InsomniaNCT03688763
A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-i) in people with Insomnia, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-i)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 21 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- current or lifetime psychotic disorders
- seizure disorders
- moderate to high risk of suicide in the past month
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans With Insomnia and Comorbid Psychopathology
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.
Read the detailed 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.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-i)
- Keywords
- insomnia, anxiety, PTSD
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-i)Behavioural
CBT-i is an evidence-based treatment for insomnia. Participants will receive CBT-i via online program (Sleepio).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up)
Secondary outcomes (4)
Changes in The Posttraumatic Checklist-5 (PCL-5)
The PCL-5 is a self-report measure of PTSD symptom severity (Weathers et al., 2013). The PCL is a 20-item measure which asks respondents how much they had been bothered in the prior month by their most traumatic experience. Item responses range from 0 (not very much) to 4 (extremely) with a total score range is 0-80. DSM-5 symptom cluster scores sum item scores: Cluster B (items 1-5), C (6-7), D (8-14), and E (items 15-20).
Measured: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9)
The PHQ-9 is a 9-item self-report scale assessing depression over the last two weeks (Kroenke et al., 2002). An additional item asking about global depression and interference with life activities is not included in the PHQ-9 score. Items are scored from 0 (not at all) to 3 (nearly every day), for a total score range of 0 to 27.
Measured: 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)
The GAD-7 is a 7-item anxiety scale (Spitzer et al., 2006) assessing symptoms over the past two weeks. Item scores range from 0 (not at all) to 3 (nearly every day). Items are summed to yield a total score.
Measured: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
Changes in The Brief Inventory for Psychosocial Functioning (B-IPF)
The B-IPF-7 is a 7-item measure scored from 0 (not at all) to 6 (very much) (Bovin et al., 2018). The total score is the mean of the sum of all 7 items. The B-IPF assesses social functioning, academic and occupational functioning, daily activities over the past 30 days.
Measured: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start5 Feb 2018
- Primary completion24 Oct 2022
- Study completion21 Jun 2023
Why it stopped: Due to COVID-19 related challenges in recruitment and conduct of study, the study was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- Big Health Inc.
- Responsible party
- Principal investigator, Shannon McCaslin, Palo Alto Veterans Institute for Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688763
- Sponsor's protocol ID
- MCC0002ARG
- Status last verified
- Aug 2025
- First submitted
- 3 Apr 2018
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans With Insomnia and Comorbid Psychopathology
- ClinicalTrials.gov ID
- NCT03688763
- Acronym / sponsor ID
- MCC0002ARG
- Conditions
- Insomnia
- Keywords
- insomnia, anxiety, PTSD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 related challenges in recruitment and conduct of study, the study was closed.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- Big Health Inc.
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital CBTi administered | Other | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Digital CBTi administered |
Primary outcome
Changes in the Insomnia Severity Index (ISI)
Time frame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
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.
Changes in Consensus Sleep Diary (CSD)
Time frame: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up)
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.
Changes in Participant Perception of the Acceptability, Perceived Value, and Feasibility of using a Digital Modality to Treat Insomnia Symptoms
Time frame: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up)
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).
4 secondary outcomes
Changes in The Posttraumatic Checklist-5 (PCL-5)
Time frame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9)
Time frame: 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)
Time frame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
Changes in The Brief Inventory for Psychosocial Functioning (B-IPF)
Time frame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
Results and safety
The study was stopped early (reason given: Due to COVID-19 related challenges in recruitment and conduct of study, the study was closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-i) in people with Insomnia, run by Palo Alto Veterans Institute for Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID-19 related challenges in recruitment and conduct of study, the study was closed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Insomnia Severity Index (ISI) (time frame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.