NCT03293745

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2019

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

September 19, 2017

Last Update Submit

January 25, 2023

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • 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)

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

Secondary Outcomes (2)

  • Client Satisfaction Questionnaire (CSQ-8)

    Post-treatment (about 6 weeks)

  • Change in Therapy Evaluation Questionnaire (TEQ)

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

Other Outcomes (10)

  • Change in Patient Health Questionnaire - 9 (PHQ-9).

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

  • Change in Generalized Anxiety Disorder Questionnaire - 7 (GAD-7)

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

  • Change in Short-Form Health Survey (SF-12)

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

  • +7 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Telemedicine CBT-I (TM)

Interventions

Face to Face CBT-I (F2F)BEHAVIORAL

CBT-I delivered in-person by the therapist.

Face to Face CBT-I (F2F)
Telemedicine CBT-I (TM)BEHAVIORAL

CBT-I delivered via American Academy of Sleep Medicine Telemedicine video conference System by the therapist.

Telemedicine CBT-I (TM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Current diagnosis of insomnia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

    PMID: 32658298DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Todd Arnedt, PhD

    University of Michigan Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 26, 2017

Study Start

November 15, 2017

Primary Completion

October 4, 2019

Study Completion

October 4, 2019

Last Updated

January 27, 2023

Record last verified: 2023-01

Locations

US(1)