- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07694908
Psychosocial Correlates of Trait Emotional Intelligence and Psychosomatic Symptoms: A Randomized Controlled Trial of Mindfulness-Based Stress Reduction Among Adolescents Exposed to Bullying. (MBSR-RCT)
This study examines the psychosocial correlates of trait emotional intelligence and psychosomatic symptoms among adolescents exposed to bullying and analyzes the effetiveness of Mindfulness Based Stress Reduction (MBSR) program through a randomized controlled trial.
The study is two phased, in which the Phase 1 includes a cross sectional correlational survey that was administered to 403 adolescents aged 14 to 18 years studying in secondary schools and colleges of Rawalpindi and Islamabad, Pakistan to analyze the relationships among childhood traumatic experiences, mindfulness, and level of bullying exposure with trait emotional intelligence and psychosomatic symptoms to identify eligible participants for Phase 2.
In Phase 2, about 44 adolescents meeting eligibility criteria were randomly assigned to either an intervention group that received the 8 week MBSR intervention (n=22) or waitlist control group (n=22). Pre and post assessments were done to examine changes in trait emotional intelligence and psychosomatic symptoms, following the mbsr intervention.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Bullying exposure is a concerning issue, specially among adolescents. It often results in severe negative physical and psychological outcomes which also includes low emotional intelligence and increased psychosomatic symptoms. Although, there are many studies that have focused on observing the effectiveness of MBSR or Mindfulness based interventions for reducing stress and regulating emotions, but there are very limited studies that have examined these relationships or have tested MBSR as an intervention, solely for adolescents exposed to bullying.
The current study has a two phased quantitative research design:
Phase 1: Cross Sectional Correlational Survery In this phase, about 403 adolescents aged 14 to 18 years, currently studying in secondary schools and colleges of Rawalpindi and Islamabad, Pakistan were recruited through purposive convinient sampling. They completed a standardized questionnaire including scales such as, Multidimensional Peer Victimization Scale (MPVS-24), the Paediatric ACEs and Related Life Events Screener (PEARLS), the Mindful Attention Awareness Scale (MAAS), the Trait Emotional Intelligence Questionnaire Adolescents Short Form (TEIQue-ASF) and the DSM 5 Level 2 Somatic Symptom Scale for Children aged 11 to 17.
Phase 2: Randomized Controlled Trial Adolescents meeting the eligibility criteria based on Phase 1 screening were identified. These adolescents had scored at or above the 75th percentile on the MPVS-24, PEARLS and DSM 5 Level 2 Somatic Symptom indicating significant level of bullying exposure, childhood traumatic experiences and increased psychosomatic symptoms and at or below the 25th percentile on The MAAS and TEIQue-ASF showing low mindfulness and disturbed trait emotional intelligence.
About 44 adolescents that were found eligible were randomized using computer generated random numbers in spss either into interventio group (n=22) who received 8 week MBSR through online platform having 90 minutes sessions and a waitlist control group (n=22) who did not receive any intervention during the study period.
Assessor blinding was used throughout the process of data collection in which the research assistant administering assessments was kept unaware Of participants group assignments. Pre intervention baseline assesssments were conducted at Time 1 and post intervention assessements at Time 2.
After the completion of the study, the waitlist control group received the MBSR program.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Punjab Province
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Rawalpindi, Punjab Province, Pákistán, 46000
- Fatima Jinnah Women University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Adolescents aged 14 to 18 years currently enrolled in secondary school and colleges of Rawalpindi and Islamabad Pakistan.
Score at or above 75th percentile on Multidimensional Peer Victimization Scale (MPVS-24) indicating significant bullying exposure.
Score at or above 75th percentile on Pediatric ACEs and Related Life Events Screener (PEARLS) indicating Meaningful childhood trauma history.
Score at or below 25th percentile on Mindful Attention Awareness Scale (MAAS) Indicating low dispositional mindfulness.
Score at or below 25th percentile on Trait Emotional Intelligence Questionnaire Adolescent Short Form (TEIQue-ASF) indicating Impaired trait emotional intelligence.
Demonstrate increased psychosomatic symptoms on DSM-5 Level 2 Somatic Symptom Scale for Children aged 11 to 17.
Access to smartphone tablet or computer with stable Internet connection for online session participation.
Voluntary assent from participant and written informed consent from parent or guardian.
Exclusion Criteria:
Current diagnosis of severe Psychiatric disorder such as Psychotic disorder.
Currently receiving psychotherapy or any structured psychological treatment.
Currently taking psychiatric or Mental health medication.
Currently practicing mindfulness related exercises such as meditation Yoga or breathing exercises.
Diagnosed chronic physical illness.
Diagnosed physical or learning Disability.
Unwillingness to commit to attending all eight weekly Online MBSR sessions.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: MBSR Intervention Group
Participants assigned to this arm received 8 week sessions online of MBSR.
Each session was 90 minutes long and delivered through video conferencing.
Sessions included mindfulness meditation, breathing exercises, body scan practices and group discussions.
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8 week structured online group program based on the Kabat-Zinn 1990 protocol adapted for adolescents delivered via video conferencing in weekly 90 minute sessions comprising mindfulness meditation breathing exercises body scan Mindful movement and group Discussions to increase present moment awareness reduce stress reactivity improve Emotional stability.
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Žádný zásah: Waitlist Control Group
Participants in this arm, receieved no intervention during the study period and were given mbsr program after the study completion.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Trait Emotional Intelligence
Časové okno: Baseline pre intervention and 8 weeks post intervention
|
Measured using Trait Emotional Intelligence Questionnaire Adolescent Short Form (TEIQue-ASF), a 30 Item self report measure.
Higher scores indicate higher Trait emotional intelligence.
|
Baseline pre intervention and 8 weeks post intervention
|
|
Psychosomatic Symptoms
Časové okno: Baseline and 8 weeks
|
Measured using DSM-5 Level 2 Somatic Symptom Scale for children aged 11 To 17.
A 13 Item scale.
Higher scores Indicate greater psychosomatic distress.
|
Baseline and 8 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mindfulness
Časové okno: Baseline and 8 weeks
|
Measured through Mindful Attention Awareness Scale (MAAS).
A 15 item self report measure.
Higher scores indicate Greater dispositional mindfulness.
|
Baseline and 8 weeks
|
|
Level of Bullying Exposure
Časové okno: Baseline and 8 weeks
|
Measured using Multidimensional Peer Victimization Scale MPVS-24.
A 24 item measure.
Higher scores show greater bullying exposure.
|
Baseline and 8 weeks
|
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Childhood Traumatic Experiences
Časové okno: Baseline and 8 weeks
|
Measured using Pediatric ACEs And Related Life Events Screener (PEARLS).
Higher scores indicate greater adverse childhood Experiences
|
Baseline and 8 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Symptomy chování
- Agrese
- Patologické stavy, příznaky a symptomy
- Chování
- Příznaky a symptomy
- Společenské chování
- Obtěžování, nesexuální
- Šikanování
- Psychofyziologické poruchy
- Terapie chování
- Psychoterapie
- Disciplíny a činnosti chování
- Kognitivní behaviorální terapie
- Všímavost
- Snížení stresu založeného na všímavosti
Další identifikační čísla studie
- FJWU/EC/2026/147
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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