RECRUITING

Brief Versus Standard Cognitive Behavioral Therapy for Insomnia in Veterans

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

Insomnia is a common condition in Veterans, with prevalence rates as high as 53% among treatment-seeking Veterans. Chronic untreated insomnia is associated with increased risk for functional impairment, psychiatric illness, suicidal ideation, unhealthy lifestyles, and decreased quality of life. Cognitive-Behavioral Therapy for Insomnia (CBT-I) is recognized as the first-line treatment for insomnia. Despite its proven efficacy, CBT-I is not always readily provided and/or accessible to Veterans. To address these limitations, behavioral sleep medicine specialists have endeavored to streamline CBT-I through development of time-shortened variations of CBT-I. Although these modifications show promise for advancing care and access, studies comparing brief treatments to standard CBT-I have yet to be performed. This investigation will therefore compare a 4-session brief CBT-I to VA standard 6-session CBT-I to evaluate whether a brief intervention can provide comparable benefits to sleep, functional, and psychiatric outcomes in Veterans with insomnia.

Official Title

A Randomized Clinical Trial Comparing Brief and Standard Cognitive-Behavioral Therapies for Insomnia in Veterans

Quick Facts

Study Start:2023-05-01
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05724498

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. 1. A diagnosis of insomnia as classified by the (a) Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) which includes daytime impairment in functioning for \> 3 months and occurring at least 3 nights per week and (b) subjective sleep disturbance defined by an Insomnia Severity Index (ISI) score \>7 at intake
  2. 2. Meets current DSM 5 criteria for a comorbid mental health disorder
  3. 3. No formal therapist guided treatment with brief or standard Cognitive-Behavioral Therapy for Insomnia within the past 2 years
  4. 4. on stable medication regimen for at least 4 weeks prior to enrollment in study.
  1. 1. History of a acute or unstable neurological disorder(s), dementia, or premorbid IQ \<70
  2. 2. Schizophrenia, psychotic disorder, and/or bipolar disorder
  3. 3. Suicidality more than "medium risk" as determined by the VA Comprehensive Suicide Risk Assessment
  4. 4. Sleep disturbances other than insomnia (e.g., untreated obstructive sleep apnea, periodic limb movements, narcolepsy, and/or circadian-based sleep disruptions)
  5. 5. alcohol and/or substance use disorder for 90 days prior to intake, but past history of alcohol and/or substance use is not exclusionary.

Contacts and Locations

Study Contact

Henry J Orff, PhD
CONTACT
(858) 642-6492
Henry.Orff@va.gov

Principal Investigator

Henry J. Orff, PhD
PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA

Study Locations (Sites)

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
United States
VA Finger Lakes Healthcare System, Canandaigua, NY
Canandaigua, New York, 14424-1159
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Henry J. Orff, PhD, PRINCIPAL_INVESTIGATOR, VA San Diego Healthcare System, San Diego, CA

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 Date2026-10-31

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

  • Insomnia
  • Cognitive-Behavioral Therapy for Insomnia
  • Functional Health
  • Mental Health
  • Veterans

Additional Relevant MeSH Terms

  • Insomnia