RECRUITING

Digital CBT for Insomnia and Depression

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 study has two primary objectives, each of which addresses critical clinical and research gaps for individuals who have co-occurring insomnia and depression. The first objective is to address whether sequential treatment of insomnia and depression is superior to a single treatment for either depression or for insomnia, and if so, which treatment sequence is optimal. The second objective is to determine if there are heterogeneity of treatment effects; that is, variation in which interventions are best for which individuals, and if so, to develop and individualized intervention rule to better match individuals with the treatment that is most likely to lead to the best outcomes. A large randomized trial will be conducted to meet these objectives.

Official Title

Optimizing Digital Behavioral Treatment for Co-occurring Insomnia and Depression

Quick Facts

Study Start:2023-05-01
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05456607

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English-speaking
  2. * U.S. Military Veterans
  3. * endorse depression (Patient Health Questionnaire-depression score \> 10)
  4. * endorse insomnia (Insomnia Severity Index score \> 10).
  5. * pregnancy
  6. * history of bipolar disorder
  7. * history of psychosis
  8. * current use of anti-psychotic medications or mood stabilizers (e.g., lithium)
  9. * current suicidal ideation with active intent
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Wilfred Pigeon, PhD
CONTACT
(585) 275-2900
wilfred_pigeon@urmc.rochester.edu
Michelle Carr, PhD
CONTACT
(585) 275-2900
michelle_carr@urmc.rochester.edu

Principal Investigator

Wilfred Pigeon, PhD
PRINCIPAL_INVESTIGATOR
University of Rochester

Study Locations (Sites)

University of Rochester Sleep Research Laboratory
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: University of Rochester

  • Wilfred Pigeon, PhD, PRINCIPAL_INVESTIGATOR, University of Rochester

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 Date2023-05-01
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • cognitive behavioral therapy
  • digital intervention
  • depression
  • insomnia

Additional Relevant MeSH Terms

  • Depression
  • Insomnia