Insomnia DisorderNCT03328585
Telemedicine vs. In-person Delivery of Cognitive Behavioral Treatment of Insomnia: a Mixed Methods Analysis
A study testing CBT-I in person and CBT-I via Telemedicine in people with Insomnia Disorder, run by University of Pennsylvania at 1 site in United States.
Trial summary
Cognitive behavioral therapy for insomnia (CBT-I) has been the 'gold standard' for the treatment of insomnia. There is a need to increase access to treatment, particularly for patients in more rural locations where providers may be scarce. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- CBT-I in person and CBT-I via Telemedicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2017to 1 Oct 2020
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet current DSM5 criteria for Insomnia Disorder as determined by clinician interview
- ISI score greater than 14, with self-reported duration of insomnia of at least 3 months
- Ability to read and speak English
- Own a personal computer with an internet connection sufficient to utilize the SleepTM and REDCap platform
- BMI less than 30
- Between the ages of 21-50
Who cannot join
- Unable or unwilling to provide informed consent
- Individuals with an untreated sleep disorder other than insomnia (Individuals with sleep apnea who are adherent with CPAP treatment (average 4 hours use per night) will be eligible to participate)
- A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months
- Individuals with substance abuse/dependence, bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia, and other psychotic disorders
- Individuals with prominent current suicidal or homicidal ideation
- Unable to perform tests due to inability to communicate verbally, inability to read and write; less than a 5th grade reading level; visual, hearing, or cognitive impairment
- Any use of medications or OTC products that might impact sleep or metabolism
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Cognitive behavioral therapy for insomnia (CBT-I) has been the 'gold standard' for the treatment of insomnia. There is a need to increase access to treatment, particularly for patients in more rural locations where providers may be scarce. One solution is to utilize telemedicine which is "the use of electronic communications to provide and support health care when distance separates the provider from the patient." So the purpose of the study is to determine if receiving CBT-I by video teleconferencing works just as well as in-person treatment.
- Conditions
- Insomnia Disorder
- Being tested
- CBT-I in person, CBT-I via Telemedicine, No intervention
- Keywords
- CBT-I, Telemedicine
- 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.
CBT-I in personBehavioural
6 weeks of CBT-I in person, one 1-hour long session per week
CBT-I via TelemedicineBehavioural
6 weeks of CBT-I via telemedicine, one 1-hour long session per week
No interventionOther
Patients in this arm will receive no intervention but will receive CBT-I treatment after conclusion of the study
| Study group | Role | What they receive |
|---|---|---|
| CBT-I in person | Active comparator | Not described Receives: Behavioral: CBT-I in person |
| CBT-I via telemedicine | Experimental | Not described Receives: Behavioral: CBT-I via Telemedicine |
| Waitlist Control | Other | Patients in this arm will receive in person CBT-I treatment after conclusion of the study. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ISI scores
Total score on the Insomnia Severity Index (0-28)
Measured: Once at baseline assessment and once again at follow-up after CBT-I intervention approximately 9 weeks later
Secondary outcomes (1)
Change in actigraphic sleep efficiency
Measured using an actigraph wristband
Measured: Patients will wear the wristband for a week during sleep baseline assessment and again for a week at follow-up, approximately 8 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start21 Nov 2017
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
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 Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328585
- Sponsor's protocol ID
- 827001
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2017
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gehrman P, Gunter P, Findley J, Frasso R, Weljie AM, Kuna ST, Kayser MS. Randomized Noninferiority Trial of Telehealth Delivery of Cognitive Behavioral Treatment of Insomnia Compared to In-Person Care. J Clin Psychiatry. 2021 Aug 24;82(5):20m13723. doi: 10.4088/JCP.20m13723.
PubMed 34428360
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine vs. In-person Delivery of Cognitive Behavioral Treatment of Insomnia: a Mixed Methods Analysis
- ClinicalTrials.gov ID
- NCT03328585
- Acronym / sponsor ID
- 827001
- Conditions
- Insomnia Disorder
- Keywords
- CBT-I, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 1 Nov 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.
Cognitive behavioral therapy for insomnia (CBT-I) has been the 'gold standard' for the treatment of insomnia. There is a need to increase access to treatment, particularly for patients in more rural locations where providers may be scarce. One solution is to utilize telemedicine which is "the use of electronic communications to provide and support health care when distance separates the provider from the patient." So the purpose of the study is to determine if receiving CBT-I by video teleconferencing works just as well as in-person treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-I in person | Active comparator | Behavioral: CBT-I in person |
| CBT-I via telemedicine | Experimental | Behavioral: CBT-I via Telemedicine |
| Waitlist Control | Other | Other: No interventionPatients in this arm will receive in person CBT-I treatment after conclusion of the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet current DSM5 criteria for Insomnia Disorder as determined by clinician interview
- ISI score greater than 14, with self-reported duration of insomnia of at least 3 months
- Ability to read and speak English
- Own a personal computer with an internet connection sufficient to utilize the SleepTM and REDCap platform
- BMI less than 30
Key exclusion criteria (7 listed)
- Unable or unwilling to provide informed consent
- Individuals with an untreated sleep disorder other than insomnia (Individuals with sleep apnea who are adherent with CPAP treatment (average 4 hours use per night) will be eligible to participate)
- A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months
- Individuals with substance abuse/dependence, bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia, and other psychotic disorders
- Individuals with prominent current suicidal or homicidal ideation
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 |
|---|---|---|
| CBT-I in person6 weeks of CBT-I in person, one 1-hour long session per week | Behavioural | CBT-I in person |
| CBT-I via Telemedicine6 weeks of CBT-I via telemedicine, one 1-hour long session per week | Behavioural | CBT-I via telemedicine |
| No interventionPatients in this arm will receive no intervention but will receive CBT-I treatment after conclusion of the study | Other | Waitlist Control |
Primary outcome
Change in ISI scores
Time frame: Once at baseline assessment and once again at follow-up after CBT-I intervention approximately 9 weeks later
Total score on the Insomnia Severity Index (0-28)
1 secondary outcome
Change in actigraphic sleep efficiency
Time frame: Patients will wear the wristband for a week during sleep baseline assessment and again for a week at follow-up, approximately 8 weeks later
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 8 Oct 2020.
- Derived from this study: PubMed 34428360Gehrman P, Gunter P, Findley J, Frasso R, Weljie AM, Kuna ST, Kayser MS. Randomized Noninferiority Trial of Telehealth Delivery of Cognitive Behavioral Treatment of Insomnia Compared to In-Person Care. J Clin Psychiatry. 2021 Aug 24;82(5):20m13723. doi: 10.4088/JCP.20m13723.
- 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 CBT-I in person and CBT-I via Telemedicine in people with Insomnia Disorder, run by University of Pennsylvania 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 6 inclusion and 7 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 8 Oct 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?
Change in ISI scores (time frame: Once at baseline assessment and once again at follow-up after CBT-I intervention approximately 9 weeks later). 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 NCT03328585, 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 8 Oct 2020.