InsomniaNCT05814783
Clinician Training Program to Integrate Digital CBTI Into Routine Psychotherapy
A study testing supported digital CBTI and digital CBTI in people with Insomnia, run by Stanford University at 1 site in United States.
Trial summary
The goal of this study is to pilot test and refine a training program for licensed therapists to promote the integration of digital cognitive behavior therapy for insomnia (dCBTi) into their routine mental health care services. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- supported digital CBTI and digital CBTI
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2023to 26 Jan 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Licensed mental health clinicians
- Have a clinical care model that includes seeing patients weekly or biweekly
- Provide therapy in English
- Treat patients with depression and/or anxiety
- Can identify 1-2 patients who are willing to consent to be training cases.
- Aged 18+ years old
Show all 10Show fewer
- Receive weekly or biweekly therapy from participating study therapist
- Identify improving sleep as a goal for treatment and experience insomnia (Insomnia Severity Index score greater than or equal to 10)
- Have daily access to a smartphone, tablet, or computer
- Can read, write, and speak in English
Who cannot join
- Not meeting all of the inclusion criteria
- Patient Criteria:
- Conditions known to make study treatment less effective (e.g., current chronic medication use known to interfere with sleep, alcohol or substance use disorder, thought disorder)
- Conditions for which dCBTi is a safety risk (e.g., bipolar disorder, excessive daytime sleepiness)
- Current psychotherapy for insomnia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinician Training Program to Integrate Digital Cognitive Behavior Therapy for Insomnia Into Routine Psychotherapy
The goal of this study is to pilot test and refine a training program for licensed therapists to promote the integration of digital cognitive behavior therapy for insomnia (dCBTi) into their routine mental health care services.
- Conditions
- Insomnia
- Being tested
- supported digital CBTI, digital CBTI
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supported digital CBTIBehavioural
in session support for adherence to and engagement with digital CBTI
digital CBTIDevice
CBTI app
| Study group | Role | What they receive |
|---|---|---|
| Integrated digital CBTI | Experimental | Therapists will be trained to integrate digital CBTI alongside routine psychotherapy. Patients will receive integrated digital CBTI Receives: Behavioral: supported digital CBTI; Device: digital CBTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI)
Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity, patient outcome.
Measured: Pre-treatment and immediately post-treatment (treatment phase is 12 weeks)
Change in Knowledge of Supporting Integrated dCBTi
Therapist outcome assessing knowledge gained during training program measured via a study-specific questionnaire on which higher scores indicating more knowledge
Measured: Pre-training (at the start of the one day training) and immediately post-training (at the end of the one day training)
Secondary outcomes (1)
Time spent supporting dCBTi
From a structured post-session note completed by the therapist, therapist-reported how much time spent devoted to supporting dCBTI
Measured: Through study duration, usually 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start24 Aug 2023
- Primary completion26 Jan 2025
- Study completion26 Jan 2025
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Sleep Research Society Foundation
- Responsible party
- Principal investigator, Nicole Gumport, Stanford University
- Investigators
- Nicole Gumport, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814783
- Sponsor's protocol ID
- 68391
- Status last verified
- Jun 2025
- First submitted
- 1 Mar 2023
- Last updated
- 11 Jun 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinician Training Program to Integrate Digital Cognitive Behavior Therapy for Insomnia Into Routine Psychotherapy
- ClinicalTrials.gov ID
- NCT05814783
- Acronym / sponsor ID
- 68391
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Sleep Research Society Foundation
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 26 Jan 2025 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 18 Apr 2023 (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 goal of this study is to pilot test and refine a training program for licensed therapists to promote the integration of digital cognitive behavior therapy for insomnia (dCBTi) into their routine mental health care services.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated digital CBTI | Experimental | Behavioral: supported digital CBTI, Device: digital CBTITherapists will be trained to integrate digital CBTI alongside routine psychotherapy. Patients will receive integrated digital CBTI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Licensed mental health clinicians
- Have a clinical care model that includes seeing patients weekly or biweekly
- Provide therapy in English
- Treat patients with depression and/or anxiety
- Can identify 1-2 patients who are willing to consent to be training cases.
Key exclusion criteria (5 listed)
- Not meeting all of the inclusion criteria
- Conditions known to make study treatment less effective (e.g., current chronic medication use known to interfere with sleep, alcohol or substance use disorder, thought disorder)
- Conditions for which dCBTi is a safety risk (e.g., bipolar disorder, excessive daytime sleepiness)
- Current psychotherapy for insomnia
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 |
|---|---|---|
| supported digital CBTIin session support for adherence to and engagement with digital CBTI | Behavioural | Integrated digital CBTI |
| digital CBTICBTI app | Device | Integrated digital CBTI |
Primary outcome
Change in Insomnia Severity Index (ISI)
Time frame: Pre-treatment and immediately post-treatment (treatment phase is 12 weeks)
Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity, patient outcome.
Change in Knowledge of Supporting Integrated dCBTi
Time frame: Pre-training (at the start of the one day training) and immediately post-training (at the end of the one day training)
Therapist outcome assessing knowledge gained during training program measured via a study-specific questionnaire on which higher scores indicating more knowledge
1 secondary outcome
Time spent supporting dCBTi
Time frame: Through study duration, usually 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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.
Nicole Gumport, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supported digital CBTI and digital CBTI in people with Insomnia, run by Stanford University 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jun 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Insomnia Severity Index (ISI) (time frame: Pre-treatment and immediately post-treatment (treatment phase is 12 weeks)). The study lists 2 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 11 Jun 2025.