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

NCT03501914 | Completed DMC

• 1 other identifier: PILLMINDFULNESS001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intellectual Disability

Keywords

Care givers; Adults; Intellectual Disability; Mindfulness

Outcome Measures

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

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

Secondary Outcomes (1)

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

  Change in scores from Baseline to 12 Weeks

Study Arms (1)

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

Behavioral: Mindfulness

Interventions

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.

Mindfulness Based Intervention

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

Dar Ul Sakoon

Karachi, 75500, Pakistan

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Intellectual Disability

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mindfulness based intervention

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 18, 2018
• Study Start: April 25, 2018
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

PA (1)