NCT06512844

Brief Summary

This study aims to provide evidence on the effectiveness of mindfulness-based interventions in enhancing emotional intelligence and managing psychosocial challenges in adolescents with physical disabilities, potentially offering a valuable tool for improving their overall well-being. Does the mindfulness-based intervention improve emotional intelligence in adolescents with physical disabilities? Does the psychosocial factors like psychological distress, self-compassion improve during the intervention? Are there any adverse effects associated with the mindfulness-based intervention? Researcher will give intervention and compare the control and experimental group in Time 1 and Time 2 respectively

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

June 29, 2024

Last Update Submit

July 19, 2024

Conditions

Keywords

emotional intelligencemindfulnessphysical disability

Outcome Measures

Primary Outcomes (1)

  • Emotional Intelligence

    Improvement in emotional intelligence as measured by Schuttle Self Report Emotional Intelligence Test scores. The High Scores means more emotionally intelligent high Emotional Intelligence scores are typically above 123, average EI scores range from 90 to 122; and low EI scores are below 89 which means not that emotionally intelligent

    8 weeks

Study Arms (2)

Interventional Group

EXPERIMENTAL

Participants who were assigned to interventional group were exposed to Urdu adapted and translated mindfulness-based stress reduction training. These participants received 8 weeks of intervention.

Behavioral: Mindfulness Based Stress Reduction (MBSR) Intervention

Control/Wait list Group

NO INTERVENTION

Participant who were assigned to Control Group did not receive any Intervention although they just received some relaxation breathing exercises.

Interventions

The MBSR training program consist of 8-week group session with the duration of 45-60 minutes each. Participants of the experimental group were given Mindfulness based stress reduction intervention in which they practice different mindfulness techniques. Each week focused on motor, cognitive and emotional issues of students with physically disabled. All the techniques also included psycho education

Interventional Group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents with physical disability including:
  • i. Orthopedic impairment ii. Traumatic brain injury iii. Sensory disability (vocally mute and partial visually impaired)
  • Adolescents with physical disability in the age range 10-18
  • Rural and urban residents
  • Urdu, English and Punjabi speaking Participants who scored higher than cut off score on MAAS-A, DASS 21 SCS-SF, CATS and SSEIT in the phase I will be included in the phase II of the study i.e., Randomize control trail.

You may not qualify if:

  • Adolescents under age 10 and above 18
  • Adolescents who are not willing to participate or their guardians did not give permission will be excluded from the present study.
  • Adolescents with physical disability such as:
  • i. Fully visual impairment ii. Hearing impairment iii. Deaf-blindness iv. Severe psychiatric issue
  • Also, participant with any chronic or comorbid disease will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aleeza Sohail

Islamabad, Federal, 04403, Pakistan

Location

MeSH Terms

Interventions

Mindfulness-Based Stress ReductionMethods

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This clinical trial aims to evaluate the effectiveness of a mindfulness-based intervention (MBI) in managing psychosocial factors associated with emotional intelligence (EI) in adolescents with physical disabilities. It also seeks to assess the safety and overall impact of the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mphil Research Student

Study Record Dates

First Submitted

June 29, 2024

First Posted

July 22, 2024

Study Start

May 12, 2024

Primary Completion

June 24, 2024

Study Completion

June 24, 2024

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations