Psychological Interventions for Students With Insomnia

NCT ID: NCT07180784

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-07-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness based stress reduction (MBSR)

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

Group Type: EXPERIMENTAL

Mindfulness-based stress reduction (MBSR)

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

Cognitive Behaviour Therapy for Insomnia (CBT-I)

Intervention Type: 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.

Interventions

Mindfulness-based stress reduction (MBSR)

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.

Intervention Type: BEHAVIORAL

Cognitive Behaviour Therapy for Insomnia (CBT-I)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Amélie Vézina

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

2021-228 A-1 R-1

Identifier Type: -

Identifier Source: org_study_id