Formal Versus Informal Mindfulness Among University Students With and Without Recent Nonsuicidal Self-injury

NCT05608304 | Completed

• 1 other identifier: 435-2022-0426
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will use a randomized controlled design to investigate group differences between students with and without a history of nonsuicidal self-injury (NSSI) in response to a single-session mindfulness induction across conditions (formal mindfulness induction, informal mindfulness induction, active control task) in terms of the intervention's acceptability and effectiveness. Effectiveness will be inferred via pre-post changes in state mindfulness, state stress, and state well-being.

Conditions

Nonsuicidal Self-injury; Mindfulness; Stress; Well-Being

Keywords

Nonsuicidal Self-injury; Mindfulness; Stress; Well-Being; University Students

Outcome Measures

Primary Outcomes (1)

• Change in state mindfulness (as measured by the VAS)

  A Visual Analogue Scale (VAS), an instrument commonly used in induction research (e.g., Hessler-Kaufmann et al., 2020), will also be used to assess the momentary experience of five mindfulness facets, as generally described by Baer et al. (2006). Specifically, there will be five researcher-developed VAS items (one for each facet of mindfulness), modelled on the items in the Five Facets of Mindfulness Questionnaire (FFMQ; Baer et al., 2006). Each VAS will consist of a small, unmarked ruler with anchors labeled as "0 = Not true at all" and "10 = Completely true." Instructions will read: "Please indicate the extent to which each statement below accurately reflects your experience in this moment on the corresponding ruler below by dragging the slider," for each of the five facets of mindfulness. Each scale will yield a single subjective state mindfulness facet score from 0 to 10, where a higher VAS score indicates greater state mindfulness (on that facet).

  Pre-post intervention (10-minute interval)

Secondary Outcomes (6)

• Change in state mindfulness (as measured by the FFMQ-24)

  Pre-post intervention (10-minute interval)

• Change in state stress (as measured by the VAS)

  Pre-post intervention (10-minute interval)

• Change in state stress (as measured by the PSM-9)

  Pre-post intervention (10-minute interval)

• Change in well-being (as measured by the VAS)

  Pre-post intervention (10-minute interval)

• Acceptability (as measured by the TFA questionnaire)

  Post-intervention only (5 minutes)

Study Arms (3)

Formal mindfulness induction

EXPERIMENTAL

Behavioral: Formal mindfulness induction

Informal mindfulness induction

EXPERIMENTAL

Behavioral: Informal mindfulness induction

Active control task

ACTIVE COMPARATOR

Behavioral: Active control task

Interventions

Formal mindfulness induction BEHAVIORAL

The formal mindfulness induction will consist of a 10-minute audio recording of a sitting meditation, guiding the participant to consciously and repeatedly bring their attention to their breath and inner experience with nonjudgmental acceptance.

Formal mindfulness induction

Informal mindfulness induction BEHAVIORAL

The informal mindfulness induction will consist of on-screen instructions guiding participants through the completion of four routine tasks (washing hands, drinking water, laying down, listening to music) with mindful awareness and acceptance over the course of 10 minutes.

Informal mindfulness induction

Active control task BEHAVIORAL

Participants assigned to the active control condition will be prompted to download a single-page document containing 100 letters, numbers, and symbols, and a grid of 100 boxes. Following along with a guided audio, participants will be instructed to place all of the characters in the grid in a specific order over the course of 10 minutes. A version of this task has been used in previous studies by our team (Carsley \& Heath, 2019; Petrovic et al., 2022) and has been shown not to impact mindfulness levels, and was thus deemed an appropriate neutral attention task for this study.

Active control task

Eligibility Criteria

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

You may qualify if:

• Current student at the host institution
• years old
• Either a history of engaging in NSSI on at least 5 separate days in the last year or no history of ever having engaged in NSSI

You may not qualify if:

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

Sponsors & Collaborators

• McGill University: lead
• Social Sciences and Humanities Research Council of Canada: collaborator

Study Sites (1)

McGill University

Montreal, Quebec, H3A 0G4, Canada

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Nancy L. Heath, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished James McGill Professor

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: November 8, 2022
• Study Start: November 8, 2022
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CA (1)