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CompletedNCT03501914Updated Mar 21, 2019

A Pilot Trial of Mindfulness Based Intervention Program for People With Intellectual Disabilities in a Low Income Setting

An interventional study of Mindfulness in Intellectual Disability, sponsored by Pakistan Institute of Living and Learning. Completed at 1 site in Pakistan. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-03-21.

Sponsored by Pakistan Institute of Living and Learning · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Intellectual Disability

Keywords

  • Care givers
  • Adults
  • Intellectual Disability
  • Mindfulness
03

In context

Intellectual Disability

363 studies on the registry are indexed under Intellectual Disability; 103 are open to participants now.

This study's enrollment of 12 is below the median of 53 across 236 interventional studies indexed under Intellectual Disability.

Browse Intellectual Disability studies →

Lead sponsor

Pakistan Institute of Living and Learning is the lead sponsor of 59 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Mindfulness Based Intervention

    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

    Behavioral: Mindfulness

Interventions

  • BehavioralMindfulness

    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.

06

What researchers measure

Primary outcomes

  1. sessions log

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

    Time frame: from start of intervention till end i.e., 12 Weeks

Secondary outcomes

  1. Psychological Therapies Outcome Scale for Intellectual Disabilities (PTOS-ID)

    PTOS-D will be used to assess psychological distress and positive well being of the participants and caregivers. it is a 29 item scale with 16 questions (Measuring Psychological Distress: higher score indicates higher psychological distress) and 11 questions measuring positive well-being: higher scores indicates higher positive well-being. The other two questions: Q-12 and Q-13 does not contribute to the indexes.

    Time frame: Change in scores from Baseline to 12 Weeks

07

Study locations

1 site
  • Dar Ul Sakoon
    Karachi, 75500, Pakistan
08

References and documents

Publications

  • Chapman, M.J., Hare, D.J., Caton, S., Donalds, D., McInnis, E., & Mitchell, D. (2013). The use of mindfulness with people with intellectual disability: A systematic review and narrative analysis. Mindfulness, 4. Doi: 10.1007/s12671-013-0197-7.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03501914
Lead sponsor
Pakistan Institute of Living and Learning
Responsible party
Sponsor
First posted
Apr 18, 2018
Start date
Apr 25, 2018
Primary completion
Jan 25, 2019
Completion
Jan 25, 2019
Last update
Mar 21, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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