The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy

Study Overview
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Brief Summary
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This project aims to compare the effectiveness and implementation potential of two primary care friendly approaches to delivering an effective non-pharmacological intervention - cognitive behavioral therapy - for insomnia to middle aged and older adults.

Detailed Description
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All participants will receive cognitive behavioral therapy for insomnia, either through an online program or through visit with a therapist specializing in behavioral sleep medicine, and is some cases both. Participants will be randomized with equal probability to an ONLINE ONLY treatment arm or to a STEPPED CARE arm, whereby they will be assigned to on line or therapist-led treatment, based on their clinical presentation; but those assigned to this arm who start treatment with an online program and do not have sufficient response after 2 months will be switched over to a therapist-led treatment.

Official Title
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Randomized Controlled Study of the Effectiveness of Stepped-Care Sleep Therapy In General Practice

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: ONLINE ONLY
* Behavioral: STEPPED CARE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: insomnia disorder Exclusion Criteria: Unable to be consented in English without an interpreter In poor physical or mental that limits capacity to participate in study treatment (e.g., Mini-Mental State Examination score < 25) Unable to use the internet Study physician determines participation is not medically advised for any reason

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ONLINE ONLY<br>Online cognitive behavioral therapy for insomnia | Behavioral: ONLINE ONLY<br>* Access to an online cognitive behavioral therapy for insomnia<br>|
| Experimental: STEPPED CARE<br>Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both | Behavioral: STEPPED CARE<br>* A two step treatment that starts with either an online or therapist led cognitive behavioral therapy for insomnia, depending on a decision algorithm. Those with insufficient progress to the online treatment after 8 weeks are switched to a therapist-led treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Insomnia Severity Index (ISI) | Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity | at baseline and at months 2, 4, 6, 9, & 12 | 
| Change in the use of prescription sleep medication | the number of minimal effective doses of a given sleep medication over 7 nights; A greater number means that a person is taking more sleep medication, with a value of 0 meaning that the person is not taking any sleep medication. | at baseline and at months 2, 4, 6, 9, & 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) - sleep related impairment questionnaire | Questionnaire measuring sleep related impairment. The range of scores is 8 to 40, with higher score representing greater perceived impairment in function related to sleep. | at baseline and at months 2, 4, 6, 9, & 12 | 
| Change in the PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | A validated questionnaire measuring depressive and anxiety symptom severity. The total score ranges between 0 and 12. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). | at baseline and at months 2, 4, 6, 9, & 12 |