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Implementation of Brief Insomnia Treatments - Clinical Trial (iBIT)

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ClinicalTrials.gov Identifier: NCT02724800
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Adam Bramoweth, VA Pittsburgh Healthcare System

Brief Summary:
The purpose of this study is to directly compare the effectiveness of two interventions for insomnia: Brief Behavioral Treatment for Insomnia (BBTI) vs. Cognitive Behavioral Therapy for Insomnia (CBTI).

Condition or disease Intervention/treatment Phase
Chronic Insomnia Behavioral: CBTI Behavioral: BBTI Not Applicable

Detailed Description:

Cognitive Behavioral Therapy for Insomnia (CBTI) is the evidence-based first line treatment for chronic insomnia. Randomized controlled trials and meta-analyses have established that CBTI is efficacious and effective. Despite the strong evidence for CBTI, chronic insomnia remains under-treated among Veterans because of several barriers that limit access to behavioral treatments. In recent years, the VA has taken substantial measures to train more clinicians to provide insomnia treatment; however, a deficit in treatment availability remains. In 2011, the VA began to train clinicians in CBTI as part of the VA's Evidence Based Psychotherapy (EBP) training program, with a goal to train 1000 clinicians. Even with 1000 VA clinicians trained in CBTI, a shortage of clinicians will likely remain due to the high prevalence of insomnia. High prevalence and a shortage of clinicians prevent the VA from meeting the care demand of Veterans with insomnia. While the CBTI roll-out is a significant investment from the VA, additional mechanisms, such as dissemination and implementation of other evidence-based treatments for insomnia with fewer implementation barriers, must be considered to address the high prevalence of insomnia.

The in-person delivery and length of treatment for CBTI may be one of barriers to accessing care. Briefer protocols that use multiple delivery modalities have recently been developed and may help to increase session attendance and treatment completion. These shorter insomnia treatments are often referred to as Brief Behavioral Treatment for Insomnia (BBTI) and consist of ≤4 sessions. Besides fewer and briefer sessions, and utilizing both in-person and phone delivery of treatment, BBTI also emphasizes the behavioral components of CBTI (i.e., stimulus control and sleep restriction) rather than a combined approach focusing on both behavioral and cognitive components. BBTI is efficacious in adults—studies with older adults and Veterans found BBTI resulted in a significant decrease in insomnia severity with Cohen's d effect sizes in the moderate to large range. Like CBTI, BBTI significantly improves insomnia severity and may also help to improve secondary outcomes like depression and anxiety.

Integration of newer insomnia treatments, like BBTI, will first depend on establishing its evidence directly compared to CBTI. Effectiveness trials of BBTI, especially those conducted with military Veterans in typical VA settings, have yet to be conducted. Before BBTI can be broadly implemented and integrated into the VA, it needs to be established as a clinically effective treatment for insomnia among Veterans and a statistically non-inferior treatment (not necessarily better or worse) for Veterans compared to CBTI.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : April 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Active Comparator: CBTI
CBTI consists of five in-person sessions within an eight week period. Topics covered include: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene.
Behavioral: CBTI
48 Veterans with chronic insomnia will be randomized to CBTI. The intervention will be delivered in 5 face-to-face session within an 8 week time period. The intervention will be delivered at the VA Pittsburgh Healthcare System. Treatment visits will last approximately 45 minutes.
Other Name: Cognitive Behavioral Therapy for Insomnia

Active Comparator: BBTI
BBTI consists of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered include: sleep education, stimulus control, and sleep restriction.
Behavioral: BBTI
48 Veterans with chronic insomnia will be randomized to BBTI. The intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3 (option for telephone), and telephone appointments on Weeks 2 and 4. Interventions will be delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit is approximately 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes. Brief (<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.
Other Name: Brief Behavioral Treatment for Insomnia




Primary Outcome Measures :
  1. Insomnia symptom change: Insomnia Severity Index (ISI) [ Time Frame: change from: (1) baseline to post-treatment (BBTI: week 5; CBTI: week 6-9); (2) baseline to 3-month follow-up (BBTI: week 17; CBTI: week 18-21); (3) baseline to 12-month follow-up (BBTI: week 57; CBTI: week 58-61) ]

