Optimization of Insomnia Treatment in Primary Care

Sponsor

Laval University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03633305

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Disorder	Drug: Hypnotics Behavioral: Online CBT Behavioral: Face-to-face CBT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Remission of insomnia [Post-1 (after 6-week treatment phase 1)]
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
Remission of insomnia [Post-2 (after 6-week treatment phase 2)]
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)

Secondary Outcome Measures

Total sleep time from sleep diary [Post-1 (after 6-week treatment phase 1)]
Mean total sleep time per night in minutes from sleep diary
Total sleep time from sleep diary [Post-2 (after 6-week treatment phase 2)]
Mean total sleep time per night in minutes from sleep diary
Total wake time from sleep diary [Post-1 (after 6-week treatment phase 1)]
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary
Total wake time from sleep diary [Post-2 (after 6-week treatment phase 2)]
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary
Sleep efficiency from sleep diary [Post-1 (after 6-week treatment phase 1)]
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary
Sleep efficiency from sleep diary [Post-2 (after 6-week treatment phase 2)]
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary
Total sleep time from actigraphy [Post-1 (after 6-week treatment phase 1)]
Mean total sleep time per night in minutes from actigraphy
Total sleep time from actigraphy [Post-2 (after 6-week treatment phase 2)]
Mean total sleep time per night in minutes from actigraphy
Total wake time from actigraphy [Post-1 (after 6-week treatment phase 1)]
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy
Total wake time from actigraphy [Post-2 (after 6-week treatment phase 2)]
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy
Sleep efficiency from actigraphy [Post-1 (after 6-week treatment phase 1)]
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy
Sleep efficiency from actigraphy [Post-2 (after 6-week treatment phase 2)]
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy
Fatigue [Post-1 (after 6-week treatment phase 1)]
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)
Fatigue [Post-2 (after 6-week treatment phase 2)]
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)
Depression [Post-1 (after 6-week treatment phase 1)]
Patient Health Questionnaire (PHQ-9)
Depression [Post-2 (after 6-week treatment phase 2)]
Patient Health Questionnaire (PHQ-9)
Anxiety [Post-1 (after 6-week treatment phase 1)]
Generalized Anxiety Disorder 7-item (GAD-7)
Anxiety [Post-2 (after 6-week treatment phase 2)]
Generalized Anxiety Disorder 7-item (GAD-7)
Disability [Post-1 (after 6-week treatment phase 1)]
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)
Disability [Post-2 (after 6-week treatment phase 2)]
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)
Medication use [Post-1 (after 6-week treatment phase 1)]
Frequency of use (number of nights/week)
Medication use [Post-2 (after 6-week treatment phase 2)]
Frequency of use (number of nights/week)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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