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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06263335
Other study ID # Fatima Jinnah Women University
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 28, 2022
Est. completion date May 28, 2022

Study information

Verified date February 2024
Source Fatima Jinnah Women University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 28, 2022
Est. primary completion date May 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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 Design


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.

Locations

Country Name City State
Pakistan Fatima Jinnah Women University Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Fatima Jinnah Women University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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