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Table 1 Inclusion and exclusion criteria

From: A hybrid type I trial to increase Veterans’ access to insomnia care: study protocol for a randomized controlled trial

Inclusion criteria

 Military Veteran

 Age ≥ 18 years

 ISI ≥ 15 (moderately severe insomnia) and DSM-5 criteria for insomnia disorder

Exclusion criteria

 Current/past bipolar disorder or seizure disorder, and current psychotic disorder in order to avoid potential exacerbation of manic/hypomanic, seizure, and psychotic symptoms, respectively, as adverse reactions to aspects of BBTI/CBTI (e.g., sleep restriction)

 Current alcohol use disorder or substance use disorder as BBTI/CBTI cannot reverse the adverse effects of substances on sleep

 Other current, severe or unstable, psychiatric and medical disorders that necessitate clinical management that can confound results (e.g., cancer [receiving chemotherapy], suicidality, recent hospitalization [medical/surgical] for which recovery overlaps with study onset and duration, open skull/brain injury, moderate to severe traumatic brain injury)

 Previously diagnosed sleep apnea that is not adequately treated or probable sleep apnea (STOP-BANG ≥ 5)

 Moderate to severe cognitive impairment (SLUMS ≤ 20) and/or diagnosis in the medical record indicative of moderate-to-severe cognitive impairment

 If using a sleep medication, the medication and dose has changed in the past month and/or is expected to change during the treatment phase of the study

 If using other psychotropic medication, medication and dose has changed in the past 2 months and/or are expected to change during the treatment phase of the study

 The following are exclusionary as they represent (potentially) temporary states/situations that may significantly impair normal sleep:

 Women who are pregnant and/or breast feeding

 Unstable environment that is not in one’s control (e.g., homeless, temporary group home, care-taking duties at night)

 Shift work: severe delayed sleep phase disorder (e.g., habitual bedtime after 4 a.m. or habitual rise time after 11 a.m.)

 Restless leg syndrome with symptoms > 2 times per week and causing significant distress

  1. BBTI Brief Behavioral Treatment for Insomnia, CBTI Cognitive Behavioral Therapy for Insomnia, DSM Diagnostic and Statistical Manual of Mental Disorders, ISI Insomnia Severity Index, SLUMS St. Louis University Mental Status Examination