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

Not Applicable

Completed

• Conditions: Insomnia

• Registration Number: NCT03293745
• Lead Sponsor: University of Michigan

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.

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 Timeline

• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-26
• Study Start: 2017-11-15
• Primary Completion: 2019-10-04
• Study Completion: 2019-10-04
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity Index (ISI)	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 Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire (CSQ-8)	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.
Change in Therapy Evaluation Questionnaire (TEQ)	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States