Mindfulness for Stress and Well-being in University Students

NCT05216445 | Completed

• 1 other identifier: 0098/Ethic/01/S3H/008/DBS
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Well-being

Keywords

Mindfulness; stress; well-being; students

Outcome Measures

Primary Outcomes (14)

• Feasibility- recruitment method

  The number of participants recruited by each of the four methods used for recruiting. The four methods will be: social media and student groups, university platforms, referrals and recommendations and direct email to students. The barriers and facilitators in each method will evaluated by the recruiters.

  3 months

• Feasibility-recruitment rate

  Recruitment rate will be assessed through the number of participants who registered, number of participants screened through eligibility criteria, number of participants who start the training.

  3 months

• Feasibility of videoconferencing

  The assessment of barriers in technology including number of participants unable to attend sessions due to connectivity issues, number of participants dropped during sessions due to technical problems, number and type of problems, the number of participants seek extra time due to technical problems. The utility of zoom videoconferencing functions.

  3 months

• Feasibility-flexible multiple weekly online sessions

  The assessment of difficulties in conducting a multiple group format on both Saturday and Sunday for each weekly online session.

  2 months

• Feasibility- eligibility criteria

  Assessed through number of participants fulfilling the eligiblity criteria from the total number of students registered, number of ineligible participants and reasons for ineligibility.

  3 months

• Videoconferencing - acceptability by students

  The acceptability of videoconferencing by students will be assessed in terms of ease of use (1=not at all, 5= very much; post-intervention survey), interference of technical problems (1=not at all, 5= very much; post-intervention survey), advantages and disadvantages, overall satisfaction (1=poor, 5=excellent; post-intervention survey), suggestions for improvement (feedback interview)

  3 months

• Acceptability - Attrition rates

  The number of participants who complete the training and assessments, number of participants who withdraw and drop out, reasons for withdrawal and dropout.

  3 months

• Acceptability -participant attendance in weekly online sessions

  Average number of sessions attended by participants, reasons for missing sessions

  2 months

• Acceptability-Home practice

  Number of participants who submit weekly worksheets, average number of worksheets submitted by participants, the different tasks completed, time spent in home practice (post-training survey).

  2 months

• Acceptability of mindfulness training by students- semi-structured interview

  The interview will explore students' overall satisfaction with the adapted MBI, their perception of any possible facilitators and barriers in taking part in the adapted MBI, any system changes experienced (including familial and community relationships), any physical/ psychological adverse effects or benefits experienced during and after the adapted MBI, the students' view about the mindfulness exercises and daily tasks used in the adapted mindfulness-based intervention, the group format, the home practice, any suggestions for improvement.

  3 months

• Feasibility of conducting the trial -randomization

  The types and number of difficulties in randomization.

  3 months

• Acceptability of randomization

  The number of participants who consented for randomization, number of participants who refused, number of participants who changed their group, reasons for refusal and change of group.

  3 months

• Feasibility of online data collection

  The procedures of outcome measures data collection procedures, and online feedback interviews

  3 months

• Feasibility- outcome measures

  Feasibility of outcome measures will be assessed through the assessment completion rates by participants.

  3 months

Secondary Outcomes (3)

• Psychological well-being Scale

  baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention

• Five Facet Mindfulness Questionnaire

  baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention

• Clinical Outcomes Routine Evaluation-Outcome Measure

  baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention

Study Arms (2)

Mindfulness Training

EXPERIMENTAL

The participants in this group will receive the training for 8 weeks, with 60 minute online weekly sessions. The first session will be for 90 minutes.

Behavioral: Mindfulness Training

Wait-list Control

NO INTERVENTION

The wait-list control group will not receive any intervention. Once the study has been completed they will be offered the Mindfulness Training course.

Interventions

Mindfulness Training BEHAVIORAL

The Mindfulness Training will be an 8-week course, with group-based online weekly sessions. The mindfulness training, translated and adapted in Urdu, includes 8 guided audio meditations and one introductory audio recording which gives the participants an overview and introduction of the forthcoming 8-week training (e.g what mindfulness is, some common terms used repeatedly). It also includes 8 chapters, corresponding to each week and a workbook to record home practice. The training will start with an online group session after which the participants will be emailed the 1st week's reading material (chapter 1), audio recordings (for that week), home practice (for that week). At the start of every week, the participants will be emailed the required material for that week. Online sessions will be conducted weekly. The participants will also be sent poems and/or quotations relating to the week's theme and based on the session proceedings.

Mindfulness Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Science and Technology, Pakistan: lead

Study Sites (1)

National University of Science and Technology

Islamabad, Punjab Province, 44000, Pakistan

Location

Study Officials

• Salma Siddiqui

  National University of Science and Technology, Pakistan

  STUDY CHAIR

• Julieta Galante

  University of Cambridge, UK

  STUDY DIRECTOR

• Siham Sikandar

  National Institute of Health, Pakistan

  STUDY DIRECTOR

• Anum Sarfraz

  National University of Science and Technology, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The participants and intervention facilitator will be unaware at the time of allocation that which group they are being assigned to (sealed envelopes- a randomizing researcher different from the facilitator will generate the sequences and assign an ID(1-50) to one of the groups based on the sequence). The sealed envelopes will be given to the facilitator who will open the envelope in the interview and inform the participants about their allocated group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 19, 2021
• First Posted: January 31, 2022
• Study Start: February 1, 2022
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)