MBI for Psychological Distress, SI and NSSI Among Young Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation; Psychological Distress; Non-Suicidal Self Injury
• Intervention / Treatment: Other: Mindfulness Based Stress Reduction Intervention

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Fatima Jinnah Women University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Group (Receiving Mindfulness Based Intervention); after the young adults have been randomized into interventional and control groups based on high levels of psychological distress, SI and NSSI, n=30 participants from this group would receive the mindfulness based intervention.	Other: Mindfulness Based Stress Reduction Intervention; 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.
No Intervention: Control Group (No Intervention); A wait list control group of n=30 randomized participants from the initial cohort would be in this group and receive no intervention, until the trial is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Distress	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.	8-12 weeks
Suicidal Ideation	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.	8-12 weeks
Non-Suicidal Self-Injury (NSSI)	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.	8-12 weeks

Collaborators and Investigators

• Sponsor: Fatima Jinnah Women University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): May 28, 2022
• Study Completion (Actual): May 28, 2022

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Psychological Distress; Suicidal Ideation; Mindfulness Based Intervention; Non-Suicidal Self Injury
• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Suicidal Ideation; Self-Injurious Behavior
• Other Study ID Numbers: Fatima Jinnah Women University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Within the ethical considerations, results of research would be shared via research publications.
• IPD Sharing Time Frame: When research is published.
• IPD Sharing Access Criteria: Through open access journal publications.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No