Tele-Self CBTI Trial

NCT03727438 | Completed Results

• 2 other identifiers: IIR 16-2811I01HX002350-01A2
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Disorder

Keywords

Cognitive Behavioral Therapy for Insomnia; Self-Directed Treatment; Telehealth

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity

  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 Outcomes (6)

• Subjective Sleep Onset Latency (SOL)

  Baseline to 8 week

• Subjective Wake After Sleep Onset (WASO)

  Baseline to 8 week

• Subjective Sleep Efficiency (SE)

  Baseline to 8 week

• Objective Wake After Sleep Onset

  Baseline to 8 week

• Objective Total Sleep Time (TST)

  Baseline to 8 week

Study Arms (2)

Tele-Self CBTI

EXPERIMENTAL

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

Behavioral: Tele-Self CBTI

Health Education Control

ACTIVE COMPARATOR

The Health Education is an active control arm

Other: Health Education Control

Interventions

Tele-Self CBTI 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

Tele-Self CBTI

Health Education Control 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.

Also known as: Control

Health Education Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Related Publications (3)

• 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.

  PMID: 33688827 BACKGROUND

• 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.

  PMID: 36567058 RESULT

• 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.

  PMID: 39250131 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

Limitations of the study include not achieving equal contact time across conditions and having lower retention of active arm than control condition participants.

Results Point of Contact

• Title: Jennifer Zervakis
• Organization: Department of Veteran Affairs ADAPT

jennifer.zervakis@va.gov

919 286-0411

Study Officials

• Christi S. Ulmer, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 1, 2018
• Study Start: October 4, 2019
• Primary Completion: December 16, 2022
• Study Completion: April 1, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)