Physical DisabilityNCT06512844
MBSR for Improving Emotional Intelligence in Adolescents With Physical Disability
A study testing Mindfulness Based Stress Reduction (MBSR) Intervention in people with Physical Disability, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Physical Disability
- What is being tested?
- Mindfulness Based Stress Reduction (MBSR) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 12 May 2024to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The study would have the following inclusion criteria for participant recruitment.
- Adolescents with physical disability including:
- 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.
Who cannot join
- Exclusion Criteria The study would have the following inclusion criteria for participant recruitment.
- 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:
- Fully visual impairment ii. Hearing impairment iii. Deaf-blindness iv. Severe psychiatric issue
- Also, participant with any chronic or comorbid disease will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Mindfulness Based Intervention for the Management of Psychosocial Factors Associated With Emotional Intelligence in Adolescents With Physical Disability: a Randomized Control Trial
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
Read the detailed description
Title: The Efficacy of Mindfulness-Based Intervention for the Management of Psychosocial Factors Associated with Emotional Intelligence in Adolescents with Physical Disability: A Randomized Control Trial
Objective: 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.
Main Questions:
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?
Study Design:
Participants: Adolescents aged 10-18 years with a diagnosed physical disability.
Intervention: Mindfulness-based intervention (MBI) compared to a control group receiving no intervention.
Duration: 8 weeks Follow-Up: Participants will be assessed at baseline, mid-intervention (4 weeks), immediately post-intervention (8 weeks), and at a 3-month follow-up.
Methodology:
Participants will be randomly assigned to one of two groups:
Intervention Group: Will participate in the mindfulness-based intervention, which includes weekly mindfulness sessions and daily mindfulness practices at home.
Control Group: Will not receive any intervention but will continue with their usual activities along with some breathing exercises by the researcher.
Procedures:
Mindfulness Sessions: Weekly group sessions led by a trained mindfulness instructor, focusing on techniques such as meditation, breathing exercises, and body awareness.
Daily Practice: Participants in the intervention group will be instructed to practice mindfulness techniques daily and will receive support materials (e.g., audio recordings, practice guides).
Assessment:
Emotional Intelligence: Measured using the Schulte Self-Report Emotional Intelligence Test (SSEIT) at all assessment points.
Psychosocial Factors: Evaluated using standardized questionnaires such as the Child and Adolescent Trauma Screen (CATS) and the Depression, Anxiety, and Stress Scales (DASS).
Adverse Effects: Monitored through regular check-ins and a diary where participants can record any negative experiences.
Visit Schedule:
Baseline Visit: Initial assessment and randomization. Weekly Check-ins: Short visits or calls to monitor progress and adherence. Mid-Intervention (4 weeks): Comprehensive assessment of EI and psychosocial factors.
Post-Intervention (8 weeks): Final assessment of EI and psychosocial factors, collection of feedback on the intervention.
3-Month Follow-Up: Long-term assessment of sustained effects.
Participant Responsibilities:
Attend Weekly Sessions: Attend all scheduled mindfulness sessions. Daily Practice: Engage in daily mindfulness exercises and record their practice.
Keep a Diary: Maintain a diary or emotional response log of their emotional state, psychosocial experiences, and any adverse effects.
Outcome Measures:
Primary Outcome: Improvement in emotional intelligence as measured by SSEIT scores.
Secondary Outcomes:
Reduction in psychosocial distress as indicated by DASS scores. Improvement in trauma-related symptoms as measured by CATS. Monitoring and documentation of any adverse effects. Significance: 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.
- Conditions
- Physical Disability
- Being tested
- Mindfulness Based Stress Reduction (MBSR) Intervention
- Keywords
- emotional intelligence, mindfulness, physical disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction (MBSR) InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start12 May 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleeza Sohail, Fatima Jinnah Women University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512844
- Sponsor's protocol ID
- AleezaUW
- Status last verified
- Jul 2024
- First submitted
- 29 Jun 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Mindfulness Based Intervention for the Management of Psychosocial Factors Associated With Emotional Intelligence in Adolescents With Physical Disability: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06512844
- Acronym / sponsor ID
- AleezaUW
- Conditions
- Physical Disability
- Keywords
- emotional intelligence, mindfulness, physical disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 12 May 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Title: The Efficacy of Mindfulness-Based Intervention for the Management of Psychosocial Factors Associated with Emotional Intelligence in Adolescents with Physical Disability: A Randomized Control Trial
Objective: 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.
Main Questions:
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?
Study Design:
Participants: Adolescents aged 10-18 years with a diagnosed physical disability.
Intervention: Mindfulness-based intervention (MBI) compared to a control group receiving no intervention.
Duration: 8 weeks Follow-Up: Participants will be assessed at baseline, mid-intervention (4 weeks), immediately post-intervention (8 weeks), and at a 3-month follow-up.
Methodology:
Participants will be randomly assigned to one of two groups:
Intervention Group: Will participate in the mindfulness-based intervention, which includes weekly mindfulness sessions and daily mindfulness practices at home.
Control Group: Will not receive any intervention but will continue with their usual activities along with some breathing exercises by the researcher.
Procedures:
Mindfulness Sessions: Weekly group sessions led by a trained mindfulness instructor, focusing on techniques such as meditation, breathing exercises, and body awareness.
Daily Practice: Participants in the intervention group will be instructed to practice mindfulness techniques daily and will receive support materials (e.g., audio recordings, practice guides).
Assessment:
Emotional Intelligence: Measured using the Schulte Self-Report Emotional Intelligence Test (SSEIT) at all assessment points.
Psychosocial Factors: Evaluated using standardized questionnaires such as the Child and Adolescent Trauma Screen (CATS) and the Depression, Anxiety, and Stress Scales (DASS).
Adverse Effects: Monitored through regular check-ins and a diary where participants can record any negative experiences.
Visit Schedule:
Baseline Visit: Initial assessment and randomization. Weekly Check-ins: Short visits or calls to monitor progress and adherence. Mid-Intervention (4 weeks): Comprehensive assessment of EI and psychosocial factors.
Post-Intervention (8 weeks): Final assessment of EI and psychosocial factors, collection of feedback on the intervention.
3-Month Follow-Up: Long-term assessment of sustained effects.
Participant Responsibilities:
Attend Weekly Sessions: Attend all scheduled mindfulness sessions. Daily Practice: Engage in daily mindfulness exercises and record their practice.
Keep a Diary: Maintain a diary or emotional response log of their emotional state, psychosocial experiences, and any adverse effects.
Outcome Measures:
Primary Outcome: Improvement in emotional intelligence as measured by SSEIT scores.
Secondary Outcomes:
Reduction in psychosocial distress as indicated by DASS scores. Improvement in trauma-related symptoms as measured by CATS. Monitoring and documentation of any adverse effects. Significance: 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Behavioral: Mindfulness Based Stress Reduction (MBSR) InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- The study would have the following inclusion criteria for participant recruitment.
Key exclusion criteria (6 listed)
- Exclusion Criteria The study would have the following inclusion criteria for participant recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) InterventionThe 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 | Behavioural | Interventional Group |
Primary outcome
Emotional Intelligence
Time frame: 8 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction (MBSR) Intervention in people with Physical Disability, run by Fatima Jinnah Women University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Intelligence (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.