Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress

NCT06038942 | Completed

• 1 other identifier: 23-06-016
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 2

Brief Summary

The present study will use a randomized controlled design to investigate group differences between university students with self-reported stress (comparison group), ADHD, or a history of nonsuicidal self-injury (NSSI) in response to a four-week mindfulness instruction program across conditions (formal mindfulness program, informal mindfulness program, inactive control) in terms of the intervention's acceptability and effectiveness.

Conditions

Nonsuicidal Self-injury; ADHD; Mindfulness

Keywords

nonsuicidal self-injury; ADHD; formal mindfulness; informal mindfulness; university students

Outcome Measures

Primary Outcomes (1)

• Dispositional mindfulness

  The 39-item Five Facets of Mindfulness Questionnaire (FFMQ) will be used to assess dispositional mindfulness. The FFMQ consists of five subscales, each reflecting one facet of mindfulness (acting with awareness, nonjudgmental acceptance, nonreactivity, observing, and describing). Items are rated on a 5-point Likert scale ranging from Never or very rarely true (1) to Very often or always true (5). Global or subscale sum scores may be calculated, whereby higher sum scores reflect greater levels of dispositional mindfulness (either globally or on that specific subscale). Dispositional mindfulness will be assessed across groups and conditions, as well as over time.

  Weeks 1, 6, 10, and 18

Secondary Outcomes (7)

• Emotion regulation style

  Weeks 1, 6, 10, and 18

• Psychological need satisfaction and frustration

  Weeks 1, 6, 10, and 18

• Stress

  Weeks 1, 6, 10, and 18

• Well-being

  Weeks 1, 6, 10, and 18

• Academic engagement

  Weeks 1, 6, 10, and 18

Study Arms (3)

Formal mindfulness instruction

EXPERIMENTAL

Behavioral: Formal mindfulness instruction

Informal mindfulness instruction

EXPERIMENTAL

Behavioral: Informal mindfulness instruction

Inactive control

NO INTERVENTION

An equal number of university students from all groups will participate in this arm (i.e., those with ADHD, those with a history of nonsuicidal self-injury, and those with self-reported stress). Participants assigned to the inactive control condition will not complete any tasks during the four-week intervention period.

Interventions

Formal mindfulness instruction BEHAVIORAL

An equal number of university students from all groups will participate in this arm (i.e., those with ADHD, those with a history of nonsuicidal self-injury, and those with self-reported stress). The formal mindfulness instruction will consist of four weekly 1 hour-long group sessions, held on Webex (i.e., online) over four consecutive weeks. Participants will learn foundational principles around the role of mindfulness in relation to emotion regulation, stress, and self-compassion. They will also be taught formal mindfulness practices (e.g., sitting meditation, body scan, thought meditation, loving-kindness meditation) during the group sessions and will be asked to commit to practicing the strategies independently throughout the project period.

Formal mindfulness instruction

Informal mindfulness instruction BEHAVIORAL

An equal number of university students from all groups will participate in this arm (i.e., those with ADHD, those with a history of nonsuicidal self-injury, and those with self-reported stress). The informal mindfulness instruction will consist of four weekly 1 hour-long group sessions, held on Webex (i.e., online) over four consecutive weeks. Participants will learn foundational principles around the role of mindfulness in relation to emotion regulation, stress, and self-compassion. They will also be taught how to integrate informal mindfulness into their daily routine and will be guided through a series of demonstrations within the group sessions. Participants will be asked to commit to practicing informal mindfulness independently throughout the project period.

Informal mindfulness instruction

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Current student at McGill University or Concordia University
• years old
• Either self-reported stress or self-reported ADHD or a self-reported history of engaging in NSSI on at least 5 separate days in the last year

You may not qualify if:

• Having a history of NSSI that does not fulfill the recency/frequency requirement

Sponsors & Collaborators

• McGill University: lead
• Concordia University, Montreal: collaborator
• University of Ottawa: collaborator
• University of Toronto: collaborator

Study Sites (2)

Concordia University

Montreal, Quebec, Canada

Location

McGill University

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Self-Injurious Behavior; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nancy L. Heath, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished James McGill Professor

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: September 6, 2023
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (2)