Secondary Outcome Measures :
  1. Depression symptom change: Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: change from: (1) baseline to post-treatment (BBTI: week 5; CBTI: week 6-9); (2) baseline to 3-month follow-up (BBTI: week 17; CBTI: week 18-21); (3) baseline to 12-month follow-up (BBTI: week 57; CBTI: week 58-61) ]
  2. Anxiety symptom change: Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: change from: (1) baseline to post-treatment (BBTI: week 5; CBTI: week 6-9); (2) baseline to 3-month follow-up (BBTI: week 17; CBTI: week 18-21); (3) baseline to 12-month follow-up (BBTI: week 57; CBTI: week 58-61) ]
  3. Posttraumatic Stress Disorder (PTSD) symptom change: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) (PCL-5) [ Time Frame: change from: (1) baseline to post-treatment (BBTI: week 5; CBTI: week 6-9); (2) baseline to 3-month follow-up (BBTI: week 17; CBTI: week 18-21); (3) baseline to 12-month follow-up (BBTI: week 57; CBTI: week 58-61) ]
  4. Fatigue symptom change: Patient Reported Outcome Measurement System (PROMIS) Fatigue Scale [ Time Frame: change from: (1) baseline to post-treatment (BBTI: week 5; CBTI: week 6-9); (2) baseline to 3-month follow-up (BBTI: week 17; CBTI: week 18-21); (3) baseline to 12-month follow-up (BBTI: week 57; CBTI: week 58-61) ]
  5. Quality of Life change: PROMIS Global Health [ Time Frame: change from: (1) baseline to post-treatment (BBTI: week 5; CBTI: week 6-9); (2) baseline to 3-month follow-up (BBTI: week 17; CBTI: week 18-21); (3) baseline to 12-month follow-up (BBTI: week 57; CBTI: week 58-61) ]
  6. Psychosocial Functioning change: Work and Social Adjustment Scale (WSAS) [ Time Frame: change from: (1) baseline to post-treatment (BBTI: week 5; CBTI: week 6-9); (2) baseline to 3-month follow-up (BBTI: week 17; CBTI: week 18-21); (3) baseline to 12-month follow-up (BBTI: week 57; CBTI: week 58-61) ]
  7. Sleep Behavior change: Sleep Diary [ Time Frame: change from: (1) baseline to post-treatment (BBTI: week 5; CBTI: week 6-9); (2) baseline to 3-month follow-up (BBTI: week 17; CBTI: week 18-21); (3) baseline to 12-month follow-up (BBTI: week 57; CBTI: week 58-61) ]
  8. Sleep Quality change: Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: change from: (1) baseline to post-treatment (BBTI: week 5; CBTI: week 6-9); (2) baseline to 3-month follow-up (BBTI: week 17; CBTI: week 18-21); (3) baseline to 12-month follow-up (BBTI: week 57; CBTI: week 58-61) ]
  9. Daytime Sleepiness change: Epworth Sleepiness Scale (ESS) [ Time Frame: change from: (1) baseline to post-treatment (BBTI: week 5; CBTI: week 6-9); (2) baseline to 3-month follow-up (BBTI: week 17; CBTI: week 18-21); (3) baseline to 12-month follow-up (BBTI: week 57; CBTI: week 58-61) ]
  10. Sleep Beliefs change: Dysfunctional Beliefs and Attitudes About Sleep (DBAS) [ Time Frame: change from: (1) baseline to post-treatment (BBTI: week 5; CBTI: week 6-9); (2) baseline to 3-month follow-up (BBTI: week 17; CBTI: week 18-21); (3) baseline to 12-month follow-up (BBTI: week 57; CBTI: week 58-61) ]


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:

  1. Age 18 years old and older
  2. Military Veteran
  3. Insomnia Severity Index (ISI) ≥15 & DSM-5 criteria for insomnia disorder
  4. If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)
  5. If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)

Exclusion Criteria:

  1. Untreated, current, and severe PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID)
  2. Untreated, current, and severe Major Depressive Disorder as determined by the SCID
  3. Current/Past Psychotic or Bipolar disorder
  4. Current substance or alcohol use disorder as determined by the SCID
  5. Current unstable medical condition
  6. Hospitalization in the previous 1 month for a medical condition or surgery for which recovery overlaps with the study onset and duration
  7. Seizure disorder, open skull brain injury, or moderate to severe traumatic brain injury (TBI)
  8. Current, untreated, sleep disorders such as nightmare disorder, restless legs syndrome, circadian rhythm disorder (or shift work), or a suspected sleep disorder requiring polysomnographic assessment, such as obstructive sleep apnea or periodic leg movements as determined by the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) Clinical Interview for DSM-5 Sleep-Wake Disorders and/or the STOP-BANG questionnaire
  9. Moderate to severe cognitive impairment (St. Louis University Mental Status [SLUMS] exam ≤20) and/or diagnosis in medical record indicative of moderate to severe cognitive impairment
  10. Unstable environment that is not in one's control (e.g., homeless, temporary group home, care taking duties at night)
  11. Pregnancy and/or breast-feeding

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): NCT02724800


Contacts
Contact: Adam D Bramoweth, PhD 412-360-2806 Adam.Bramoweth@va.gov

Locations
United States, Pennsylvania
VA Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Lisa Lederer, MS    412-360-2364    Lisa.Lederer@va.gov   
Principal Investigator: Adam D Bramoweth, PhD         
Sponsors and Collaborators
VA Pittsburgh Healthcare System
VA Office of Research and Development

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adam Bramoweth, Research Health Scientist, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT02724800     History of Changes
Other Study ID Numbers: Pro00001553
1IK2HX001548-01A2 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Adam Bramoweth, VA Pittsburgh Healthcare System:
Insomnia
Veterans
Cognitive Behavioral Therapy for Insomnia
Brief Behavioral Treatment for Insomnia
Comparative Effectiveness Research

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders