InsomniaNCT03293745
Cognitive Behavioral Therapy for Insomnia: Face-to-Face Versus Telemedicine
A study testing Face to Face CBT-I (F2F) and Telemedicine CBT-I (TM) in people with Insomnia, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of Cognitive-Behavioral Therapy (CBT) for insomnia conducted face-to-face with a therapist versus CBT for insomnia conducted using Internet-based videoconference technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Face to Face CBT-I (F2F) and Telemedicine CBT-I (TM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 4 Oct 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
- 1. Current diagnosis of insomnia
Who cannot join
- Suspicion of or inadequately treated sleep disorder other than insomnia
- Presence of psychiatric disorders for which CBT for insomnia may be contraindicated
- Unstable chronic medical condition directly related to insomnia
- Routine overnight shift work
- Previous failed adequate trial of CBT for insomnia
- Unstable dose of sleep medications
- Lack of access to reliable WiFi connection in the home
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the effectiveness of Cognitive-Behavioral Therapy (CBT) for insomnia conducted face-to-face with a therapist versus CBT for insomnia conducted using Internet-based videoconference technology.
Read the detailed description
The objective of this clinical trial is to compare the effectiveness of telemedicine Cognitive-Behavioral Therapy (CBT) for insomnia [via the American Academy of Sleep Medicine Sleep Telemedicine (AASM Sleep TM) platform] to gold standard face-to-face CBT for insomnia. The central hypothesis is that CBT for insomnia delivered by AASM SleepTM will be comparable to face-to-face CBT for insomnia for clinical outcomes and patient satisfaction, but AASM SleepTM will be a more cost effective treatment modality (primarily through reduced costs associated with facility use and patient time). The rationale for the proposed project is rooted in the critical need to disseminate CBT for insomnia using the most effective and efficient modalities, with recognition that therapist involvement likely produces the most favorable outcomes.
- Conditions
- Insomnia
- Being tested
- Face to Face CBT-I (F2F), Telemedicine CBT-I (TM)
- 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.
Face to Face CBT-I (F2F)Behavioural
CBT-I delivered in-person by the therapist.
Telemedicine CBT-I (TM)Behavioural
CBT-I delivered via American Academy of Sleep Medicine Telemedicine video conference System by the therapist.
| Study group | Role | What they receive |
|---|---|---|
| Face to Face CBT-I (F2F) | Active comparator | Participants in the F2F arm will receive a standard 6-session course of Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered in-person, one-on-one with a qualified and experienced therapist. Receives: Behavioral: Face to Face CBT-I (F2F) |
| Telemedicine CBT-I (TM) | Experimental | Participants in the F2F arm will receive a standard 6-session course of Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via the American Academy of Sleep Medicine (AASM) Sleep Telemedicine system. This telemedicine system provides an online videoconference platform in which a qualified and experienced therapist will deliver CBT-I to participants who will call in to the video therapy sessions with their provider from their homes using a webcam. All aspects of the treatment will remain identical to standard CBT-I delivered face-to-face, as described above, with the exception that the telemedicine technology will be used to deliver the treatment via video conference. Receives: Behavioral: Telemedicine CBT-I (TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI)
The ISI is a 7-item questionnaire assessing the nature, severity, and impact of sleep problems, with good psychometric properties and sensitivity to change with treatment 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Measured: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Secondary outcomes (2)
Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 is an 8-item, easily scored and administered measurement that is designed to measure client satisfaction with services. The items for the CSQ-8 were selected on the basis of ratings by mental health professionals of a number of items that could be related to client satisfaction and by subsequent factor analysis. The CSQ-8 is unidimensional, yielding a homogeneous estimate of general satisfaction with services.
Scores range from 8 - 32, with high scores indicating greater satisfaction.
Measured: Post-treatment (about 6 weeks)
Change in Therapy Evaluation Questionnaire (TEQ)
The TEQ is a 7-item scale with 5 questions to assess perceived logic of and confidence in treatment, willingness to repeat treatment, and the likelihood that the treatment will help others and 2 questions assessing therapist warmth and competence.
