Telemedicine Management of Chronic Insomnia

Objectives(s): The investigators are conducting a randomized, controlled trial of Veterans
with PTSD and chronic insomnia to determine if cognitive behavioral therapy for insomnia
(CBT-I) administered by video teleconferencing is not clinically inferior to in-person
treatment in terms of improvement in insomnia symptoms. Secondary aims are 1) comparing the
differences in cost and quality-adjusted life years between the treatment delivery
approaches and 2) determining the effectiveness of CBT-I on functional outcomes, sleep
quality, and non-sleep-related PTSD symptoms. The investigators are also conducting a
patient- and provider-focused formative evaluation of CBT-I delivery by video
teleconferencing to assess potential barriers to its widespread implementation.

Research Design: This prospective randomized controlled non-inferiority study will determine
if Veterans with PTSD and chronic insomnia receiving CBT-I by video teleconferencing have an
improvement in insomnia severity, as determined by change in Insomnia Severity Index (ISI)
score, that is not clinically inferior to that in Veterans receiving in-person CBT-I.
Differences in cost and quality-adjusted life years (QALY) between groups will also be
compared.

Methodology: Veterans with PTSD and chronic insomnia receiving their primary care at
community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC are be
randomized to receive one of the following interventions in a group setting at their CBOC:
1) a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program
delivered in-person, and 3) in-person delivery of sleep hygiene education, a known active
control intervention. Participants are assessed at baseline, and 2 weeks and every 3 months
following the intervention. The primary outcome measure in Aim 1 is the change in the
Insomnia Severity Index (ISI) score at 6 months following intervention. Non-inferiority
analysis will be used to compare the effectiveness of the two delivery methods, with a
pre-specified margin. Results will be ascertained via intent to treat and per-protocol
procedures. The investigators hypothesize that the change in ISI score following CBT-I by
video teleconferencing will not be clinically inferior to that following in-person delivery.
In Aim 2, VA and non-VA total healthcare costs are being collected to test whether average
cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care.
Preference is being assessed by the EuroQol and Health Utilities Index 2. Differences in the
ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing
and in-person encounter will be compared to test the hypothesis that video teleconferencing
will have lower cost and equivalent outcomes. Aim 3 is assessing the effect of CBT-I on
functional outcomes (Short Form-12, Work and Social Adjustment Scale), sleep quality
(Pittsburgh Sleep Quality Index, sleep diary and wrist actigraphy), and PTSD severity (the
non-sleep component of the PTSD Checklist-Military). The investigators hypothesize that
these functional outcomes and sleep quality measures will improve following each method of
CBT-I delivery and that CBT-I will improve non-sleep-related PTSD severity. The formative
evaluation of the telemedicine delivery of CBT-I in Aim 4 is using qualitative (targeted
focus groups with participants and therapist interviews) and quantitative measures (Work
Alliance Inventory, Treatment Credibility Scale, attrition) that will help guide future
implementation of CBT-I by video teleconferencing

Anticipated Findings: The investigators believe these results will demonstrate that: 1)
Veterans in both CBT-I groups will have similar improvement in functional outcomes, and 2)
treatment delivery by video teleconferencing will be more cost effective than in-person
care. These findings should lead to wider acceptance of video teleconferencing, thereby
increasing patient access to care and reducing treatment costs.

Inclusion Criteria:

Veterans will have to meet the following inclusion criteria in order to be enrolled in
this RCT:

- Men and women at least 18 years of age.

- Meet current DSM-IV-TR criteria for PTSD as determined by the Clinician Administered
PTSD Scale (CAPS)

- Insomnia Severity Index score > 14, the commonly used threshold for clinical
insomnia, with self-reported duration of insomnia >6 months.

- Ability to read and speak English (assessment instruments and therapy will be
available only in English)

Exclusion Criteria:

Veterans will be excluded from participation if they meet any of the following exclusion
criteria:

- Unable or unwilling to provide informed consent.

- Unwilling to participate in supervised group sessions at the community based
outpatient clinic

- No telephone access or inability to return for follow-up testing.

- Individuals with an untreated sleep disorder [e.g., obstructive sleep apnea
(apnea-hypopnea index 15 events/hr), periodic limb movement disorder (10 leg
movements/hr of sleep with arousals), central sleep apnea ( 50% of apneas are
central), Cheyne-Stokes respiration, obesity hypoventilation syndrome, and
narcolepsy].

- A clinically unstable medical condition as defined by a new diagnosis or change in
medical management in the previous 2 months.

- Evidence of substance dependence during the preceding twelve months. Evidence of "at
risk" drinking behavior over the past month. Namely for men: more than 4 drinks on a
given night, drinking on more than 3 nights a week, or more than 14 total drinks in a
week; for women: more than 3 drinks in a given night, drinking on more than 3 nights
a week, or more than 7 total drinks in a week.

- Individuals with bipolar disorder, delirium, dementia, amnestic disorder,
schizophrenia and other psychotic disorders as determined by the SCID questionnaire.
A concurrent anxiety disorder or depressive disorder diagnosis will be allowed.

- Individuals with prominent current suicidal or homicidal ideation. This will be
assessed by the clinical psychologist administering the SCID and CAPS. In cases of
prominent current suicidal or homicidal ideation appropriate safety measures will be
taken. Following stabilization, Veterans who continue to be interested in
participating in the study may be re-assessed.

- Unable to perform tests due to inability to communicate verbally, inability to read
and write; less than a 5th grade reading level; visual, hearing or cognitive
impairment (e.g., previous head injury).