Psychological Interventions for Students With Insomnia

Not Applicable

Completed

• Conditions: Insomnia

• Registration Number: NCT07180784
• Lead Sponsor: Laval University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30
• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	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 Outcome Measures

Name	Time	Method
The Patient Health Questionnaire-9 (PHQ-9)	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).
The Generalized Anxiety Disorder-7 (GAD-7)	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.
The Perceived Stress Scale (PSS-14)	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.
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)	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).

Trial Locations

Locations (1)

Centre d'étude des troubles du sommeil (CETS) de l'université Laval; 🇨🇦 Québec, Quebec, Canada