MBI for Psychological Distress, SI and NSSI Among Young Adults

NCT06263335 | Completed DMC

• 1 other identifier: Fatima Jinnah Women University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychological Distress; Suicidal Ideation; Non-Suicidal Self Injury

Keywords

Mindfulness Based Intervention; Psychological Distress; Suicidal Ideation; Non-Suicidal Self Injury

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Interventional Group (Receiving Mindfulness Based Intervention)

EXPERIMENTAL

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

Control Group (No Intervention)

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.

Interventions

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.

Interventional Group (Receiving Mindfulness Based Intervention)

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatima Jinnah Women University: lead

Study Sites (1)

Fatima Jinnah Women University

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Suicidal Ideation; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Suicide; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 16, 2024
• Study Start: February 28, 2022
• Primary Completion: May 28, 2022
• Study Completion: May 28, 2022
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: When research is published.
• Access Criteria: Through open access journal publications.

Locations

PA (1)