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
1
6
63
4.8

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
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

  1. Remission of insomnia [Post-1 (after 6-week treatment phase 1)]

    Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)

  2. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Total sleep time from actigraphy [Post-1 (after 6-week treatment phase 1)]

    Mean total sleep time per night in minutes from actigraphy

  8. Total sleep time from actigraphy [Post-2 (after 6-week treatment phase 2)]

    Mean total sleep time per night in minutes from actigraphy

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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)

  14. 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)

  15. Depression [Post-1 (after 6-week treatment phase 1)]

    Patient Health Questionnaire (PHQ-9)

  16. Depression [Post-2 (after 6-week treatment phase 2)]

    Patient Health Questionnaire (PHQ-9)

  17. Anxiety [Post-1 (after 6-week treatment phase 1)]

    Generalized Anxiety Disorder 7-item (GAD-7)

  18. Anxiety [Post-2 (after 6-week treatment phase 2)]

    Generalized Anxiety Disorder 7-item (GAD-7)

  19. 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)

  20. 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)

  21. Medication use [Post-1 (after 6-week treatment phase 1)]

    Frequency of use (number of nights/week)

  22. 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:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laval University Quebec City Quebec Canada G1K 0A6

Sponsors and Collaborators

  • Laval University
  • Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Charles Morin, PhD, Universit√© Laval Centre d'√©tude des troubles du sommeil

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Charles M. Morin, Professor, Laval University
ClinicalTrials.gov Identifier:
NCT03633305
Other Study ID Numbers:
  • CIHR0083000212
First Posted:
Aug 16, 2018
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Charles M. Morin, Professor, Laval University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022