Clinical trial NCT05216445: Mindfulness for Stress and Well-being in University Students
Official title: An Adapted Mindfulness-based Intervention for Stress Reduction and Psychological Well-being of University Students in Pakistan: a Pilot Randomized Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Well-being
Keywords: Mindfulness
stress
well-being
students
Lead sponsor: National University of Science and Technology, Pakistan
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In developing countries such as Pakistan, the challenges university students face are many-fold and there is a need for an intervention that helps build students' connection with themselves, utilizing their internal resources to deal with stresses. Mindfulness-based interventions have shown effectiveness with university students in high-income countries. The current study will be testing an adaptation for students of Pakistan of an intervention (Finding Peace in a Frantic World) which is based on principles from both Mindfulness-based cognitive therapy(MBCT) and Mindfulness-based stress reduction(MBSR). The purpose of this pilot trial is to assess the feasibility and acceptability (primary outcomes) of conducting a randomized controlled trial (RCT) of an adapted Mindfulness-based intervention with a wait-list control group for university students in Pakistan to reduce stress and enhance psychological well-being (N=50), which will inform the development of a future large-scale RCT. Keeping in view the COVID-19 lockdown and economic conditions in low-and-middle-income countries (LAMICs), an online program with a remote facilitator is deemed to be more cost-effective, approachable, practical, and de-stigmatizing for students.

Detailed description: In LAMICs, including Pakistan young adults comprise more than half of the total population (60%) many of them enrolled in universities (12.7% of the total young adult population) emphasizes the need for psychological interventions in these educational institutes.

Considering the substantial lack of a systematic approach in the development, adaptation, and implementation of mindfulness-based interventions the investigators of this study employed the first two steps of Medical Research Council Guidelines (MRC) for the development of complex interventions. This current study represents the final phase of the project, where the feasibility and acceptability of the Adapted Mindfulness Training will be assessed through a Pilot RCT. The participants will be randomly assigned to either the Mindfulness Training group or the wait-list control group. The participants in the Mindfulness Training group will have online 8-week training, with weekly online group video-conference sessions with the facilitator. Both groups will be asked to complete questionnaires for outcome measures (mindfulness, well-being and stress), one week before the training starts and one week after the training ends. At the end of the training semi-structured interviews about the training will be conducted with participants (from the Mindfulness Training) who consent. The study will examine key methodological uncertainties (recruitment methods, recruitment rate, retention rate, randomization procedures), explore the acceptability of the adapted intervention and calculation of appropriate sample sizes and preliminary responses to the intervention in order to inform a future large-scale RCT. Acceptability here refers to the assessment of whether the university students find it appropriate and according to their needs and culture. To the investigator's knowledge, there haven't been any RCTs that studied the effectiveness of an online Mindfulness training translated in Urdu and adapted for university students in Pakistan to reduce stress and enhance well-being.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* enrolled in an undergraduate or postgraduate course in a university in Pakistan.

Exclusion Criteria:

* suffering from any current diagnosed severe mental illnesses including severe depression, anxiety, hypomania, or psychotic illness
* suffering from any severe medical illness.

The criteria will be self-reported by the students at the time of registration for the training.

Primary outcomes:
measure: Feasibility- recruitment method
timeFrame: 3 months
measure: Feasibility-recruitment rate
timeFrame: 3 months
measure: Feasibility of videoconferencing
timeFrame: 3 months
measure: Feasibility-flexible multiple weekly online sessions
timeFrame: 2 months
measure: Feasibility- eligibility criteria
timeFrame: 3 months
measure: Videoconferencing - acceptability by students
timeFrame: 3 months
measure: Acceptability - Attrition rates
timeFrame: 3 months
measure: Acceptability -participant attendance in weekly online sessions
timeFrame: 2 months
measure: Acceptability-Home practice
timeFrame: 2 months
measure: Acceptability of mindfulness training by students- semi-structured interview
timeFrame: 3 months
measure: Feasibility of conducting the trial -randomization
timeFrame: 3 months
measure: Acceptability of randomization
timeFrame: 3 months
measure: Feasibility of online data collection
timeFrame: 3 months
measure: Feasibility- outcome measures
timeFrame: 3 months
Secondary outcomes:
measure: Psychological well-being Scale
timeFrame: baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention
measure: Five Facet Mindfulness Questionnaire
timeFrame: baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention
measure: Clinical Outcomes Routine Evaluation-Outcome Measure
timeFrame: baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: National University of Science and Technology
state: Punjab
Study officials:
affiliation: National University of Science and Technology, Pakistan
name: Salma Siddiqui
role: STUDY_CHAIR
affiliation: University of Cambridge, UK
name: Julieta Galante
role: STUDY_DIRECTOR
affiliation: National Institute of Health, Pakistan
name: Siham Sikandar
role: STUDY_DIRECTOR
affiliation: National University of Science and Technology, Pakistan
name: Anum Sarfraz
role: PRINCIPAL_INVESTIGATOR
References: