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临床试验/NCT03501914
NCT03501914已完成不适用

Mindfulness Based Intervention for Individuals With Intellectual Disabilities and Their Care Givers: A Pilot Trial

Pakistan Institute of Living and Learning2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
sessions log

研究概览

简要总结

The proposed study is a pre-post intervention study to investigate the acceptability and feasibility of a mindfulness based program for people with intellectual disabilities and their caregivers in a low income setting in Pakistan.

详细描述

In Pakistan, prevalence of intellectual disability is 19.1/1000 severe intellectual disability and 65/1000 for mild level of intellectual disability. Disability not only affects the individual but also the family in general and caretaker specifically.

Several researches proved that parents of children with disabilities experience number of problems related to parenting stress. There is a dire need to develop feasible, cost-effective, community level interventions, that would augment existing healthcare systems.

Mindfulness as a relatively new therapeutic strategy, has not been practiced as far as individuals with intellectual disability are concerned. This study aims to explore the feasibility and acceptability of mindfulness-based strategies for individuals with intellectual disability and their care takers in improving their well-being. A sample of 12 participants will be recruited from rehabilitation centers. The study will be conducted in Karachi. The group intervention will consist of twelve sessions; approx. 90-minutes per session weekly. therapy logswill be used to measure feasibility and acceptability of the intervention and the full Psychological Therapies Outcome Scale - intellectual disabilities (PTOS)-ID (psychological distress and positive well-being scales) will be used as secondary outcome measure. In addition, the positive well-being section of the PTOS-ID will also be administered at session 3 and 6 as an interim measure of well-being.

Baseline assessment will be done following the consent. Post assessments will be conducted at the end of intervention (at 3 months).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years and above
  • Able to cope with 90 minute session (with 10 minute break)
  • Able to be in a group setting
  • Able to get to the location of the group
  • Able to attend most sessions
  • All abilities welcome (including individuals who may struggle with language comprehension/expression)
  • Able to attend with a consistent staff member/carer for all sessions.

排除标准

  • Unable to cope with 90 minute session (with 10 minute break)
  • Person struggles with proximity of others or bring in a group setting
  • If physically unwell (new onset of severe illness)
  • Inconsistent staff team/carers supporting person to sessions
  • Ongoing experience of trauma or symptoms of Post-Traumatic Stress Disorder

研究组 & 干预措施

Mindfulness Based Intervention

Experimental

Mindfulness principles based manualized intervention will be provided to the participants which is developed by colleagues in Manchester. This intervention will be adapted to be accessible for people having intellectual disability (ID) in Pakistan.Sessions will take place once-weekly for 12 weeks including an initial orientation session. It will include breathing, soles of the feet, body scan, guided meditation, mindful stretching and walking

干预措施: Mindfulness (Behavioral)

结局指标

主要结局

sessions log

时间窗: from start of intervention till end i.e., 12 Weeks

We aim to determine whether the mindfulness intervention would be feasible to deliver and acceptable to the participants measured through sessions log

次要结局

  • Psychological Therapies Outcome Scale for Intellectual Disabilities (PTOS-ID)(Change in scores from Baseline to 12 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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