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Completed

NCT Number: NCT06263335

MBI for Psychological Distress, SI and NSSI Among Young Adults

Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Those individuals who agree to participate in the trial and identified with high levels of psychological distress and Suicidal Ideation, randomly divided into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction intervention then administered to the interventional group for eight weeks and pre and post intervention assessment done for both the groups.

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Key information

Conditions

Psychological Distress Behavior Behavioral Symptoms Non-Suicidal Self Injury Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatima Jinnah Women University

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

Study assessment measures:

  • Informed consent form
  • Demographic questionnaire
  • Screener questions form
  • Assessment instruments:
  • Depression Anxiety and Stress Scale (DASS-21)
  • Suicide Ideation Scale (SIS)
  • Alexian Brothers Urge to Self Injure Scale (ABUSI)
  • Mindfulness Attention Awareness Scale

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants aged 18-24, of any gender, who consented to participate and could comprehend English (the language of the questionnaires).
  • Selected respondents from the initial survey were included based on specific criteria:
  • Willingness to continue participation.
  • Unmarried status.
  • Pursuing education (Bachelors, Masters, or Ph.D.) , Pakistan.
  • Non-hosteller and unemployed.
  • Residing with both parents.
  • Affirmative response to screener questions about suicidal ideation (SI) and non-suicidal self-injury (NSSI).
  • High scores on psychological distress and SI scales.

Exclusion criteria

  • Participants failing to meet inclusion criteria or falling under the following categories were excluded:
  • Non-students.
  • History of present or past psychiatric illness, with recent medication or treatment within the past year.
  • Presence of debilitating physical diseases or disabilities. Involvement in or history of substance use.
  • Long-term medication for any condition, as these factors could impact study results.

Treatment and study plan

Mindfulness Based Stress Reduction Intervention

Other

During an eight-week intervention period, clients were to engage in mindfulness practices lasting between 45 minutes to an hour each session. The intervention would incorporate various components of the Mindfulness-Based Stress Reduction (MBSR) program, including mindfulness of the present moment, body scans, mindful eating, walking meditation, yoga exercises, and discussions on applying mindfulness to everyday experiences and stress management. Sessions would typically range from 30 to 90 minutes per week, with an additional full-day retreat session towards the end of the program. In addition to mindfulness practice, participants were to receive teachings on stress management and its application to interpersonal and daily life situations.

Primary outcomes

  1. Psychological Distress

    Time frame: 8-12 weeks

    This refers to the overall level of emotional suffering or discomfort experienced by individuals, often encompassing symptoms of depression, anxiety, and stress. In this study, psychological distress serves as a primary outcome measure because it is a key variable being assessed in relation to the intervention's efficacy.

  2. Suicidal Ideation

    Time frame: 8-12 weeks

    Suicidal ideation involves thoughts or ideas about engaging in behaviors intended to end one's life. As a primary outcome measure, assessing suicidal ideation is crucial in understanding the impact of the intervention on the participants' mental health and risk of self-harm.

  3. Non-Suicidal Self-Injury (NSSI)

    Time frame: 8-12 weeks

    NSSI refers to deliberate, self-inflicted harm to one's body without suicidal intent, such as cutting or burning oneself. It is an essential primary outcome measure in this study because it directly relates to the intervention's effectiveness in reducing self-harming behaviors among participants.

Sponsors and collaborators

Lead sponsor

Fatima Jinnah Women University

Other

Registry information

Official study title

Impact of Mindfulness Based Therapeutic Intervention on Psychological Distress, Suicidal Ideation and Non-Suicidal Self Injury Among Young Adults: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2024
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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