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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2019-10-04

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.

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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.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Face to Face CBT-I (F2F)

Intervention Type BEHAVIORAL

CBT-I delivered in-person by the therapist.

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.

Group Type EXPERIMENTAL

Telemedicine CBT-I (TM)

Intervention Type BEHAVIORAL

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

Interventions

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Face to Face CBT-I (F2F)

CBT-I delivered in-person by the therapist.

Intervention Type BEHAVIORAL

Telemedicine CBT-I (TM)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No