Psychological Interventions for Students With Insomnia

NCT07180784 | Completed DMC

• 1 other identifier: 2021-228 A-1 R-1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Insomnia; Mindfulness; Cognitive-behavior therapy; Students

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  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).

  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

Secondary Outcomes (4)

• 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 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 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 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

Other Outcomes (2)

• Actigraphy

  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

• Sleep diary

  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

Study Arms (2)

Mindfulness based stress reduction (MBSR)

EXPERIMENTAL

The participants randomized to this arm received the 8-week MBSR program.

Behavioral: Mindfulness-based stress reduction (MBSR)

Cognitive Behaviour Therapy for Insomnia (CBT-I)

ACTIVE COMPARATOR

The participants randomized to this arm received the 8-week CBT-I treatment.

Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I)

Interventions

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.

Mindfulness based stress reduction (MBSR)

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.

Cognitive Behaviour Therapy for Insomnia (CBT-I)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

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

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Mindfulness-Based Stress Reduction; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled noninferiority trial

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 18, 2025
• Study Start: September 1, 2021
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)