A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans

Palo Alto Veterans Institute for Research

Status: Unknown

Conditions: Insomnia

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03688763

MCC0002ARG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Digital CBTi administered

Other group

Description:

Participants will receive 6 sessions of digitally administered CBTi using the Sleepio platform over the course of 12 weeks. Each session lasts on average 30-60 minutes, and is tailored to participant's progress and problems. During the treatment phase, between sessions, participants complete the Consensus Sleep Diary to track their progress.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i)