Tele-Self CBTI Trial (Tele-Self CBTI)

September 18, 2024 updated by: VA Office of Research and Development

Provider Supported Self-Help Cognitive Behavioral Therapy for Insomnia (Tele-Self-CBTI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705-3875
        • Durham VA Medical Center, Durham, NC

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tele-Self CBTI
Tele-Self CBTi is a telephone-based CBT insomnia intervention
Behavioral: 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
Active Comparator: Health Education Control
The Health Education is an active control arm
Other: 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.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity
Time Frame: Baseline to 8 weeks
Insomnia Severity Index (ISI): The ISI is recommended as the standard for self-reported insomnia symptoms, and will be used as the primary outcome measure. The ISI is a 7-item questionnaire providing a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale and the total score ranges from 0 (no reported symptoms) to 28 (highest insomnia severity symptoms). The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (sub threshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). In clinical samples, a cut off score of 11 was shown to have the greatest sensitivity and specificity for correctly identifying study participants meeting criteria for insomnia diagnosis.
Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Sleep Onset Latency (SOL)
Time Frame: Baseline to 8 week
Sleep Diary sleep onset latency, using the Consensus Sleep Diary (CSD), which is the amount of time asleep in bed divided by the amount of time in bed, averaged across days. The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data will then be averaged across each 2-week assessment period.
Baseline to 8 week
Subjective Wake After Sleep Onset (WASO)
Time Frame: Baseline to 8 week
Sleep Diary WASO, using the Consensus Sleep Diary (CSD). The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data will then be averaged across each 2-week assessment period to determine SOL, WASO and SE.
Baseline to 8 week
Subjective Sleep Efficiency (SE)
Time Frame: Baseline to 8 week
Sleep Diary sleep efficiency, calculated from the Consensus Sleep Diary (CSD), which is the percent of the time asleep out of amount of time spent in bed. The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data are averaged across each 2-week assessment period.
Baseline to 8 week
Objective Wake After Sleep Onset
Time Frame: Baseline to 8 week
Objective WASO using Wrist Actigraphy: The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. WASO is the total number of epochs between the start time and the end time of the given sleep interval scored as wake by Actiware software multiplied by the epoch length in minutes. The investigators will average data across each two-week assessment period. Not all participants completed actigraphy procedures
Baseline to 8 week
Objective Total Sleep Time (TST)
Time Frame: Baseline to 8 week
Objective total sleep time using Wrist Actigraphy: The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. The investigators will average data across each two-week assessment period to determine actigraphy-based WASO, Total Sleep Time (TST) and SE. Not all participants completed actigraphy procedures
Baseline to 8 week
Objective Sleep Efficiency (SE)
Time Frame: Baseline to 8 week
Objective SE using Wrist Actigraphy. The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. SE is the percentage of time spent in bed sleeping, scored total sleep time divided by (interval duration minus total invalid time (sleep/wake)) of the given rest interval multiplied by 100.The investigators will average data across each two-week assessment period.
Baseline to 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Christi S. Ulmer, PhD, Durham VA Medical Center, Durham, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

October 4, 2019

Primary Completion (Actual)

December 16, 2022

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (Actual)

November 1, 2018

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 16-281
  • 1I01HX002350-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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