TerminatedNot Applicable

A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans

Stopped: Due to COVID-19 related challenges in recruitment and conduct of study, the study was closed.

United States5 participantsStarted 2018-02-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in the Insomnia Severity Index (ISI)

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

Changes in Consensus Sleep Diary (CSD)

Timeframe: 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

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

Trial details

NCT IDNCT03688763

SponsorPalo Alto Veterans Institute for Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-24

View on ClinicalTrials.gov More Insomnia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in the Insomnia Severity Index (ISI)

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

Changes in Consensus Sleep Diary (CSD)

Timeframe: 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

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