Mindfulness for Stress and Well-being in University Students

NCT ID: NCT05216445

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-04-30

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.

Conditions

Stress; Well-being

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness Training

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.

Group Type: EXPERIMENTAL

Mindfulness Training

Intervention Type: 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.

Wait-list Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness Training

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Science and Technology, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Anum Sarfraz

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salma Siddiqui

Role: STUDY_CHAIR

National University of Science and Technology, Pakistan

Julieta Galante

Role: STUDY_DIRECTOR

University of Cambridge, UK

Siham Sikandar

Role: STUDY_DIRECTOR

National Institute of Health, Pakistan

Anum Sarfraz

Role: PRINCIPAL_INVESTIGATOR

National University of Science and Technology, Pakistan

Locations

National University of Science and Technology

Islamabad, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

0098/Ethic/01/S3H/008/DBS

Identifier Type: -

Identifier Source: org_study_id