Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk

NCT ID: NCT03366870

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-24
• Study Completion Date: 2020-06-16

Brief Summary

Insomnia is major problem among Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Insomnia impacts physical and mental health functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to CBT-I is severely limited by a lack of trained clinicians within the Veterans Health Administration (VHA) and Department of Defense (DoD). There is a critical need to offer innovative approaches to meet the demand and need for insomnia treatment. Leveraging technology to meet treatment demands is consistent with service delivery models based upon stepped care principles. This randomized controlled trial will determine whether a computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning compared to a computerized program control.

Conditions

Insomnia; Physical Health Functioning; Mental Health Functioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Computerized Intervention 1

A web-based program will deliver components of CBT-I on a time and event-based schedule. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention.

Group Type: EXPERIMENTAL

Computerized Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I.

Computerized Intervention 2

A web-based program will deliver components of sleep education via an Internet platform. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention.

Group Type: EXPERIMENTAL

Sleep Education

Intervention Type: BEHAVIORAL

A web-based program will deliver components of sleep education via an Internet platform.

Interventions

Computerized Cognitive Behavioral Therapy for Insomnia

A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I.

Intervention Type: BEHAVIORAL

Sleep Education

A web-based program will deliver components of sleep education via an Internet platform.

Intervention Type: BEHAVIORAL

Other Intervention Names

cCBT-I

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 55

2. History of deployment in the Global War on Terror

3. Eligible to receive care through VA ECHCS

4. Reliable access to the Internet

5. English speaking

6. Able to provide informed consent

7. Current insomnia diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) criteria

Exclusion Criteria

1. Currently enrolled in/participating in other intervention research studies

2. Other untreated sleep disorders (e.g., sleep apnea, periodic limb movement)

3. Currently receiving formal psychological treatment for insomnia (not including sleep medications)

4. Past 3 month change in schedule and/or dosage of medications that are designed to improve/impact sleep

5. History of Bipolar Disorder (with manic episodes), Schizophrenia, Schizoaffective Disorder, or a Psychotic Disorder

6. Untreated seizures or seizure disorder

7. Physical illness that is active, unstable, degenerative, and/or progressive

8. Currently pregnant or plan to become pregnant in the next 6 months

9. Irregular work schedule, shift work, and/or life changes (e.g., new baby) interfering with regular sleep patterns

10. Significant cognitive impairment, as determined by chart review and/or during screening, that would interfere with ability to engage in SHUTi

11. Current non-alcohol Substance Use Disorder, excluding Cannabis Use Disorder, as determined by chart review and/or self-report screen of drug use (> 1 time) in past 3 months

12. Current Alcohol Use Diagnosis, as determined by SCID 5 module, in the past 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Military Suicide Research Consortium

OTHER

Sponsor Role: collaborator

Denver Research Institute

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarra Nazem, PhD

Role: PRINCIPAL_INVESTIGATOR

VHAECH

Locations

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Countries

United States

References

Nazem S, Barnes SM, Forster JE, Hostetter TA, Monteith LL, Kramer EB, Gaeddert LA, Brenner LA. Efficacy of an Internet-Delivered Intervention for Improving Insomnia Severity and Functioning in Veterans: Randomized Controlled Trial. JMIR Ment Health. 2023 Nov 24;10:e50516. doi: 10.2196/50516.

Reference Type: DERIVED

PMID: 37999953 (View on PubMed)

Other Identifiers

17-0920

Identifier Type: -

Identifier Source: org_study_id