A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans

NCT03688763 | Terminated

• 1 other identifier: MCC0002ARG
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

insomnia; anxiety; PTSD

Outcome Measures

Primary Outcomes (3)

• Changes in the Insomnia Severity Index (ISI)

  The ISI is used to assess self-reported insomnia severity (Bastien et al., 2001). It is a 7-item self-report scale assessing sleep problem severity over the last two weeks, rated on a 5-point scale from 0 to 4; a higher score indicates higher severity. The ISI sums scores on the 7 items (1a, 1b, 1c, 2, 3, 4, 5) for a total score range of 0 to 28.

  0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)

• Changes in Consensus Sleep Diary (CSD)

  The CSD (Carney et al., 2012) will be used to monitor self-reported sleep during the baseline phase, over the course of the digitally administered CBT-I intervention, and throughout follow-up. The CSD is a standardized sleep diary based on expert consensus and qualitative patient input.

  12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up)

• Changes in Participant Perception of the Acceptability, Perceived Value, and Feasibility of using a Digital Modality to Treat Insomnia Symptoms

  This unpublished measure requests information on the participants impressions of using digitally administered CBT-i. Questions ask about the following areas: 1) Use of the digitally administered intervention including general impressions and frequency of use, 2) Perceived value and helpfulness of the digitally administered intervention including which features of the program were perceived to be most useful and how the program impacted different aspects of insomnia and management of insomnia, 3) Impact on health (e.g., perceived impact on management of insomnia), 4) Potential enhancements (i.e. recommendations for improvements to the intervention).

  12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up)

Secondary Outcomes (4)

• Changes in The Posttraumatic Checklist-5 (PCL-5)

  0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)

• Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9)

  0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)

• Changes in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)

  0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)

• Changes in The Brief Inventory for Psychosocial Functioning (B-IPF)

  0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)

Study Arms (1)

Digital CBTi administered

OTHER

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.

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

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-i) BEHAVIORAL

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

Digital CBTi administered

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• Big Health Inc.: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: September 28, 2018
• Study Start: February 5, 2018
• Primary Completion: October 24, 2022
• Study Completion: June 21, 2023
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)