  6. * Illness with life expectancy of less than 1 year or plans to leave the study area
  7. * Incapacity to consent/dementia diagnosis
  8. * Active substance use disorder of at least moderate severity
  9. * Active night-shift work

Contacts and Locations

Study Contact

Sara Sellars, M.A
CONTACT
412-246-5963
alberts3@upmc.edu
Stephen Smagula, Ph.D
CONTACT
412-246-6674
smagulasf@upmc.edu

Principal Investigator

Stephen F Smagula, Ph.D
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

The Regents of the University of California, Los Angeles
Los Angeles, California, 90095
United States
Augusta University
Augusta, Georgia, 30912
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Stephen F Smagula, Ph.D, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Date2025-05-20
Study Completion Date2030-08

Study Record Updates

Study Start Date2025-05-20
Study Completion Date2030-08

Terms related to this study

Keywords Provided by Researchers

  • Older Adults
  • Depression

Additional Relevant MeSH Terms

  • Depression
  • Suicidality
  • Sleep