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Completed

NCT Number: NCT06988800

Musically-Guided Paced Breathing Improves Mental Health in War-Affected Adolescents

Examine the impact of a mindfulness condition, a guided paced breathing audiovisual intervention condition, and a guided paced breathing audiovisual intervention plus take-home application condition compared to a matched control condition on anxiety symptoms.

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Key information

Conditions

Anxiety Anxiety Disorders Depression Not Otherwise Specified Mental Disorders Self-Efficacy

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MECI

Deir Ghassaneh, West Bank, Palestinian Territories

About this study

Methodology:

Sample and population

Individuals will be eligible if they attend the after-school program in Palestine through the Middle East Children's Institute (MECI) and are in grades 9-12. The MECI after school program is a free enrichment service provided to Palestinian youth at no charge. The activities include healthy meals, psychosocial support, creative art, sports, and drama.

Study setting The Middle East Children's Institute after-school program in Palestine.

Recruitment All eligible adolescents will be given information about the study (including that it is optional and voluntary) and provided with a consent form to bring home to their parents. Study staff will follow-up with the families of potentially eligible adolescents up to three times to ask if they have questions about the study and/or to remind them to return the signed consent form if they would like to participate.

Study duration Each intervention will have 14 sessions, delivered 2 times a week for 5 weeks in a group format in school classrooms, and an additional 2 weeks following a one month Ramadan period with no intervention delivered. Each group will consist of approximately 10 adolescents, and each intervention will have a duration of approximately less than 10 minutes long. Multiple sessions will be necessary to complete all assessments before and after the intervention.

Data collection and tools

There will be several non-invasive survey instruments utilized in this study.

Demographics. At baseline, participants will complete an investigator-developed self-report questionnaire that asks about participant age and gender identity.

Anxiety. As the primary outcomes measure, participants will complete the Revised Children's Manifest Anxiety Scale (RCMAS) self-report questionnaire. The RCMAS lists 37 feelings or actions and participants respond "yes" if that item is typical of their own feelings/actions, or "no" if not. The RCMAS produces a total anxiety score and three subscales: physiological anxiety, worry/oversensitivity, and social concerns/concentration. The Arabic version of the RCMAS has shown to have acceptable reliability and validity in youth.

Self-Efficacy. As a secondary outcome measure, a translated version of the Self-Efficacy Questionnaire for Children (SEQ-C) will be used. The SEQ-C includes three 8-item scales that measure academic, social, and emotional self-efficacy. The academic self-efficacy scale includes questions about the person's perception of achieving academic goals. The social self-efficacy scale addresses social challenges, and the emotional self-efficacy scale includes questions about coping with unpleasant problems or events.

Depression. As a secondary outcome measure, depression will be measured by the translated PHQ (Patient Health Questionnaire) -9.

Incentives for participants

Participants will receive no financial or other compensation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Participating in MECI after school program and between the ages of 13 and 17.

Exclusion criteria

Not participating in MECI after school program or outside of the ages of 13 and 17.

Treatment and study plan

Paced breathing wellness breathing sessions

Device

The paced breathing condition used timed auditory and visual cues to guide participants through breathing cycles at a rate of five breaths per minute, designed to stimulate the parasympathetic nervous system and promote relaxation. The audiovisual cues included spoken instructions, music, and breath-like sounds. The tonal audio cues rose in pitch during inhalation and fell during exhalation, creating a clear auditory signal for breath pacing. The same harmonic drone used in the mindfulness intervention provided a calming background, though here it was combined with the rhythmic pacing. Visually, the pacing was synchronized with the image of a lotus flower opening during inhalation and closing during exhalation, reinforcing the breathing rhythm.

Mindfulness video sessions

Device

The audio component of the mindfulness intervention featured a female narrator guiding participants through mindfulness exercises, focusing on breath awareness and cultivating non-judgmental attention to thoughts and feelings. Ambient tonal sounds, including a harmonic drone with slow timbral changes, played softly in the background to support relaxation. Importantly, no rhythmic audio cues were included to avoid inducing breathing entrainment. This setup emphasized passive, mindful observation rather than active breath control, encouraging participants to observe their bodily sensations and thoughts without judgment.

Primary outcomes

  1. Revised Children's Manifest Anxiety Scale (RCMAS)

    Time frame: From enrollment to the end of treatment at 12 weeks

    As the primary outcomes measure, participants will complete the Revised Children's Manifest Anxiety Scale (RCMAS) self-report questionnaire. The RCMAS lists 37 feelings or actions and participants respond "yes" if that item is typical of their own feelings/actions, or "no" if not. The RCMAS produces a total anxiety score and three subscales: physiological anxiety, worry/oversensitivity, and social concerns/concentration. The Arabic version of the RCMAS has shown to have acceptable reliability and validity in youth.

    The score ranges from 0-37, with a higher score indicating greater anxiety.

  2. Self-Efficacy Questionnaire for Children (SEQ-C)

    Time frame: From enrollment to the end of treatment at 12 weeks

    As a secondary outcome measure, a translated version of the Self-Efficacy Questionnaire for Children (SEQ-C) will be used. The SEQ-C includes three 8-item scales that measure academic, social, and emotional self-efficacy. The academic self-efficacy scale includes questions about the person's perception of achieving academic goals. The social self-efficacy scale addresses social challenges, and the emotional self-efficacy scale includes questions about coping with unpleasant problems or events.

    The subscale totals are added for a total score, ranging from 0-72, with a higher score being a positive indicator of greater self-efficacy.

  3. Patient Health Questionnaire 9 (PHQ-9)

    Time frame: From enrollment to the end of treatment at 12 weeks

    A validated measure of depressive symptoms, consisting of nine items assessing the frequency of depressive symptoms over the past two weeks. The PHQ-9 has demonstrated strong psychometric properties, including reliability and validity in clinical and non-clinical populations, including the translated Arabic version.

    Scores range from 0-27, with a higher score indicating more depressive symptoms.

Sponsors and collaborators

Lead sponsor

Muvik Labs

Industry

Collaborators

  • MECI

Registry information

Official study title

A Randomized Controlled Trial Examining the Impact of a Guided Paced Breathing Audiovisual Intervention on Psychosocial Functioning in Palestinian Adolescents

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 25, 2025
Registry last updated
Oct 14, 2025

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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