Tele-Self CBTI Trial

NCT ID: NCT03727438

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2023-04-01

Brief Summary

Insomnia is one of the most common complaints among service-members and Veterans of recent military conflicts. Insomnia has been shown to play a causal role in mental health, hypertension, obesity, and other health conditions, increasing risk for all-cause mortality. Cognitive-Behavioral Therapy for Insomnia (CBTI) produces both short-term and sustained resolution of insomnia with fewer adverse side effects than medications, but access to behavioral sleep medicine expertise within the VA is very limited.

This study compares Tele-Self CBTI to Health Education Control for improved insomnia severity among treatment-seeking Veterans with Insomnia. In this study, 200 participants will be randomized with a 50/50 chance to either Tele-Self CBTI or a Health Education Control condition. Eligible participants are Veterans who are: a) prescribed sleep medications; b) diagnosed with insomnia; and/or c) referred for clinic-based CBTI (but not yet treated) for insomnia. Participants will be identified using electronic health records (EHR) and telephone interviews.

Participants' sleep will be assessed at three time points, at Baseline, 8 weeks and 6 months after Baseline. The Tele-Self CBTi intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 8 week intervention period. Participants randomized to Tele-Self CBTI will complete 6 weekly readings in addition to having 6 weekly telephone contacts with a study nurse; each call lasting approximately 20 minutes. Patients randomized to Health Education Control (HEC) will receive a health education manual on 6 health topics. They will also complete 6 weekly readings from the HEC manual and receive 6 weekly telephone contacts from a study nurse. All participants will continue to receive usual medical care while participating in the study. Following completion of this 6 month study, participants randomized to HEC and interested in additional help for their sleep will be referred to the Durham VA Behavioral Sleep Medicine Clinic.

Detailed Description

Insomnia is one of the most common complaints among service-members and Veterans of recent military conflicts. Insomnia diagnoses increased 19-fold among military service members from 2000 to 2009. Insomnia has been shown to play a causal role in depression, anxiety, suicidality, disability due to a mental health disorder, hypertension, obesity, metabolic syndrome, diabetes, and all-cause mortality, thus serving as an additional risk factor for some of the most common medical conditions seen in patients utilizing the VA healthcare system. Cognitive-Behavioral Therapy for Insomnia (CBTI) produces both short-term and sustained resolution of insomnia with fewer adverse side effects than pharmacotherapy. But access to behavioral sleep medicine expertise within the VA is very limited.

Self-management and telehealth are viable options for achieving these goals. This study is a randomized controlled trial comparing Tele-Self CBTI to Health Education Control (HEC) for improved insomnia severity among treatment-seeking Veterans with Insomnia. In this 2-arm trial, 200 participants will be randomized in a 1:1 ratio to Tele-Self CBTI or a Health Education Control condition. Eligible participants are Veterans who are: a) prescribed sleep medications; b) diagnosed with insomnia; or c) referred for clinic-based CBTI (but not yet treated) will be identified using electronic health records (EHR) and telephone interviews.

Outcomes include insomnia severity in addition to subjective (sleep diary) and objective (actigraphy) measures of sleep variables, including: sleep onset latency (SOL), wakefulness after sleep onset (WASO), and sleep efficiency (SE). These outcomes will be assessed at 3 time points: baseline, 8 weeks, and 6 months after baseline. Participants in both arms will continue to receive usual medical care. Each assessment period involves: a) 2 weeks of home-based sleep assessment (diary and actigraphy), and b) completion of telephone-based questionnaires. Following completion of each home-based sleep assessment period, a study staff member will contact participants to complete study questionnaires by phone. Study participants will be asked to return actigraphy devices at the end of each assessment period.

