Skip to main content
OpenTrials
Completed

NCT Number: NCT03293745

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current diagnosis of insomnia

Exclusion criteria

  • 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

Treatment and study plan

Face to Face CBT-I (F2F)

Behavioral

CBT-I delivered in-person by the therapist.

Telemedicine CBT-I (TM)

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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)

  10. 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)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Academy of Sleep Medicine

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2017
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.