Insomnia
Conditions
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.
Interventions
BEHAVIORALFace to Face CBT-I (F2F)
CBT-I delivered in-person by the therapist.
BEHAVIORALTelemedicine CBT-I (TM)
CBT-I delivered via American Academy of Sleep Medicine Telemedicine video conference System by the therapist.
Sponsors
American Academy of Sleep Medicine
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Multidimensional Fatigue Inventory (MFI-20) | Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment) | 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. |
| Change in Dysfunctional Beliefs About Sleep Scale (DBAS). | Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment) | 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. |
| Change in Work and Social Adjustment Scale (WSAS). | Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment) | 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. |
| Change in Patient Health Questionnaire - 9 (PHQ-9). | Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment) | The PHQ-9 is a 9-item scale measuring the severity of depressive symptoms (range = 0 - 27, with higher scores reflecting more severe depression). |
| Change in Working Alliance Inventory - Short Revised (WAI-SR). | Weekly for about 6 weeks | 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. |
| Change in sleep diary measures | Baseline, daily during the 6-week treatment, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment) | 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) |
| Change in actigraphy measures | Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment) | 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) |
| Change in Cornell Service Utilization Index (CSUI). | Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment) | The CSUI is a 10-item measure that assesses participants' use of medical and mental health services over a six month period. |
| Change in Generalized Anxiety Disorder Questionnaire - 7 (GAD-7) | Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment) | 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). |
| Change in Short-Form Health Survey (SF-12) | Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment) | 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. |
Countries
United States
Outcome results
None listed