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Completed

NCT Number: NCT07180784

Psychological Interventions for Students With Insomnia

This study looked at university students who had trouble sleeping and compared two different programs designed to help with insomnia. One program was mindfulness-based stress reduction (MBSR), which focuses on meditation and awareness techniques, and the other was cognitive-behavioral therapy for insomnia (CBT-I), a structured approach that teaches strategies to change thoughts and habits around sleep. Participants were randomly assigned to one of the two programs. The researchers wanted to see how each program affected insomnia symptoms and related factors like stress, anxiety, mood, and overall quality of life. The researchers expected that CBT-I would lead to faster improvements right after the program, but they also believed that the mindfulness program would work just as well in the longer term, notably, three months after treatment.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'étude des troubles du sommeil (CETS) de l'université Laval

Québec, Quebec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female students aged 18 to 35 years from Université Laval;
  • Meet the Diagnostic and Statistical Manual of Mental Disorders 5th Version (DSM-5) criteria for insomnia disorder;
  • Report at least one consequence of insomnia on daytime functioning;
  • Are available and committed to attending group therapy sessions of approximately 1.5 hours each, held over 8 consecutive weeks.

Exclusion criteria

  • Presence of another major psychiatric disorder or other sleep disorder that could explain the insomnia symptoms;
  • Presence of a serious medical condition (e.g., chronic pain);
  • Previous participation in cognitive-behavioral therapy for insomnia (CBT-I) or prior completion of a mindfulness-based program (e.g., mindfulness-based stress reduction [MBSR], mindfulness-based cognitive therapy [MBCT]);
  • Refusal to discontinue the use of substances (e.g., over-the-counter sleep aids, marijuana, alcohol) for the sole purpose of sleep aids for the duration of the study;
  • Having a highly irregular sleep schedule (e.g., going to bed almost every night after 1:00 a.m. and waking up after 10:00 a.m.).

Treatment and study plan

Mindfulness-Based Stress Reduction (MBSR)

Behavioral

An intervention group offered to students that teaches meditation and yoga techniques, stress physiology, and mindfulness practices. Each group includes 5-6 participants and met once a week for 1.5 hours over a period of 8 consecutive weeks.

Cognitive Behaviour Therapy for Insomnia (CBT-I)

Behavioral

Traditional CBT-I was offered in small group sessions of 5 to 6 participants and lasted 1.5 hours each. They were held once a week over a period of 8 consecutive weeks.

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program

    The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire used to evaluate the severity of insomnia symptoms (e.g., difficulties falling asleep). Total scores range from 0 to 28, with higher scores indicating greater insomnia severity (worse outcome). Score interpretation: 0-7 = no clinically significant insomnia; 8-14 = subthreshold insomnia; 15-21 = clinical insomnia (moderate severity); 22-28 = clinical insomnia (severe).

Secondary outcomes

  1. The Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program

    The Patient Health Questionnaire-9 (PHQ-9) is a nine-item self-report questionnaire used to assess the severity of depressive symptoms. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms (i.e., a worse outcome).

  2. The Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program

    The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire used to assess the severity of generalized anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity (worse outcome). Score interpretation: 0-4 = minimal anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; 15-21 = severe anxiety.

  3. The Perceived Stress Scale (PSS-14)

    Time frame: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program

    The Perceived Stress Scale (PSS-14) is a 14-item self-report questionnaire that measures the degree to which individuals perceive their life situations as stressful over the past month. Total scores range from 0 to 56, with higher scores indicating greater perceived stress (worse outcome). Score interpretation: 0-13 = low stress; 14-26 = moderate stress; 27-40 = high stress.

  4. The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

    Time frame: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program

    The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16-item self-report questionnaire that assesses overall satisfaction and enjoyment across various areas of daily functioning and quality of life. Total raw scores range from 14 to 70, which are typically converted into a percentage of the maximum possible score. Higher scores indicate greater enjoyment and satisfaction with quality of life (better outcome).

Other outcomes

  1. Actigraphy

    Time frame: Baseline: 10 days recording prior to the start of the 8-week program; Post-treatment: 10 days recording starting within one day after completion of the 8-week program

    The actigraph (Actiwatch 2, Philips Respironics, Bend, OR) is a wrist-worn device that measures movement to estimate sleep-wake patterns and activity levels over time. Data are typically reported as total sleep time, sleep onset latency, wake after sleep onset, and sleep efficiency. Higher sleep efficiency and longer total sleep time indicate better sleep outcomes, whereas longer sleep onset latency and greater wake after sleep onset indicate worse sleep outcomes.

  2. Sleep diary

    Time frame: Baseline: 10 days recording prior to the start of the 8-week program; Post-treatment: 10 days recording within one day after completion of the 8-week program; Follow-up: 10 days recording three months after completion of the 8-week program

    The Sleep Diary is a daily self-report log used to record sleep patterns, bedtime habits, and related factors to better understand and manage sleep difficulties. Variables derived from the diary include total sleep time, sleep onset latency, wake after sleep onset, and sleep efficiency. Higher sleep efficiency and longer total sleep time indicate better sleep outcomes, whereas longer sleep onset latency and greater wake after sleep onset indicate worse sleep outcomes.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Mindfulness-Based Stress Reduction Compared With Cognitive Behavioral Therapy to Improve Sleep and Mental Health in University Students With Insomnia

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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