Clinical trial NCT03688763: A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans
Official title: A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans With Insomnia and Comorbid Psychopathology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: insomnia
anxiety
PTSD
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: Big Health Inc.
First posted: 2018-09-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 or previous diagnosis of sleep apnea that is untreated
* history of moderate or severe Traumatic Brain Injury
* current substance or alcohol use disorder, moderate to severe, in the past 3 months
* current bipolar disorder
* current or lifetime psychotic disorders
* seizure disorders
* moderate to high risk of suicide in the past month

Primary outcomes:
measure: Changes in the Insomnia Severity Index (ISI)
timeFrame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
measure: Changes in Consensus Sleep Diary (CSD)
timeFrame: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up)
measure: Changes in Participant Perception of the Acceptability, Perceived Value, and Feasibility of using a Digital Modality to Treat Insomnia Symptoms
timeFrame: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up)
Secondary outcomes:
measure: Changes in The Posttraumatic Checklist-5 (PCL-5)
timeFrame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
measure: Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9)
timeFrame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
measure: Changes in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
measure: Changes in The Brief Inventory for Psychosocial Functioning (B-IPF)
timeFrame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References: