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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Face to Face CBT-I (F2F)
* Behavioral: Telemedicine CBT-I (TM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Face to Face CBT-I (F2F)<br>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)<br>* CBT-I delivered in-person by the therapist.<br>|
| Experimental: Telemedicine CBT-I (TM)<br>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)<br>* CBT-I delivered via American Academy of Sleep Medicine Telemedicine video conference System by the therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment) |