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

NCT06988800 | Completed Results

• 1 other identifier: MECI_Adolescent
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Self-Efficacy; Depression Not Otherwise Specified

Outcome Measures

Primary Outcomes (3)

• Revised Children's Manifest Anxiety Scale (RCMAS)

  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.

  From enrollment to the end of treatment at 12 weeks

• Self-Efficacy Questionnaire for Children (SEQ-C)

  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.

  From enrollment to the end of treatment at 12 weeks

• Patient Health Questionnaire 9 (PHQ-9)

  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.

  From enrollment to the end of treatment at 12 weeks

Study Arms (3)

Guided Paced Breathing Audiovisual Intervention

EXPERIMENTAL

Paced Breathing intervention delivered

Device: Paced breathing wellness breathing sessions

Guided Mindfulness Audiovisual Intervention

EXPERIMENTAL

Mindfulness intervention delivered

Device: Mindfulness video sessions

Control

NO INTERVENTION

Participants in the control condition completed other typical after-school activities while participants in the intervention condition completed one of two breathing interventions: paced breathing (paced), or mindful breathing (mindfulness). Participants in the control condition were given the opportunity to complete the intervention after the study ended.

Interventions

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.

Guided Paced Breathing Audiovisual Intervention

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.

Guided Mindfulness Audiovisual Intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Muvik Labs: lead
• MECI: collaborator

Study Sites (1)

MECI

Deir Ghassaneh, West Bank, Palestinian Territories

Location

Related Publications (1)

• AlHadi AN, AlAteeq DA, Al-Sharif E, Bawazeer HM, Alanazi H, AlShomrani AT, Shuqdar RM, AlOwaybil R. An arabic translation, reliability, and validation of Patient Health Questionnaire in a Saudi sample. Ann Gen Psychiatry. 2017 Sep 6;16:32. doi: 10.1186/s12991-017-0155-1. eCollection 2017.

  PMID: 28878812 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr. Chelsea Gordon
• Organization: Muvik

chelsea@muviklabs.io

9063990332

Study Officials

• Chelsea Gordon, PhD

  Muvik Labs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: January 21, 2024
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2024
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)