A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans With Insomnia and Comorbid Psychopathology
Cognitive Behavioral Therapy for Insomnia (CBT-i)
Trauma and Stressor Related Disorders+7
+ Anxiety Disorders
+ Mental Disorders
Treatment Study
Summary
Study start date: February 5, 2018
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
VA Palo Alto Health Care System
Palo Alto, United StatesOpen VA Palo Alto Health Care System in Google Maps