Clinical trial NCT05653739: Mindfulness Based Stress Reduction Intervention
Official title: Mindfulness Based Stress Reduction Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention Study
Lead sponsor: Fatima Jinnah Women University
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Psychological distress.
timeFrame: 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.
measure: Changes in Vicarious Trauma
timeFrame: The time frame for the completion of intervention is 8 weeks after which it is expected that participants will score low on STQ.
measure: Change in Distress Tolerance
timeFrame: 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.
measure: change in Quality of Life
timeFrame: The time frame for the completion of intervention is 8 weeks after which it is expected that participants will score high on WHOQOL-BREF.
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fatima Jinnah Women University
state: Punjab
Study officials:
References:
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.
citation: 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.
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.
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
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.