Optimization of Insomnia Treatment in Primary Care

Study Overview
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Brief Summary
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The primary objective of this pragmatic clinical trial is to evaluate the efficacy, feasibility, and adaptability of pharmacological and non-pharmacological treatments for insomnia disorder, delivered in primary care clinics. The second objective is to evaluate the efficacy of a sequential (stepped care) approach for persistent insomnia.

Official Title
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Stepped Care Treatment for Insomnia Delivered in Primary Care Clinics: A Pragmatic Clinical Trial

Conditions
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Insomnia Disorder

Intervention / Treatment
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* Drug: Hypnotics
* Behavioral: Online CBT
* Behavioral: Face-to-face CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or over Meeting criteria for insomnia disorder Registered patient at one of the primary care clinics participating in the study Fluent in French Computer and internet access Exclusion Criteria: Unstable or untreated psychiatric disorder Lifetime psychotic or bipolar disorder Current suicide risk Progressive or unstable medical disorder Untreated sleep disorder other than insomnia Use of medication altering sleep Irregular or atypical sleep-wake schedule Current or planned pregnancy

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The study involves two treatment phases of six to eight weeks. In the first phase, participants choose medication (treatment as usual), online cognitive behavior therapy, or online cognitive behavior therapy combined with medication. Participants enter a second treatment phase if they still experience insomnia after the first treatment. The treatment arms for the second phase are medication, in-person cognitive-behavior therapy, or no additional treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual<br>Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks | Drug: Hypnotics<br>* Medication used 1 to 7 nights/week for 6 to 8 weeks.<br>|
| Experimental: Online cognitive behavior therapy<br>Online CBT- Internet self-help program for insomnia with 6 cores | Behavioral: Online CBT<br>* Internet self-help program for insomnia with 6 cores.<br>|
| Experimental: Treatment as usual + Online CBT<br>Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks Online CBT- Internet self-help program for insomnia with 6 cores | Drug: Hypnotics<br>* Medication used 1 to 7 nights/week for 6 to 8 weeks.<br>Behavioral: Online CBT<br>* Internet self-help program for insomnia with 6 cores.<br>|
| Experimental: Medication<br>Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4) | Drug: Hypnotics<br>* Medication used 1 to 7 nights/week for 6 to 8 weeks.<br>|
| Experimental: In-person cognitive behavior therapy<br>Face-to-face CBT- Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks. | Behavioral: Face-to-face CBT<br>* Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.<br>|
| No Intervention: No additional treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission of insomnia | Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10) | Post-1 (after 6-week treatment phase 1) | 
| Remission of insomnia | Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10) | Post-2 (after 6-week treatment phase 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sleep time from sleep diary | Mean total sleep time per night in minutes from sleep diary | Post-1 (after 6-week treatment phase 1) | 
| Total sleep time from sleep diary | Mean total sleep time per night in minutes from sleep diary | Post-2 (after 6-week treatment phase 2) | 
| Total wake time from sleep diary | Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary | Post-1 (after 6-week treatment phase 1) | 
| Total wake time from sleep diary | Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary | Post-2 (after 6-week treatment phase 2) | 
| Sleep efficiency from sleep diary | Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary | Post-1 (after 6-week treatment phase 1) | 
| Sleep efficiency from sleep diary | Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary | Post-2 (after 6-week treatment phase 2) | 
| Total sleep time from actigraphy | Mean total sleep time per night in minutes from actigraphy | Post-1 (after 6-week treatment phase 1) | 
| Total sleep time from actigraphy | Mean total sleep time per night in minutes from actigraphy | Post-2 (after 6-week treatment phase 2) | 
| Total wake time from actigraphy | Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy | Post-1 (after 6-week treatment phase 1) | 
| Total wake time from actigraphy | Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy | Post-2 (after 6-week treatment phase 2) | 
| Sleep efficiency from actigraphy | Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy | Post-1 (after 6-week treatment phase 1) | 
| Sleep efficiency from actigraphy | Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy | Post-2 (after 6-week treatment phase 2) | 
| Fatigue | Flinders Fatigue Scale (7-item self-report scale measuring fatigue over the past two weeks; total score ranges from 0 to 31, higher scores indicating greater fatigue) | Post-1 (after 6-week treatment phase 1) | 
| Fatigue | Flinders Fatigue Scale (7-item self-report scale measuring fatigue over the past two weeks; total score ranges from 0 to 31, higher scores indicating greater fatigue) | Post-2 (after 6-week treatment phase 2) | 
| Depression | Patient Health Questionnaire (PHQ-9) | Post-1 (after 6-week treatment phase 1) | 
| Depression | Patient Health Questionnaire (PHQ-9) | Post-2 (after 6-week treatment phase 2) | 
| Anxiety | Generalized Anxiety Disorder 7-item (GAD-7) | Post-1 (after 6-week treatment phase 1) | 
| Anxiety | Generalized Anxiety Disorder 7-item (GAD-7) | Post-2 (after 6-week treatment phase 2) | 
| Disability | Work and Social Adjustment Scale (5-item scale scale assessing functional impact of insomnia; total score ranging from 0 to 40, higher scores indicating greater disability) | Post-1 (after 6-week treatment phase 1) | 
| Disability | Work and Social Adjustment Scale (5-item scale scale assessing functional impact of insomnia; total score ranging from 0 to 40, higher scores indicating greater disability) | Post-2 (after 6-week treatment phase 2) | 
| Medication use | Frequency of use (number of nights/week) | Post-1 (after 6-week treatment phase 1) | 
| Medication use | Frequency of use (number of nights/week) | Post-2 (after 6-week treatment phase 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Pragmatic Clinical Trial, Drug Therapy, Cognitive Behavior Therapy, Primary Care