Mindfulness Based Stress Reduction Intervention

Intervention Study Clinical Trial

— MBSR  

Official title:

Mindfulness Based Stress Reduction Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05653739
• Other study ID #: FJWU/EC/2022/46
• Status: Completed
• Phase: N/A
• Start date: February 25, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: Fatima Jinnah Women University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to find out the impact of Mindfulness based stress reduction intervention on psychosocial factors associated with distress tolerance and quality of life among youth . The study is conducted on the youth age ranging from 15-24 years from districts Mardan and Nowshera of KP. Standardized tools are used to screen highly vulnerable cohort for further intervention. Eligible participants who scored higher on psychological distress, vicarious traumatization, and low on distress tolerance and quality of life and show their consent were recruited for the Intervention Phase. Participants were assigned randomly to experimental and control groups in intervention phase. Participants in the experimental group were given Mindfulness Based Stress Intervention (MBSR) training in the settings conducive for research.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

Inclusion Criteria:

• The participants studying in different public and private sector higher education institutes of Mardan and Nowshera districts of KP.

• Participants who volunteer to participate were included.

• Participants with High psychological distress, and Vicarious Trauma.

• Participants with low distress tolerance and low quality of life.

Exclusion Criteria:

• Participants below 15 years or above 24 years i.e., the age range of youth (as recommended by WHO) will be excluded.

• Participants with any significant reported medical disease were also excluded.

Related Conditions & MeSH terms

• Intervention Study

Intervention

Behavioral:
• Mindfulness Based Stress Reduction Intervention
MBSR is Mindfulness based intervention designed by Kabat-Zinn (1990) in order to deal with the stress and other psychological issues among individuals. This has been very effective intervention across different cultures . In this 8 week intervention participants will be given some home tasks to practice for at least 40 minutes a day.

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, 

References & Publications (5)

Denollet J. DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med. 2005 Jan-Feb;67(1):89-97. doi: 10.1097/01.psy.0000149256.81953.49. — View Citation

Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667. — View Citation

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. — View Citation

Motta RW, Kefer JM, Hertz MD, Hafeez S. Initial evaluation of the Secondary Trauma Questionnaire. Psychol Rep. 1999 Dec;85(3 Pt 1):997-1002. doi: 10.2466/pr0.1999.85.3.997. — View Citation

Simons,J.S., Gaher,R.M.(2005). The Distress Tolerance Scale: Development and Validation of a Self Report Measure. Motivation and Emotion,29,83-102. https://doi.org/10.1007/s11031-005-7955-3

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Psychological distress.	Psychological distress will be measured through Depression Anxiety and Stress Scale (DASS). After giving intervention to the participants it is expected that the participants will score low on the scale as low score is the indication of low level of psychological distress on DASS. Score above 32 will be considered as high level of psychological distress while score below 32 will be considered as indication of low level of psychological distress	Psychological distress will be measured before giving the intervention and at 8 weeks of intervention again the scale will be administered to measure psychological distress in order to check changes.
Primary	Changes in Vicarious Trauma	Vicarious Trauma will be measured through Secondary Stress Trauma Questionnaire. Individuals scoring above 44 on the scale is the indication of high level of secondary traumatic symptoms.	The time frame for the completion of intervention is 8 weeks after which it is expected that participants will score low on STQ.
Primary	Change in Distress Tolerance	Distress Tolerance will be measured through Distress Tolerance Scale (DTS).Low scores on the scale is the indication of higher level of distress tolerance. So score above 34 will be selected for participants to be recruited for study.	The time frame for the completion of intervention is 8 weeks after which it is expected that participants will score low on DTS i.e., their distress tolerance will be improved.
Primary	change in Quality of Life	Quality of life will be measured through The World Health Organization Quality of Life Scale (WHOQOL-BREF). High scores on the scale is the indication of high level of quality of life. Individuals scoring above 62 on the scale will be considered as scoring high on QOL for the current study. After participants are exposed to the intervention they will score higher on WHOQOL-BREF which means high quality of life.	The time frame for the completion of intervention is 8 weeks after which it is expected that participants will score high on WHOQOL-BREF.