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Nonsuicidal Self-injuryNCT05608304

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

A study testing Formal mindfulness induction and Informal mindfulness induction in people with Nonsuicidal Self-injury and Mindfulness, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 29 yearsHealthy volunteers can take part
Conditions the study is for
Nonsuicidal Self-injury, Mindfulness, Stress
What is being tested?
Formal mindfulness induction and Informal mindfulness induction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
1 siteCanada
Study dates
8 Nov 2022to 16 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Current student at the host institution
  • 18-29 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McGill University

    Montreal, Quebec, H3A 0G4

Other trials in Canada

About this study

Official title: The Effectiveness and Acceptability of Formal Versus Informal Mindfulness Among University Students With and Without Recent Nonsuicidal Self-injury: An Online, Parallel-group, Randomized Controlled Trial

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.

Read the detailed description

As university students have reported increasing levels of stress and difficulty coping with the challenges of university, student services have had to consider alternative approaches to meet the demand for student support. Thus, universities have moved beyond traditional mental health services to instructional, resilience-building approaches to enhance students' resilience and coping capacity. Mindfulness is a common foundation of these approaches due to the substantial evidence demonstrating the mental health and well-being benefits of mindfulness in university students. However, subgroups within the university student population may respond differently to standard mindfulness instruction.

Specifically, research suggests that university students who engage in non-suicidal self-injury (NSSI; the deliberate destruction of one's bodily tissue in the absence of lethal intent) may respond to mindfulness practice differently than students without such a history. Students with a history of NSSI are particularly prone to experiencing challenges in terms of stress, coping, and well-being in the university context. Thus, these students stand to benefit greatly from mindfulness-based programming that is adapted to their needs.

Standard mindfulness instruction generally consists of a combination of formal and informal practice. Formal practices can be conceptualized as structured, sustained attentional guided activities in which mindfulness is practiced within an allotted period of time (e.g., sitting meditation, body scan), whereas informal practices are brief and unstructured, and focus on the experience of one's senses during routine activities (e.g., becoming aware of the feeling of water on one's hands while washing them). Formal practice often requires sustained attention on one's inner experience (i.e., thoughts and emotions) and bodily sensations. Thus, existing difficulties with emotion regulation, self-criticism, and a potentially complex relationship with their body may render this common component of formal mindfulness practice sub-optimally effective among students with a history of NSSI.

By contrast, informal mindfulness strategies that are brief and unstructured may be more appropriate for these students. Nevertheless, only a few studies have attempted to parse out the benefits of formal and/or informal practice, and the results suggest benefits of informal mindfulness that are distinct from formal mindfulness. Furthermore, a recent systematic review examining the benefits of informal mindfulness concluded that informal practices may be more acceptable among those already experiencing difficulties with emotion regulation (e.g., those with recent NSSI engagement). The need for additional studies exploring the potentially differential acceptability and effectiveness of formal and informal mindfulness instruction among groups with unique intrapersonal needs was underscored.

Thus, the present study will use an online, parallel-group, randomized controlled design to investigate group differences between students with and without a history of 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.

Primary (state mindfulness) and secondary (state stress, state well-being, and acceptability) outcomes will be assessed immediately pre- and post-intervention. It is hypothesized that university students with a history of NSSI will report greater improvements in state mindfulness, state stress, and state well-being (Hypothesis 1a; superiority) as well as greater acceptability (Hypothesis 2a; superiority) in the IM condition, compared to those in the FM and control conditions. University students with a history of NSSI are also expected to report greater improvements in state mindfulness, state stress, and state well-being (Hypothesis 1b; superiority) as well as greater acceptability (Hypothesis 2b; superiority) in the FM condition, compared to those in control condition. Conversely, university students without a history of NSSI are expected to report noninferior improvements in state mindfulness, state stress, and state well-being (Hypothesis 1c; noninferiority) and noninferior acceptability (Hypothesis 2c; noninferiority) in the IM condition, compared to those in the FM. However, these students are expected to report greater improvements in state mindfulness, state stress, and state well-being (Hypothesis 1d; superiority) as well as greater acceptability (Hypothesis 2d; superiority) in the IM and FM conditions, compared to those in the control condition.

Being tested
Formal mindfulness induction, Informal mindfulness induction, Active control task
Keywords
Nonsuicidal Self-injury, Mindfulness, Stress, Well-Being, University Students
Medical subject headings
Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Formal mindfulness inductionBehavioural

    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.

  • Informal mindfulness inductionBehavioural

    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.

  • Active control taskBehavioural

    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.

