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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293745
• Other study ID #: HUM00130209
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: October 4, 2019

Study information

• Verified date: January 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 4, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Face to Face CBT-I (F2F)
CBT-I delivered in-person by the therapist.
• Telemedicine CBT-I (TM)
CBT-I delivered via American Academy of Sleep Medicine Telemedicine video conference System by the therapist.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	American Academy of Sleep Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Patient Health Questionnaire - 9 (PHQ-9).	The PHQ-9 is a 9-item scale measuring the severity of depressive symptoms (range = 0 - 27, with higher scores reflecting more severe depression).	Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Other	Change in Generalized Anxiety Disorder Questionnaire - 7 (GAD-7)	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).	Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Other	Change in Short-Form Health Survey (SF-12)	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.	Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Other	Change in Multidimensional Fatigue Inventory (MFI-20)	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.	Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Other	Change in Dysfunctional Beliefs About Sleep Scale (DBAS).	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.	Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Other	Change in Work and Social Adjustment Scale (WSAS).	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.	Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Other	Change in Cornell Service Utilization Index (CSUI).	The CSUI is a 10-item measure that assesses participants' use of medical and mental health services over a six month period.	Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Other	Change in Working Alliance Inventory - Short Revised (WAI-SR).	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.	Weekly for about 6 weeks
Other	Change in sleep diary measures	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)	Baseline, daily during the 6-week treatment, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Other	Change in actigraphy measures	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)	Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Primary	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	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)
Secondary	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)