Measured: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start15 Nov 2017
- Primary completion4 Oct 2019
- Study completion4 Oct 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 University of MichiganThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Principal investigator, J. Todd Arnedt, University of Michigan
- Investigators
- Todd Arnedt, PhD, Principal investigator, University of Michigan Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293745
- Sponsor's protocol ID
- HUM00130209
- Status last verified
- Jan 2023
- First submitted
- 19 Sep 2017
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arnedt JT, Conroy DA, Mooney A, Furgal A, Sen A, Eisenberg D. Telemedicine versus face-to-face delivery of cognitive behavioral therapy for insomnia: a randomized controlled noninferiority trial. Sleep. 2021 Jan 21;44(1):zsaa136. doi: 10.1093/sleep/zsaa136.
PubMed 32658298
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia: Face-to-Face Versus Telemedicine
- ClinicalTrials.gov ID
- NCT03293745
- Acronym / sponsor ID
- HUM00130209
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 26 Sep 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 purpose of this study is to compare the effectiveness of Cognitive-Behavioral Therapy (CBT) for insomnia conducted face-to-face with a therapist versus CBT for insomnia conducted using Internet-based videoconference technology.
Detailed description
The objective of this clinical trial is to compare the effectiveness of telemedicine Cognitive-Behavioral Therapy (CBT) for insomnia [via the American Academy of Sleep Medicine Sleep Telemedicine (AASM Sleep TM) platform] to gold standard face-to-face CBT for insomnia. The central hypothesis is that CBT for insomnia delivered by AASM SleepTM will be comparable to face-to-face CBT for insomnia for clinical outcomes and patient satisfaction, but AASM SleepTM will be a more cost effective treatment modality (primarily through reduced costs associated with facility use and patient time). The rationale for the proposed project is rooted in the critical need to disseminate CBT for insomnia using the most effective and efficient modalities, with recognition that therapist involvement likely produces the most favorable outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face to Face CBT-I (F2F) | Active comparator | Behavioral: Face to Face CBT-I (F2F)Participants in the F2F arm will receive a standard 6-session course of Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered in-person, one-on-one with a qualified and experienced therapist. |
| Telemedicine CBT-I (TM) | Experimental | Behavioral: Telemedicine CBT-I (TM)Participants in the F2F arm will receive a standard 6-session course of Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via the American Academy of Sleep Medicine (AASM) Sleep Telemedicine system. This telemedicine system provides an online videoconference platform in which a qualified and experienced therapist will deliver CBT-I to participants who will call in to the video therapy sessions with their provider from their homes using a webcam. All aspects of the treatment will remain identical to standard CBT-I delivered face-to-face, as described above, with the exception that the telemedicine technology will be used to deliver the treatment via video conference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Current diagnosis of insomnia
Key exclusion criteria (7 listed)
- Suspicion of or inadequately treated sleep disorder other than insomnia
- Presence of psychiatric disorders for which CBT for insomnia may be contraindicated
- Unstable chronic medical condition directly related to insomnia
- Routine overnight shift work
- Previous failed adequate trial of CBT 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 |
|---|---|---|
| Face to Face CBT-I (F2F)CBT-I delivered in-person by the therapist. | Behavioural | Face to Face CBT-I (F2F) |
| Telemedicine CBT-I (TM)CBT-I delivered via American Academy of Sleep Medicine Telemedicine video conference System by the therapist. | Behavioural | Telemedicine CBT-I (TM) |
Primary outcome
Change in Insomnia Severity Index (ISI)
Time frame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
The ISI is a 7-item questionnaire assessing the nature, severity, and impact of sleep problems, with good psychometric properties and sensitivity to change with treatment 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
2 secondary outcomes
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-treatment (about 6 weeks)
Change in Therapy Evaluation Questionnaire (TEQ)
Time frame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
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 27 Jan 2023.
- Derived from this study: PubMed 32658298Arnedt JT, Conroy DA, Mooney A, Furgal A, Sen A, Eisenberg D. Telemedicine versus face-to-face delivery of cognitive behavioral therapy for insomnia: a randomized controlled noninferiority trial. Sleep. 2021 Jan 21;44(1):zsaa136. doi: 10.1093/sleep/zsaa136.
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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.
Todd Arnedt, PhD principal investigator
University of Michigan Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face to Face CBT-I (F2F) and Telemedicine CBT-I (TM) in people with Insomnia, run by University of Michigan 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 1 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 27 Jan 2023. 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: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)). 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 NCT03293745, 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 27 Jan 2023.