Cognitive Behavioral Therapy for Insomnia: Face-to-Face Versus Telemedicine

January 25, 2023 updated by: J. Todd Arnedt, University of Michigan
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Current diagnosis of insomnia

Exclusion Criteria:

  1. Suspicion of or inadequately treated sleep disorder other than insomnia
  2. Presence of psychiatric disorders for which CBT for insomnia may be contraindicated
  3. Unstable chronic medical condition directly related to insomnia
  4. Routine overnight shift work
  5. Previous failed adequate trial of CBT for insomnia
  6. Unstable dose of sleep medications
  7. Lack of access to reliable WiFi connection in the home

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Behavioral: Face to Face CBT-I (F2F)
CBT-I delivered in-person by the therapist.
Experimental: 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.
Behavioral: Telemedicine CBT-I (TM)
CBT-I delivered via American Academy of Sleep Medicine Telemedicine video conference System by the therapist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Post-treatment (about 6 weeks)

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.
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)
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.
Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire - 9 (PHQ-9).
Time Frame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
The PHQ-9 is a 9-item scale measuring the severity of depressive symptoms (range = 0 - 27, with higher scores reflecting more severe depression).
Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Change in Generalized Anxiety Disorder Questionnaire - 7 (GAD-7)
Time Frame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
The GAD-7 is a 7-item survey that measures the severity of anxiety symptoms (range = 0-21, with higher scores reflecting higher levels of anxiety).
Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Change in Short-Form Health Survey (SF-12)
Time Frame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
The 12-item Short-Form Health Survey (SF-12) is a short-form quality of life measure derived from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), which computes physical and mental composite scale scores ranging from 0 to 100.
Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Change in Multidimensional Fatigue Inventory (MFI-20)
Time Frame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
The MFI-20 is a 20-item scale with five subscales representing dimensions of general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Higher scores indicate greater fatigue.
Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Change in Dysfunctional Beliefs About Sleep Scale (DBAS).
Time Frame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
The DBAS is a 16-item measure (range: 0-160, with greater scores reflection greater degrees of negative thinking and beliefs related to sleep which presents a series of negative statements or beliefs about sleep. Patients rate the degree to which they agree with or believe each statement.
Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Change in Work and Social Adjustment Scale (WSAS).
Time Frame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
The WSAS is a 5-item questionnaire assessing perceived degree of impairment in work and social domains. Scores range from 0 to 40, with higher scores reflecting greater levels of impairment.
Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Change in Cornell Service Utilization Index (CSUI).
Time Frame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
The CSUI is a 10-item measure that assesses participants' use of medical and mental health services over a six month period.
Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Change in Working Alliance Inventory - Short Revised (WAI-SR).
Time Frame: Weekly for about 6 weeks
The WAI-SR is a 12-item measure that assesses the degree to which patients perceive a positive working relationship with their therapist. Scores range from 12-60, with higher scores reflecting greater levels of perceived working alliance with the therapist.
Weekly for about 6 weeks
Change in sleep diary measures
Time Frame: Baseline, daily during the 6-week treatment, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Participants will keep sleep diaries daily for 2 weeks at baseline, during treatment, for 2 weeks post-treatment, and for 2 weeks at 12-week post-treatment follow-up. Primary outcomes will include mean sleep efficiency (SE = total sleep time/time in bed*100)
Baseline, daily during the 6-week treatment, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Change in actigraphy measures
Time Frame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Participants will wear an actigraph for 2 weeks at baseline, for 2 weeks post-treatment and for 2 weeks at 12-week post-treatment follow-up. Outcomes will include mean sleep efficiency (SE = total sleep time/time in bed*100)
Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Academy of Sleep Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Todd Arnedt, PhD, University of Michigan Department of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00130209

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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