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

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ClinicalTrials.gov Identifier: NCT03727438
Recruitment Status : Enrolling by invitation
First Posted : November 1, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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 will be offered either face to face group-based treatment or Tele-Self CBTI treatment through our 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 self-report 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.


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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 : December 1, 2021
Estimated Study Completion Date : May 1, 2022

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




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.



Information from the National Library of Medicine

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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

Exclusion Criteria:

  • Moderate to 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
  • Positive screen for sleep apnea without prior diagnosis
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727438


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

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03727438     History of Changes
Other Study ID Numbers: IIR 16-281
1I01HX002350-01A2 ( U.S. NIH Grant/Contract )
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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