Clinical trial NCT03293745: Cognitive Behavioral Therapy for Insomnia: Face-to-Face Versus Telemedicine
Official title: Cognitive Behavioral Therapy for Insomnia: Face-to-Face Versus Telemedicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2017-09-26
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Secondary outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-treatment (about 6 weeks)
measure: Change in Therapy Evaluation Questionnaire (TEQ)
timeFrame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Other outcomes:
measure: Change in Patient Health Questionnaire - 9 (PHQ-9).
timeFrame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
measure: Change in Generalized Anxiety Disorder Questionnaire - 7 (GAD-7)
timeFrame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
measure: Change in Short-Form Health Survey (SF-12)
timeFrame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
measure: Change in Multidimensional Fatigue Inventory (MFI-20)
timeFrame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
measure: Change in Dysfunctional Beliefs About Sleep Scale (DBAS).
timeFrame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
measure: Change in Work and Social Adjustment Scale (WSAS).
timeFrame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
measure: Change in Cornell Service Utilization Index (CSUI).
timeFrame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
measure: Change in Working Alliance Inventory - Short Revised (WAI-SR).
timeFrame: Weekly for about 6 weeks
measure: Change in sleep diary measures
timeFrame: Baseline, daily during the 6-week treatment, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
measure: Change in actigraphy measures
timeFrame: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Department of Psychiatry
name: Todd Arnedt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnedt JT, Conroy DA, Mooney A, Furgal A, Sen A, Eisenberg D. Telemedicine versus face-to-face delivery of cognitive behavioral therapy for insomnia: a randomized controlled noninferiority trial. Sleep. 2021 Jan 21;44(1):zsaa136. doi: 10.1093/sleep/zsaa136.