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Completed

NCT Number: NCT03501914

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

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.

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Key information

Conditions

Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dar Ul Sakoon

Karachi, 75500, Pakistan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Mindfulness

Behavioral

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.

Primary outcomes

  1. sessions log

    Time frame: 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

Secondary outcomes

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

    Time frame: Change in scores from Baseline to 12 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2018
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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