Study groups in NCT05608304
Study groupRoleWhat they receive
Formal mindfulness inductionExperimentalNot described
Receives: Behavioral: Formal mindfulness induction
Informal mindfulness inductionExperimentalNot described
Receives: Behavioral: Informal mindfulness induction
Active control taskActive comparatorNot described
Receives: Behavioral: Active control task

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Pre-post intervention (10-minute interval)

Secondary outcomes (6)
  1. Change in state mindfulness (as measured by the FFMQ-24)

    An adaptation of the 24-item Five Facets of Mindfulness Questionnaire (FFMQ-24; Baer et al., 2006; Medvedev et al., 2018) will also be used to measure state mindfulness. Similar to the original FFMQ-24, this questionnaire will consist of five subscales each assessing a specific facet of state mindfulness (observing, describing, acting with awareness, non-judgmental acceptance, and non-reactivity), although items will be adapted to represent experiences in the present moment (rather than more generally). Respondents will be asked to rate each item on a 5-point Likert scale (1 = Not true at all to 5 = Very true). Items will include, "I am 'running on automatic' without much awareness of what I'm doing," and, "I could easily find the words to describe my feelings." Higher scores on each of the adapted FFMQ-24 subscales indicate greater levels of that specific facet of state mindfulness.

    Measured: Pre-post intervention (10-minute interval)

  2. Change in state stress (as measured by the VAS)

    A VAS for stress (Lesage et al., 2012) will be used to assess state stress. This VAS will consist of a small, unmarked ruler with anchors labeled as "0 = Not stressed at all" and "10 = As bad as it could be." Participants will be asked to "Indicate how stressed you feel in this moment on the ruler below by dragging the slider." The scale yields a single subjective stress score from 0 to 10, where a higher VAS score indicates greater state stress.

    Measured: Pre-post intervention (10-minute interval)

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

    The 9-item Psychological Stress Measure (PSM-9; Lemyre \& Tessier, 2003) will also be used to assess state stress. The PSM-9 consists of items such as, "I feel calm," "I feel rushed; I do not seem to have enough time," and, "I feel stressed," rated on an 8-point Likert scale ranging from Not at all (1) to Extremely (8). For the purposes of this study, "in this moment" will be indicated as the timeframe of interest in order to ensure that participants are reporting their state of stress in-the-moment. A higher sum score on the PSM-9 indicates greater state stress.

    Measured: Pre-post intervention (10-minute interval)

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

    Similar to above, six VAS scales will be used to assess six aspects of state well-being (i.e., whether participants are feeling calm, good, focused, self-critical, distracted, frustrated). Participants will be asked to "Indicate how [calm/good/focused/self-critical/distracted/frustrated] you feel in this moment on the ruler below by dragging the slider" on four separate VAS scales. Each scale yields a single subjective score from 0 to 10, where a higher VAS score indicates greater state well-being (on that specific aspect).

    Measured: Pre-post intervention (10-minute interval)

  5. Acceptability (as measured by the TFA questionnaire)

    The Theoretical Framework of Acceptability (TFA) Questionnaire will be used to assess intervention acceptability (Sekhon et al., 2022). This measure assesses the seven components of the TFA (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy) which can help identify characteristics of interventions that may be improved (Sekhon et al., 2017). The TFA Questionnaire is adaptable and can be used to evaluate various healthcare interventions. It consists of seven items, each pertaining to one of the components listed above, as well as an eight item that assesses general acceptability. For this trial, the item pertaining to opportunity costs will be omitted as it was deemed not applicable. In its place, an eighth item was created and added to this measure, reflecting concerns around the participant's assigned intervention. All items are rated on 5-point scales; a higher mean score indicates greater acceptability.

    Measured: Post-intervention only (5 minutes)

  6. Acceptability (as measured by the IMI)

    Subscales of the Intrinsic Motivation Inventory (IMI; Ryan, 1982) will also be used to assess acceptability from a SDT-perspective, as the IMI is intended to assess participants' subjective experience of a target activity in experimental research. For the purposes of this study, four subscales of this measure will be included: interest/enjoyment (5 items; e.g., "I enjoyed doing this activity very much"), perceived competence (5 items; e.g., "I am satisfied with my performance on this activity"), perceived autonomy (6 items; e.g., "I believe I had some choice in how I went about doing this activity"), and value/usefulness (7 items; e.g., "I believe this activity could be of some value to me"). All items are rated on a 7-point Likert scale ranging from Not at all true (1) to Very true (7).

    Measured: Post-intervention only (5 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2022
  2. Study start8 Nov 2022
  3. Primary completion16 May 2023
  4. Study completion16 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05608304
Sponsor's protocol ID
435-2022-0426
Status last verified
May 2025
First submitted
6 Oct 2022
Last updated
6 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Formal mindfulness induction and Informal mindfulness induction in people with Nonsuicidal Self-injury and Mindfulness, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in state mindfulness (as measured by the VAS) (time frame: Pre-post intervention (10-minute interval)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.

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