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

Insomnia Disorder Clinical Trial

— Tele-Self CBTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727438
• Other study ID #: IIR 16-281
• Secondary ID: 1I01HX002350-01A
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

The proposed study is 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 for 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. Tele-Self CBTI consists of: 1) Self-management via homework with a workbook, and 2) telephone-based nurse support. Participants will complete 6 weekly readings. The 6 weekly telephone contacts will be 20 minutes through a study nurse. Patients randomized to Health Education Control (HEC) will receive a health education workbook on 6 health topics and 6 weekly phone calls from a study nurse. All participants will continue to receive usual medical care while participating in study. Following completion of the 6 month study, Health Education group participants interested in additional help for their sleep will be referred to the Durham VA Behavioral Sleep Medicine Clinic.

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.The proposed study is a randomized controlled trial comparing Tele-Self CBTI to Health Education Control 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 of subjective (sleep diary) and objective (actigraphy) measures of sleep onset latency (SOL), wakefulness after sleep onset (WASO), and sleep efficiency (SE) 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 a home-based sleep assessment period, a study staff member will conduct study questionnaires over the 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-management via a workbook 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 workbook with the following typical CBTI treatment components: Sleep Restriction; Stimulus Control; Cognitive Therapy; Relaxation; and Sleep Hygiene Education. The investigators will deliver Tele-Self CBTI across 6 weekly telephone contacts of 20 minutes or less through a study nurse. Patients randomized to Health Education Control (HEC) will receive 6 weekly phone calls from a study nurse. Consistent with phone contacts in the intervention arm, HEC phone contacts will last no more than 20 minutes and will match as closely as possible call duration with Tele-Self CBTI participants. Sleep-focused content will be prohibited during HEC calls.

In addition, a qualitative component of the study involves interviewing up to 20 nurses and 5 administrators to assess feasibility of study implementation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: April 1, 2023
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meets diagnostic criteria for Insomnia Disorder

• Receives care through the Durham VAMC or 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 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

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Tele-Self CBTI
The tele-self intervention is comprised of two treatment components: 1) self-management via a workbook with weekly readings, and 2) weekly telephone-based nurse support over 6 weeks

Other:
• Health Education Control
6 weekly phone calls from a study nurse on a range of health topics (non-sleep), similar call duration to intervention phone calls. At the end of the study, participants will be offered assistance through the Durham Behavioral Sleep Medicine clinic.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Ophthalmol Glaucoma. 2022 Jan-Feb;5(1):26-31. doi: 10.1016/j.ogla.2021.05.004. Epub 2021 May — View Citation

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. Ophthalmol Glaucoma. 2022 Jan-Feb;5(1):40-46. doi: 10.1016/j.ogla.2021.04.006. Epub 2021 Apr 20. — View Citation

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 car — View Citation

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 controll — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 0-28. 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 Week 8
Secondary	Subjective Sleep Onset Latency, Wake after Sleep Onset, and Sleep Efficiency	Sleep Diary: The investigators will use the Consensus Sleep Diary (CSD) to assess the impact of Tele-Self CBTI on sleep onset latency (SOL); wake after sleep onset (WASO); and sleep efficiency (SE). An Interactive Voice Response (IVR) approach will be used to collect sleep diary data during each of the three 2-week assessment periods. Diary data will be averaged across each 2-week assessment period to determine diary-based SOL, WASO and SE.	Baseline to Week 8
Secondary	Objective Wake after Sleep Onset, Total Sleep Time, and Sleep Efficiency	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.	Baseline to Week 8