Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05608304
Other study ID # 435-2022-0426
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2022
Est. completion date May 16, 2023

Study information

Verified date May 2023
Source McGill University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 254
Est. completion date May 16, 2023
Est. primary completion date May 16, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 29 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Having a history of NSSI that does not fulfill the recency/frequency requirement

Study Design


Intervention

Behavioral:
Formal mindfulness induction
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 induction
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 task
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.

Locations

Country Name City State
Canada McGill University Montréal Quebec

Sponsors (2)

Lead Sponsor Collaborator
McGill University Social Sciences and Humanities Research Council of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Pre-post intervention (10-minute interval)
Secondary 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. Pre-post intervention (10-minute interval)
Secondary 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. Pre-post intervention (10-minute interval)
Secondary 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). Pre-post intervention (10-minute interval)
Secondary 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. Post-intervention only (5 minutes)
Secondary 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). Post-intervention only (5 minutes)
See also
  Status Clinical Trial Phase
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Recruiting NCT04038190 - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course Phase 2
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Active, not recruiting NCT05998161 - Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout N/A
Completed NCT03728062 - Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT06405789 - The Effect of Yoga on Mindfulness and Perceived Stress N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Completed NCT05245409 - Stress, EEG, ECG, and Chiropractic N/A
Completed NCT04722367 - Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT06057883 - Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females Phase 2
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Completed NCT05312749 - The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students N/A
Completed NCT05623826 - Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager N/A
Completed NCT04013451 - The Kiss of Kindness Study II N/A