Trials / Completed
CompletedNCT03501914
A Pilot Trial of Mindfulness Based Intervention Program for People With Intellectual Disabilities in a Low Income Setting
Mindfulness Based Intervention for Individuals With Intellectual Disabilities and Their Care Givers: A Pilot Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Pakistan Institute of Living and Learning · Academic / Other
- Sex
- All
- Age
- 16 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Mindfulness | A mindfulness program based on mindfulness-based principles developed by colleagues in Manchester will be adapted to be accessible for people with intellectual disabilities (ID) in Pakistan. This intervention will be translated into Urdu afterwards focus group will be conducted to get the views from people with ID, thei care takers and other stake holders to adapt and culturally modify the program. It will include some mindfulness based exercises i.e.welcome \& introduction, exploring senses, its all in the mind, Mindful eating, breathing, soles of the feet, body scan, guided meditation, mindful stretching and walking. |
Timeline
- Start date
- 2018-04-25
- Primary completion
- 2019-01-25
- Completion
- 2019-01-25
- First posted
- 2018-04-18
- Last updated
- 2019-03-21
Locations
1 site across 1 country: Pakistan
Source: ClinicalTrials.gov record NCT03501914. Inclusion in this directory is not an endorsement.