Tele-Self CBTI is comprised of two treatment components: 1) Self-directed treatment via a treatment manual entitled, "Improve your Sleep: A Self-Guided Approach for Veterans with Insomnia" and 2) telephone-based nurse support. Participants will complete 6 weekly reading modules from the treatment manual on topics reflecting typical CBTI treatment components: Sleep Restriction; Stimulus Control; Cognitive Therapy; Relaxation; and Sleep Hygiene Education. Tele-Self CBTI will be delivered across 6 weekly telephone contacts of 20 minutes or less through a study nurse who will briefly review treatment manual content with the participant, review sleep diaries, and create and adjust sleep prescriptions as needed. Patients randomized to Health Education Control (HEC) will completed weekly readings and receive 6 weekly phone calls from a study nurse. Consistent with phone contacts in the intervention arm, HEC phone contacts will involve reviewing content in the health education manual and will last approximately 20 minutes; matching as closely as possible call duration with Tele-Self CBTI participants. Sleep-focused content will be prohibited during HEC calls. Participants have 8 weeks to complete the 6 phone calls.

Conditions

Insomnia Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Tele-Self CBTI

Tele-Self CBTi is a telephone-based CBT insomnia intervention

Group Type: EXPERIMENTAL

Tele-Self CBTI

Intervention Type: BEHAVIORAL

The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 8 week intervention period. Participants have 8 weeks to complete 6 study-related phone calls

Health Education Control

The Health Education is an active control arm

Group Type: ACTIVE_COMPARATOR

Health Education Control

Intervention Type: OTHER

The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 8 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.

Interventions

Tele-Self CBTI

The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 8 week intervention period. Participants have 8 weeks to complete 6 study-related phone calls

Intervention Type: BEHAVIORAL

Health Education Control

The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 8 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.

Intervention Type: OTHER

Other Intervention Names

Control

Eligibility Criteria

Inclusion Criteria

• Meets diagnostic criteria for Insomnia Disorder
• Receives care through the Durham VA Health Care System (HCS) catchment area

Exclusion Criteria

• Severe Obstructive Sleep Apnea with treatment non-adherence
• Unstable co-morbid sleep disorder determined via chart review

• e.g., rule out for Narcolepsy, rule out for Shift Work Disorder
• Current or prior participation in Cognitive Behavioral Therapy for Insomnia (CBTI)
• Excessive daytime sleepiness
• Nighttime or rotating shift work within the last year
• Psychotic disorder diagnosis
• Bipolar disorder diagnosis
• Recreational substance use
• Current alcohol abuse
• Severe depression or suicidality
• Dementia diagnosis
• Cognitive impairment
• Epilepsy diagnosis
• Seizure disorder diagnosis
• Lack of proficiency in the English language
• Hearing impairment that impedes telehealth intervention
• Unable to complete study procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christi S. Ulmer, PhD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

References

Ulmer CS, McCant F, Stechuchak KM, Olsen M, Bosworth HB. Prevalence of insomnia disorder and sleep apnea in a sample of veterans at risk for cardiovascular disease. J Clin Sleep Med. 2021 Jul 1;17(7):1441-1446. doi: 10.5664/jcsm.9228.

Reference Type: BACKGROUND

PMID: 33688827 (View on PubMed)

Ulmer CS, Bosworth HB, Zervakis J, Goodwin K, Gentry P, Rose C, Jeffreys AS, Olsen MK, Weidenbacher HJ, Beckham JC, Voils CI. Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial. Contemp Clin Trials. 2023 Feb;125:107060. doi: 10.1016/j.cct.2022.107060. Epub 2022 Dec 22.

Reference Type: RESULT

PMID: 36567058 (View on PubMed)

Ulmer CS, Voils CI, Jeffreys AS, Olsen M, Zervakis J, Goodwin K, Gentry P, Rose C, Weidenbacher HJ, Beckham JC, Bosworth HB. Nurse-Supported Self-Directed Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial. JAMA Intern Med. 2024 Nov 1;184(11):1356-1364. doi: 10.1001/jamainternmed.2024.4419.

Reference Type: RESULT

PMID: 39250131 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1I01HX002350-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IIR 16-281

Identifier Type: -

Identifier Source: org_study_id