An interventional study of Sleep MAPP Care Pathway in Insomnia Disorder and Mild Traumatic Brain Injury, sponsored by VA Office of Research and Development. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
This pilot implementation trial will evaluate the Sleep Disorder Management Assistance for Providers and Patients (Sleep MAPP) Care Pathway in one Veterans Health Administration Polytrauma/TBI System of Care clinic. The care pathway combines a provider-facing decision-support tool that supports pre-visit administration and documentation of the Insomnia Severity Index with training and implementation support for clinic providers to deliver Brief Behavioral Therapy for Insomnia. The study will assess the feasibility and acceptability of the care pathway; describe changes in guideline-concordant insomnia screening and behavioral treatment; and describe preliminary changes in insomnia symptoms, neurobehavioral symptoms, and participation in social roles among Veterans with mild traumatic brain injury who receive Brief Behavioral Therapy for Insomnia. Up to 30 clinic providers or staff and 50 Veterans will be invited to complete research surveys and interviews. Implementation and clinical outcomes will be obtained from routinely collected clinical data.
The Sleep MAPP Care Pathway is a multicomponent implementation strategy designed to improve delivery of guideline-concordant insomnia screening and treatment in the Veterans Health Administration Polytrauma/TBI System of Care.
The first component is the Sleep MAPP decision-support tool. The tool uses existing electronic health record and scheduling information to identify Veterans with upcoming appointments who may be appropriate for insomnia symptom screening, supports electronic administration and documentation of the Insomnia Severity Index, displays screening status and results to the clinical team, and presents guideline-based follow-up options for clinician consideration. Sleep MAPP does not diagnose insomnia disorder, prescribe treatment, or automate clinical decisions. Clinicians independently review the information and make all diagnostic and treatment decisions with the Veteran.
The second component is training and implementation support for Polytrauma/TBI System of Care providers to deliver Brief Behavioral Therapy for Insomnia (BBTI). BBTI is a behavioral intervention that is recommended within clinical practice guidelines as first-line treatment for insomnia disorder. BBTI improves sleep quality by modifying behaviors to enhance and regulate wakefulness, thereby strengthening the homeostatic drive. BBTI also helps structure and optimize sleep and wake times to support and align with the circadian rhythm. The Sleep MAPP Care Pathway includes a pragmatic training process provided to rehabilitation professionals who do not conventionally deliver BBTI. The training is designed to facilitate delivery of BBTI with fidelity, including an intake followed by approximately four treatment sessions focused on stimulus control, sleep restriction, sleep education, adherence problem-solving, and relapse prevention.
The study includes three phases: a 6-month pre-implementation phase, a 12-month implementation phase with active support, and a 6-month post-implementation phase in which active support is withdrawn to assess maintenance.
Aim 1 is designed to evaluate feasibility and acceptability. Up to 30 providers or staff involved in implementation and up to 50 Veterans who received Insomnia Severity Index screening and initiated Brief Behavioral Therapy for Insomnia will complete quantitative assessments and semi-structured interviews. Evaluation of feasibility and acceptability criteria will determine whether the care pathway is ready for larger-scale testing without modification.
Aim 2 is designed to describe change in implementation outcomes after deploying the Sleep MAPP Care Pathway. Outcomes include the reach of Insomnia Severity Index screening and Brief Behavioral Therapy for Insomnia; provider adoption of screening and treatment practices; fidelity to intended care delivery; and maintenance during the post-implementation phase.
Aim 3 describes preliminary clinical changes among Veterans with mild traumatic brain injury who receive BBTI as part of routine care. Insomnia severity, neurobehavioral symptoms, and participation in social roles will be assessed at treatment intake and the final treatment session and abstracted retrospectively from routinely collected clinical data.
The Sleep MAPP Care Pathway will be implemented in the Polytrauma Network Site at the James A. Haley Veterans' Hospital in Tampa, Florida. Rocky Mountain Regional VA Medical Center is the coordinating site. VA Pittsburgh Healthcare System personnel will provide BBTI training and analytic expertise.
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Aim 1 Provider participants (study procedures aimed at understanding feasibility and acceptability)
- Multidisciplinary member of the Polytrauma Network Site who is involved in implementation of the Sleep MAPP Care Pathway (e.g., program leadership, referring clinicians, and clinicians eligible for Brief Behavioral Therapy for Insomnia training).
Aim 1 Veteran participants (study procedures aimed at understanding feasibility and acceptability)
Aim 2 Provider participants (study procedures aimed at understanding reach, adoption, implementation, and maintenance)
- Multidisciplinary member of the Polytrauma Network Site who is involved in implementation of the Sleep MAPP Care Pathway, including referring clinicians and clinicians eligible for Brief Behavioral Therapy for Insomnia training.
