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

• ClinicalTrials.gov Identifier: NCT03727438
• Recruitment Status: Enrolling by invitation
• First Posted: November 1, 2018
• Last Update Posted: December 10, 2021
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

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.

Condition or disease	Intervention/treatment	Phase
Insomnia Disorder	Behavioral: Tele-Self CBTI; Other: Health Education Control	Not Applicable

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.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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Provider Supported Self-Help Cognitive Behavioral Therapy for Insomnia (Tele-Self-CBTI)
• Actual Study Start Date: September 17, 2019
• Estimated Primary Completion Date: April 30, 2022
• Estimated Study Completion Date: December 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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
Active Comparator: 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.	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.; Other Name: Control

Outcome Measures

Primary Outcome Measures :

1. Insomnia Severity [ Time Frame: Baseline to Week 8 ]
   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.

Secondary Outcome Measures :

1. Subjective Sleep Onset Latency, Wake after Sleep Onset, and Sleep Efficiency [ Time Frame: Baseline to Week 8 ]
   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.
2. Objective Wake after Sleep Onset, Total Sleep Time, and Sleep Efficiency [ Time Frame: Baseline to Week 8 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, North Carolina

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705

United States, Utah

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, United States, 84148

United States, Wisconsin

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States, 53705

Sponsors and Collaborators

VA Office of Research and Development

Investigators

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

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03727438
• Other Study ID Numbers: IIR 16-281; 1I01HX002350-01A2 ( U.S. NIH Grant/Contract )
• First Posted: November 1, 2018
• Last Update Posted: December 10, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by VA Office of Research and Development:

Cognitive Behavioral Therapy for Insomnia; Self-Management; Telehealth

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders