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IIR 16-281 – HSR Study

IIR 16-281
Provider Supported Self-Help Cognitive Behavioral Therapy for Insomnia (Tele-Self-CBTI)
Christi S. Ulmer, PhD
Durham VA Medical Center, Durham, NC
Durham, NC
Funding Period: November 2018 - April 2023


Anticipated Impacts on Veteran’s Healthcare: Insomnia is pervasive among Veterans and is a risk factor for the most common mental health problems treated in the VA healthcare system, including depression, PTSD, and suicidality. A provider-supported Self-management strategy for insomnia can bridge the gap between unavailable resources and high demand for services, and has the potential to improve outcomes across multiple life domains. Project Background/Rationale: Cognitive Behavioral Therapy for Insomnia (CBTI) is a multi-component insomnia intervention that is recommended as the first-line insomnia treatment. Yet, Veteran access to CBTI is limited by a number of factors, including an inadequate number of trained providers for the high prevalence of insomnia among Veterans, the inconvenience of weekly treatment offered exclusively in a clinical setting, and the distance to VA facilities among rural Veterans. Self-management CBTI is effective in treating insomnia among those without significant medical and mental health co-morbidities, and requires fewer provider resources. As such, Self-management CBTI is a viable option for increasing Veteran access to CBTI. Project Objectives: The proposed study will examine two primary research questions, and one exploratory research question: 1. Does Tele-Self CBTI result in reduced insomnia severity among Veterans with Insomnia Disorder? Primary Hypothesis: (H1) Relative to Health Education, participants randomized to receive Tele-Self CBTI will have greater improvements in insomnia severity, as measured by the Insomnia Severity Index (ISI) at 6 weeks. 2. Does Tele-Self CBTI result in improvements in subjectively and objectively assessed sleep, fatigue, depression symptoms, and quality of life (QOL)? Secondary Hypotheses: (H2) Relative to Health Education, participants randomized to receive Tele-Self CBTI will have greater improvements in subjective sleep (per diary sleep onset latency, wake after sleep onset, and sleep efficiency), objective sleep (per actigraphy wake after sleep onset, total sleep time, and sleep efficiency), fatigue, depression symptoms, and QOL at 6 weeks. 3. How do nurses and administrators perceive Tele-Self CBTI in terms of the feasibility and acceptability of implementing this intervention in the primary care setting? No hypotheses are proposed for this exploratory research question. Project Methods: Study participants (200) will be randomly assigned in equal proportions to either the Tele- Self CBTI intervention, or to Health Education. A multi-modal assessment strategy will be used to assess insomnia severity, sleep parameters, fatigue, depression symptoms, and quality of life across 3 time points: baseline, 6 weeks (primary endpoint), and 6 months. In addition, we will interview nurses and clinic administrators about Tele-Self CBTI to inform future efforts to implement and disseminate the intervention in the primary care clinical setting, if Tele-Self CBTI is found to be effective.

External Links for this Project

NIH Reporter

Grant Number: I01HX002350-01A2

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Journal Articles

  1. Kang JM, Chatterjee A, Rosdahl JA, Bosworth HB, Woolson S, Olsen M, Sexton M, Kirshner M, Muir KW. Health Literacy and Success with Glaucoma Drop Administration. Ophthalmology. Glaucoma. 2022 Jan 1; 5(1):26-31. [view]
  2. Muir KW, Rosdahl JA, Hein AM, Woolson S, Olsen MK, Kirshner M, Sexton M, Bosworth HB. Improved Glaucoma Medication Adherence in a Randomized Controlled Trial. Ophthalmology. Glaucoma. 2022 Jan 1; 5(1):40-46. [view]
  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. Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine. 2021 Jul 1; 17(7):1441-1446. [view]
  4. 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. Contemporary clinical trials. 2023 Feb 1; 125:107060. [view]
  5. Rosdahl JA, Hein AM, Bosworth HB, Woolson S, Olsen M, Kirshner M, Hung A, Muir KW. Randomized controlled trial of an education-based intervention to improve medication adherence: Design considerations in the medication adherence in glaucoma to improve care study. Clinical trials (London, England). 2021 Jun 1; 18(3):343-350. [view]

DRA: Mental, Cognitive and Behavioral Disorders
DRE: TRL - Applied/Translational, Treatment - Comparative Effectiveness
Keywords: Cognitive Therapy, Comparative Effectiveness, Implementation
MeSH Terms: None at this time.

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