InsomniaNCT03313466
Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia
A study testing Internet cognitive behavioral therapy for insomnia (iCBTI) and Class in sleeping well and improving insomnia in people with Insomnia, run by Kaiser Permanente at 1 site in United States.
Trial summary
The investigators will conduct a randomized, controlled trial of internet-based cognitive behavioral therapy (iCBT) vs usual care for insomnia. The target population is patients prescribed medications for insomnia who have not had a dispensation of these medications in the preceding six months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Internet cognitive behavioral therapy for insomnia (iCBTI) and Class in sleeping well and improving insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136,630 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2018to 19 Jun 2019
- 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
- A prescription for any of a set of selected insomnia medications.
- Age >18 years at the time of the prescription.
- A recent (<30 days before the prescription date) diagnosis of insomnia as determined by a set of selected International Classification of Disease (ICD) codes, to be used for medications that are not prescribed just for insomnia.
- Membership for >365 days prior to the prescription date.
- No evidence of a dispensed insomnia medication within six months (183 days) of the current prescription.
Who cannot join
- Contained in inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Southern California
Pasadena, California, 91101
About this study
Official title: Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications
The investigators will conduct a randomized, controlled trial of internet-based cognitive behavioral therapy (iCBT) vs usual care for insomnia. The target population is patients prescribed medications for insomnia who have not had a dispensation of these medications in the preceding six months. The primary outcomes is dispensed days supply over the subsequent one year. Secondary outcomes include all types of health system clinical encounters. The investigators hypothesize that the group randomized into iCBT will have less insomnia medications dispensed than usual care controls, and less clinical encounters..
- Conditions
- Insomnia
- Being tested
- Internet cognitive behavioral therapy for insomnia (iCBTI), Class in sleeping well and improving insomnia
- 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.
Internet cognitive behavioral therapy for insomnia (iCBTI)Behavioural
An internet-based program for providing individually tailored CBTI based on participant responses to questions and performance on weekly guided sleep strategies.
Class in sleeping well and improving insomniaBehavioural
A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.
| Study group | Role | What they receive |
|---|---|---|
| iCBTI | Experimental | Intervention: An internet-based cognitive behavioral therapy program for insomnia (iCBTI) that is tailored to the individual's needs based on responses to questions. Receives: Behavioral: Internet cognitive behavioral therapy for insomnia (iCBTI) |
| Usual care | Active comparator | Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center. Receives: Behavioral: Class in sleeping well and improving insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days supply of dispensed insomnia medications
Days supply of dispensed insomnia medications up to one year after randomization.
Measured: One year
Secondary outcomes (1)
Health care inpatient and outpatient encounters
Number of physician or mid-level provider encounters (face-to-face, telephone, video): (1) outpatient, (2) acute care: emergency, inpatient, up to one year after randomization.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start13 Mar 2018
- Primary completion19 Jun 2018
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136,630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Big Health Inc.
- Responsible party
- Sponsor
- Investigators
- Stephen Derose, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313466
- Sponsor's protocol ID
- 11262
- Status last verified
- May 2020
- First submitted
- 9 Oct 2017
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Derose SF, Rozema E, Chen A, Shen E, Hwang D, Manthena P. A population health approach to insomnia using internet-based cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2021 Aug 1;17(8):1675-1684. doi: 10.5664/jcsm.9280.
PubMed 33908343
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications
- ClinicalTrials.gov ID
- NCT03313466
- Acronym / sponsor ID
- 11262
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136,630 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Big Health Inc.
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 18 Oct 2017 (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 investigators will conduct a randomized, controlled trial of internet-based cognitive behavioral therapy (iCBT) vs usual care for insomnia. The target population is patients prescribed medications for insomnia who have not had a dispensation of these medications in the preceding six months. The primary outcomes is dispensed days supply over the subsequent one year. Secondary outcomes include all types of health system clinical encounters. The investigators hypothesize that the group randomized into iCBT will have less insomnia medications dispensed than usual care controls, and less clinical encounters..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCBTI | Experimental | Behavioral: Internet cognitive behavioral therapy for insomnia (iCBTI)Intervention: An internet-based cognitive behavioral therapy program for insomnia (iCBTI) that is tailored to the individual's needs based on responses to questions. |
| Usual care | Active comparator | Behavioral: Class in sleeping well and improving insomniaIntervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A prescription for any of a set of selected insomnia medications.
- Age >18 years at the time of the prescription.
- A recent (<30 days before the prescription date) diagnosis of insomnia as determined by a set of selected International Classification of Disease (ICD) codes, to be used for medications that are not prescribed just for insomnia.
- Membership for >365 days prior to the prescription date.
- No evidence of a dispensed insomnia medication within six months (183 days) of the current prescription.
Key exclusion criteria (1 listed)
- Contained in inclusion criteria.
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 |
|---|---|---|
| Internet cognitive behavioral therapy for insomnia (iCBTI)An internet-based program for providing individually tailored CBTI based on participant responses to questions and performance on weekly guided sleep strategies. | Behavioural | iCBTI |
| Class in sleeping well and improving insomniaA group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia. | Behavioural | Usual care |
Primary outcome
Days supply of dispensed insomnia medications
Time frame: One year
Days supply of dispensed insomnia medications up to one year after randomization.
1 secondary outcome
Health care inpatient and outpatient encounters
Time frame: One year
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 28 May 2020.
- Derived from this study: PubMed 33908343Derose SF, Rozema E, Chen A, Shen E, Hwang D, Manthena P. A population health approach to insomnia using internet-based cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2021 Aug 1;17(8):1675-1684. doi: 10.5664/jcsm.9280.
- 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.
Stephen Derose, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet cognitive behavioral therapy for insomnia (iCBTI) and Class in sleeping well and improving insomnia in people with Insomnia, run by Kaiser Permanente 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 1 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 28 May 2020. 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?
Days supply of dispensed insomnia medications (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03313466, which also lists 1 linked publication.
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 28 May 2020.