Aim 2 Veteran participants (study procedures aimed at understanding reach, adoption, implementation, and maintenance)
Aim 3 Veteran participants (study procedures aimed at understanding change in clinical outcomes after Brief Behavioral Therapy for Insomnia delivery)
Exclusion Criteria:
Does not meet all inclusion criteria.
The participating Polytrauma/TBI System of Care clinic will implement the Sleep MAPP Care Pathway, which is designed to increase delivery of two guideline-recommended clinical practices: insomnia screening with the Insomnia Severity Index and Brief Behavioral Treatment for Insomnia (BBTI). Implementation will be supported by a multicomponent strategy bundle that includes deployment of the Sleep MAPP clinical decision support tool, training providers to deliver BBTI, and complementary implementation supports.
Other: Sleep MAPP Care Pathway
The Sleep MAPP Care Pathway includes four components: (1) the Sleep MAPP clinical decision-support tool, which identifies Veterans who may benefit from insomnia screening and provides clinicians with screening results and care prompts; (2) insomnia screening using the Insomnia Severity Index (ISI); (3) training PNS rehabilitation clinicians to deliver Brief Behavioral Treatment for Insomnia (BBTI); and (4) delivery of BBTI to clinically appropriate Veterans as part of routine care. BBTI is a brief, evidence-based behavioral treatment for insomnia that includes sleep education, stimulus control, sleep restriction, and strategies to support adherence and maintenance of treatment gains.
Provider-rated feasibility of Sleep MAPP decision support tool
Provider respondents complete the four-item Feasibility of Intervention Measure for the Sleep MAPP decision-support tool. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived feasibility.
Time frame: End of the 12-month implementation phase
Provider-rated feasibility of insomnia screening with the Insomnia Severity Index
Provider respondents complete the Feasibility of Intervention Measure for Insomnia Severity Index screening. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived feasibility.
Time frame: End of the 12-month implementation phase
Provider-rated feasibility of Brief Behavioral Therapy for Insomnia (BBTI) training
Provider respondents complete the Feasibility of Intervention Measure for Brief Behavioral Therapy for Insomnia training. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived feasibility.
Time frame: End of the 12-month implementation phase
Provider-rated feasibility of Brief Behavioral Therapy for Insomnia (BBTI)
Provider respondents complete the Feasibility of Intervention Measure for delivery of Brief Behavioral Therapy for Insomnia in routine care. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived feasibility.
Time frame: End of the 12-month implementation phase
Provider-rated acceptability of the Sleep MAPP decision-support tool
Provider respondents complete the Acceptability of Intervention Measure for the Sleep MAPP decision-support tool. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived acceptability.
Time frame: End of the 12-month implementation phase
Provider-rated acceptability of insomnia screening with the Insomnia Severity Index
Provider respondents complete the Acceptability of Intervention Measure for Insomnia Severity Index screening. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived acceptability.
Time frame: End of the 12-month implementation phase
Provider-rated acceptability of Brief Behavioral Therapy for Insomnia (BBTI) training
Provider respondents complete the Acceptability of Intervention Measure for Brief Behavioral Therapy for Insomnia training. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived acceptability.
Time frame: End of the 12-month implementation phase
Provider-rated acceptability of Brief Behavioral Therapy for Insomnia (BBTI) delivery
Provider respondents complete the Acceptability of Intervention Measure for delivery of Brief Behavioral Therapy for Insomnia in routine care. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived acceptability.
Time frame: End of the 12-month implementation phase
Veteran-rated acceptability of insomnia screening using the Insomnia Severity Index
Veterans complete the 8-item Client Satisfaction Questionnaire (CSQ-8) to rate satisfaction with Insomnia Severity Index screening. Items are scored from 1 to 4 and summed to produce a total score ranging from 8 to 32, with higher scores indicating greater satisfaction. The outcome is the percentage of respondents with a mean item score of 3.0 or higher, equivalent to a total score of 24 or higher.
Time frame: Within approximately 1 month after final BBTI session; from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Veteran-rated acceptability of Brief Behavioral Therapy for Insomnia (BBTI)
Veterans complete the 8-item Client Satisfaction Questionnaire (CSQ-8) to rate satisfaction with Brief Behavioral Therapy for Insomnia. Items are scored from 1 to 4 and summed to produce a total score ranging from 8 to 32, with higher scores indicating greater satisfaction. The outcome is the percentage of respondents with a mean item score of 3.0 or higher, equivalent to a total score of 24 or higher.
Time frame: Within approximately 1 month after final BBTI session; from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Feasibility of data collection: Completion rate of Insomnia Severity Index assessments administered through Sleep MAPP
Proportion of pre-visit Insomnia Severity Index assessments administered via Sleep MAPP that were completed by Veterans.
Time frame: From the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Feasibility of data collection: Rate of Insomnia Severity Index score upload to the electronic medical record
Proportion of pre-visit ISI assessments facilitated by Sleep MAPP that were uploaded by providers into the medical record.
