MBI for Psychological Distress, SI and NSSI Among Young Adults

NCT ID: NCT06263335

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-05-28

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.

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

Conditions

Psychological Distress; Suicidal Ideation; Non-Suicidal Self Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction Intervention

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fatima Jinnah Women University

OTHER

Sponsor Role: lead

Responsible Party

Sadia Sohail

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fatima Jinnah Women University

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Fatima Jinnah Women University

Identifier Type: -

Identifier Source: org_study_id