A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2023-06-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital CBTi administered

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.

Group Type OTHER

Cognitive Behavioral Therapy for Insomnia (CBT-i)

Intervention Type BEHAVIORAL

CBT-i is an evidence-based treatment for insomnia. Participants will receive CBT-i via online program (Sleepio).

Interventions

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Cognitive Behavioral Therapy for Insomnia (CBT-i)

CBT-i is an evidence-based treatment for insomnia. Participants will receive CBT-i via online program (Sleepio).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No