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临床试验/NCT06263335
NCT06263335已完成不适用

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

Fatima Jinnah Women University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Suicidal Ideation

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Mindfulness Based Stress Reduction Intervention (Other)

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.

结局指标

主要结局

Suicidal Ideation

时间窗: 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.

Psychological Distress

时间窗: 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.

Non-Suicidal Self-Injury (NSSI)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sadia Sohail

Student

Fatima Jinnah Women University

研究点 (2)

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