StressNCT05216445
Mindfulness for Stress and Well-being in University Students
A study testing Mindfulness Training in people with Stress and Well-being, run by National University of Science and Technology, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Well-being
- What is being tested?
- Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- enrolled in an undergraduate or postgraduate course in a university in Pakistan.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National University of Science and Technology
Islamabad, Punjab Province, 44000
About this study
Official title: An Adapted Mindfulness-based Intervention for Stress Reduction and Psychological Well-being of University Students in Pakistan: a Pilot Randomized Trial Protocol
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.
Read the 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
- Being tested
- Mindfulness Training
- Keywords
- Mindfulness, stress, well-being, students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 3 months
Acceptability -participant attendance in weekly online sessions
Average number of sessions attended by participants, reasons for missing sessions
Measured: 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).
Measured: 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.
Measured: 3 months
Feasibility of conducting the trial -randomization
The types and number of difficulties in randomization.
Measured: 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.
Measured: 3 months
Feasibility of online data collection
The procedures of outcome measures data collection procedures, and online feedback interviews
Measured: 3 months
Feasibility- outcome measures
Feasibility of outcome measures will be assessed through the assessment completion rates by participants.
Measured: 3 months
Secondary outcomes (3)
Psychological well-being Scale
Psychological well-being Scale is used as a measure of psychological well-being with six categories; autonomy, environmental mastery, personal growth, positive relations with others, purpose in life and self-acceptance. It consists of 42 items rated on a Likert scale ranging from 1=strongly disagree to 4=strongly agree. Higher scores indicate higher levels of psychological wellbeing.
Measured: baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention
Five Facet Mindfulness Questionnaire
Five Facet Mindfulness Questionnaire is used as a measure of dispositional mindfulness. It consists of 39 items rated on a Likert scale ranging from 1=never or very rarely true to 4=very often or always true. Higher scores indicate increase in mindfulness.
Measured: baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention
Clinical Outcomes Routine Evaluation-Outcome Measure
Clinical Outcomes Routine Evaluation-Outcome Measure is used as a measure of psychological distress. It consists of 34 items rated on a Likert scale ranging from 1=not at all to 4=most of the time. Higher scores indicate higher levels of psychological distress.
Measured: baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Feb 2022
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Science and Technology, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anum Sarfraz, National University of Science and Technology, Pakistan
- Investigators
- Salma Siddiqui, Study chair, National University of Science and Technology, PakistanJulieta Galante, Study director, University of Cambridge, UKSiham Sikandar, Study director, National Institutes of Health, PakistanAnum Sarfraz, Principal investigator, National University of Science and Technology, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216445
- Sponsor's protocol ID
- 0098/Ethic/01/S3H/008/DBS
- Status last verified
- May 2022
- First submitted
- 19 Dec 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adapted Mindfulness-based Intervention for Stress Reduction and Psychological Well-being of University Students in Pakistan: a Pilot Randomized Trial Protocol
- ClinicalTrials.gov ID
- NCT05216445
- Acronym / sponsor ID
- 0098/Ethic/01/S3H/008/DBS
- Conditions
- Stress, Well-being
- Keywords
- Mindfulness, stress, well-being, students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- National University of Science and Technology, PakistanUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training | Experimental | Behavioral: Mindfulness TrainingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- enrolled in an undergraduate or postgraduate course in a university in Pakistan.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness TrainingThe 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. | Behavioural | Mindfulness Training |
Primary outcome
Feasibility- recruitment method
Time frame: 3 months
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.
Feasibility-recruitment rate
Time frame: 3 months
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.
Feasibility of videoconferencing
Time frame: 3 months
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.
Feasibility-flexible multiple weekly online sessions
Time frame: 2 months
The assessment of difficulties in conducting a multiple group format on both Saturday and Sunday for each weekly online session.
Feasibility- eligibility criteria
Time frame: 3 months
Assessed through number of participants fulfilling the eligiblity criteria from the total number of students registered, number of ineligible participants and reasons for ineligibility.
Videoconferencing - acceptability by students
Time frame: 3 months
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)
Acceptability - Attrition rates
Time frame: 3 months
The number of participants who complete the training and assessments, number of participants who withdraw and drop out, reasons for withdrawal and dropout.
Acceptability -participant attendance in weekly online sessions
Time frame: 2 months
Average number of sessions attended by participants, reasons for missing sessions
Acceptability-Home practice
Time frame: 2 months
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).
Acceptability of mindfulness training by students- semi-structured interview
Time frame: 3 months
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.
Feasibility of conducting the trial -randomization
Time frame: 3 months
The types and number of difficulties in randomization.
Acceptability of randomization
Time frame: 3 months
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.
Feasibility of online data collection
Time frame: 3 months
The procedures of outcome measures data collection procedures, and online feedback interviews
Feasibility- outcome measures
Time frame: 3 months
Feasibility of outcome measures will be assessed through the assessment completion rates by participants.
3 secondary outcomes
Psychological well-being Scale
Time frame: baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention
Five Facet Mindfulness Questionnaire
Time frame: baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention
Clinical Outcomes Routine Evaluation-Outcome Measure
Time frame: baseline assessment before the delivery of intervention and after 8 weeks i.e the completion of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salma Siddiqui study chair
National University of Science and Technology, Pakistan
Julieta Galante study director
University of Cambridge, UK
Siham Sikandar study director
National Institutes of Health, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training in people with Stress and Well-being, run by National University of Science and Technology, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- recruitment method (time frame: 3 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.