An Adapted Mindfulness-based Intervention for Stress Reduction and Psychological Well-being of University Students in Pakistan: a Pilot Randomized Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Acceptability - Attrition rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •enrolled in an undergraduate or postgraduate course in a university in Pakistan.
排除标准
- •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.
结局指标
主要结局
Acceptability - Attrition rates
时间窗: 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
时间窗: 2 months
Average number of sessions attended by participants, reasons for missing sessions
Feasibility- recruitment method
时间窗: 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-flexible multiple weekly online sessions
时间窗: 2 months
The assessment of difficulties in conducting a multiple group format on both Saturday and Sunday for each weekly online session.
Feasibility of videoconferencing
时间窗: 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.
Videoconferencing - acceptability by students
时间窗: 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-Home practice
时间窗: 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).
Feasibility of conducting the trial -randomization
时间窗: 3 months
The types and number of difficulties in randomization.
Acceptability of randomization
时间窗: 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-recruitment rate
时间窗: 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- eligibility criteria
时间窗: 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.
Feasibility of online data collection
时间窗: 3 months
The procedures of outcome measures data collection procedures, and online feedback interviews
Acceptability of mindfulness training by students- semi-structured interview
时间窗: 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- outcome measures
时间窗: 3 months
Feasibility of outcome measures will be assessed through the assessment completion rates by participants.
次要结局
- 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)
研究者
Anum Sarfraz
Principle Investigator
National University of Science and Technology, Pakistan