Time frame: From the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Feasibility of data collection: Availability of baseline clinical outcome data for Veterans receiving Brief Behavioral Therapy for Insomnia (BBTI)
Proportion of Veterans initiating BBTI who report valid responses for all items on baseline clinical assessments (Insomnia Severity Index; Neurobehavioral Symptom Inventory; PROMIS Satisfaction with Social Roles; PROMIS Ability to Participate in Social Roles).
Time frame: From the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Feasibility of data collection: Availability of follow-up clinical outcome data for Veterans receiving Brief Behavioral Therapy for Insomnia (BBTI)
Proportion of Veterans who engage in a final session of BBTI who report valid responses for all items on follow-up clinical assessments (Insomnia Severity Index; Neurobehavioral Symptom Inventory; PROMIS Satisfaction with Social Roles; PROMIS Ability to Participate in Social Roles).
Time frame: From the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Feasibility of data recruitment/retention: Implementation activity attendance
Proportion of total number of expected attendances of implementation activities (e.g., team meetings) that were actually attended during the pre-implementation and implementation phases. Expected attendance will be calculated by summing the number of eligible team members invited to attend each meeting.
Time frame: From the start of the 6-month pre-implementation phase to the end of the 12-month implementation phase.
Feasibility of recruitment/retention: Initiation of Brief Behavioral Therapy for Insomnia (BBTI) among eligible Veterans
Proportion of eligible Veterans who attend ≥1 BBTI encounter.
Time frame: From the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Feasibility of recruitment/retention: Retention in the Brief Behavioral Therapy for Insomnia (BBTI) protocol
Proportion of Veterans who initiate BBTI who receive ≥3 sessions, reflecting completion of protocol.
Time frame: BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Reach of insomnia screening
Change from pre-implementation to implementation phases in the proportion of eligible Veterans with a scheduled PNS appointment who complete the ISI.
Time frame: Proportion of Veterans who initiate BBTI who receive ≥3 sessions, reflecting completion of protocol.
Reach of Brief Behavioral Therapy for Insomnia (BBTI)
Change from pre-implementation to implementation phases in the proportion of Veterans with probable insomnia (ISI ≥ 11) who receive at least one BBTI encounter.
Time frame: Start of the 6-month pre-implementation phase to the end of the 12-month implementation phase
Adoption of insomnia screening
Proportion of referring clinicians with ≥1 encounter during which a newly completed ISI result is available who document using the ISI result to inform care at least once during the implementation phase.
Time frame: 12-month implementation phase
Adoption of Brief Behavioral Therapy for Insomnia (BBTI): Proportion trained
Proportion of eligible PNS clinicians who complete the BBTI training.
Time frame: 12-month implementation phase
Adoption of BBTI: Proportion delivering Brief Behavioral Therapy for Insomnia (BBTI)
Proportion of trained PNS clinicians who deliver BBTI to at least one Veteran during the implementation phase.
Time frame: 12-month implementation phase
Implementation of insomnia screening
Proportion of a 10% random sample of referring clinician encounter notes with a newly completed ISI result available during which the ISI result is documented as reviewed and used to inform care.
Time frame: 12-month implementation phase
Implementation of Brief Behavioral Therapy for Insomnia (BBTI)
Mean competency score for a 10% random sample of BBTI encounter notes, with higher scores indicating greater proportion of essential treatment components delivered. Notes will be reviewed for documentation of essential treatment components using the BBTI Competency Rating Scale, adapted from the Cognitive Therapy Rating Scale.
Time frame: 12-month implementation phase
Sustained reach of insomnia screening
Proportion of eligible Veterans with a scheduled PNS appointment who complete the ISI during the post-implementation phase. Change from the implementation to post-implementation phases will also be characterized.
Time frame: 6-month post-implementation phase
Sustained reach of Brief Behavioral Therapy for Insomnia (BBTI)
Proportion of Veterans with probable insomnia (ISI ≥ 11) who receive at least one BBTI encounter during the post-implementation phase. Change from the implementation to post-implementation phases will also be characterized.
Time frame: 6-month post-implementation phase.
Sustained adoption of insomnia screening
Proportion of referring clinicians with ≥1 encounter during which a newly completed ISI result is available who document using the ISI result to inform care at least once during the post-implementation phase. Change from the implementation to post-implementation phases will also be characterized.
Time frame: 6-month post-implementation phase.
Sustained adoption of Brief Behavioral Therapy for Insomnia (BBTI)
Proportion of trained PNS providers who remain active and eligible to deliver BBTI and who deliver BBTI to at least one Veteran during the post-implementation phase. Change from the implementation to post-implementation phases will also be characterized.
Time frame: 6-month post-implementation phase.
