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

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, 6 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.