A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans



Status:Not yet recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:9/30/2018
Start Date:September 2018
End Date:January 2020
Contact:Shannon McCaslin-Rodrigo, Ph.D.
Email:Shannon.McCaslin@va.gov
Phone:650/493-5000

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A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans With Insomnia and Comorbid Psychopathology

The proposed study is a multiple baseline design pilot study which seeks to evaluate the
impact of digitally administered CBT-I, using the Sleepio platform, for the treatment of
insomnia disorder among Veterans with co-morbid psychopathology. In addition, information
related to acceptability and feasibility of the intervention among a Veteran sample will be
obtained.

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered the front-line intervention
for individuals with insomnia and has recently been rolled-out throughout the Veterans Health
Administration (VHA; Manber et al., 2012). CBT-I includes behavioral (sleep restriction,
stimulus control, relaxation exercises), cognitive (cognitive restructuring, mindfulness
exercise), and psychoeducation (sleep hygiene) components. While CBT-I has been demonstrated
to be a highly efficacious and effective intervention, it is a specialized intervention that
can be costly and is in limited supply based on the level of training required and number of
providers available. For this reason, digital administration of CBT-I has been examined and
research has demonstrated initial efficacy among community samples (Ritterband et al., 2009;
Vincent et al., 2009; Espie et al., 2012), with one platform, Sleepio, demonstrating efficacy
compared to a placebo intervention (Espie et al., 2012; Espie et al., 2014). For this reason,
the current study will utilize the Sleepio platform which provides an interactive, customized
and tailored delivery of CBT-I.

Inclusion Criteria:

Participants must be:

- at least 18 years of age (no upper age limit)

- meet DSM-5 defined criteria for insomnia disorder

- be on a stable dose of any prescription medication (including sleep medication) for at
least 2 weeks prior to the in-person screening assessment

- have comorbid psychopathology (i.e., symptoms of Posttraumatic Stress Disorder (PTSD),
anxiety, and/or depression)

Exclusion Criteria:

- limited mental competency (not oriented to person, place, or time) and the inability
to give informed, voluntary, or written consent to participate

- high risk for sleep apnea (STOP-Bang score >/= 3)

- current bipolar disorder

- current or lifetime psychotic disorders

- seizure disorders

- active suicidal ideation
We found this trial at
1
site
3801 Miranda Avenue
Palo Alto, California 94304
650-493-5000
VA Palo Alto Health Care System The VA Palo Alto Health Care System (VAPAHCS) consists...
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mi
from
Palo Alto, CA
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