Sustained implementation of insomnia screening
Proportion of a 10% random sample of referring clinician encounter notes with a newly completed ISI result available during which the ISI result is documented as reviewed and used to inform care during the post-implementation phase. Change from the implementation to post-implementation phases will also be characterized.
Time frame: 6-month post-implementation phase.
Sustained implementation of Brief Behavioral Therapy for Insomnia (BBTI)
Mean competency score for a 10% random sample of BBTI encounter notes, reflecting documented adherence to essential BBTI components during the post-implementation phase. Change from the implementation to post-implementation phases will also be characterized.
Time frame: 6-month post-implementation phase.
Change in Insomnia Severity Index total score
The Insomnia Severity Index is a 7-item measure of insomnia symptoms. Items are rated from 0 to 4 and summed to produce a total score ranging from 0 to 28, with higher scores indicating greater insomnia severity. The outcome is the final-session total score minus the intake total score.
Time frame: BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Insomnia remission based on the Insomnia Severity Index
The Insomnia Severity Index is a 7-item measure of insomnia symptoms, with total scores ranging from 0 to 28 and higher scores indicating greater insomnia severity. The outcome is the percentage of Veterans who completed ≥3 BBTI sessions who report a total score of 7 or lower at the final BBT-I session. A score of 7 or lower indicates remission of clinically significant insomnia symptoms.
Time frame: BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Clinically meaningful insomnia treatment response based on the Insomnia Severity Index
The Insomnia Severity Index is a 7-item measure of insomnia symptoms, with total scores ranging from 0 to 28 and higher scores indicating greater insomnia severity. The outcome is the percentage of Veterans who completed ≥3 BBTI sessions whose Insomnia Severity Index total score decreases by at least 8 points from BBT-I intake to the final BBT-I session. A decrease of at least 8 points indicates a clinically meaningful treatment response.
Time frame: BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Change in Neurobehavioral Symptom Inventory total score
The Neurobehavioral Symptom Inventory contains 22 items rated from 0, indicating no symptoms, to 4, indicating very severe symptoms. Items are summed to produce a total score ranging from 0 to 88, with higher scores indicating more severe neurobehavioral symptoms. The outcome is the final-session total score minus the intake total score. Negative change scores indicate improvement.
Time frame: BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Change in Neurobehavioral Symptom Inventory vestibular domain score
The vestibular domain consists of 3 Neurobehavioral Symptom Inventory items, producing a score ranging from 0 to 12. Higher scores indicate more severe vestibular symptoms. The outcome is the final-session domain score minus the intake domain score. Negative change scores indicate improvement.
Time frame: BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Change in Neurobehavioral Symptom Inventory sensory domain score
The sensory domain consists of 7 Neurobehavioral Symptom Inventory items, producing a score ranging from 0 to 28. Higher scores indicate more severe sensory symptoms. The outcome is the final-session domain score minus the intake domain score. Negative change scores indicate improvement.
Time frame: BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Change in Neurobehavioral Symptom Inventory mood-behavioral domain score
The mood-behavioral domain consists of 6 Neurobehavioral Symptom Inventory items, producing a score ranging from 0 to 24. Higher scores indicate more severe mood-behavioral symptoms. The outcome is the final-session domain score minus the intake domain score. Negative change scores indicate improvement.
Time frame: BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Change in Neurobehavioral Symptom Inventory cognitive domain score
The cognitive domain consists of 4 Neurobehavioral Symptom Inventory items, producing a score ranging from 0 to 16. Higher scores indicate more severe cognitive symptoms. The outcome is the final-session domain score minus the intake domain score. Negative change scores indicate improvement.
Time frame: BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Change in PROMIS Satisfaction with Social Roles and Activities 8-item T-score
The 8-item PROMIS Satisfaction with Social Roles and Activities measure assesses satisfaction with performing usual social roles and activities. Raw scores will be converted to standardized T-scores, with a reference-population mean of 50 and standard deviation of 10. Higher T-scores indicate greater satisfaction. The outcome is the final-session T-score minus the intake T-score. Positive change scores indicate improvement.
Time frame: BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Change in PROMIS Ability to Participate in Social Roles and Activities 8-item T-score
The 8-item PROMIS Ability to Participate in Social Roles and Activities measure assesses perceived ability to participate in usual social roles and activities. Raw scores will be converted to standardized T-scores, with a reference-population mean of 50 and standard deviation of 10. Higher T-scores indicate greater ability to participate. The outcome is the final-session T-score minus the intake T-score. Positive change scores indicate improvement.
Time frame: BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.
Plan to share: No — Individual participant data will not be made publicly available because the study uses Veterans Health Administration electronic health record data and qualitative data that may contain sensitive or potentially identifiable information. Data access and sharing will follow applicable Department of Veterans Affairs privacy, security, regulatory, and data-use requirements. Aggregate results will be disseminated through ClinicalTrials.gov and scientific publications.
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