AnxietyNCT06988800
Musically-Guided Paced Breathing Improves Mental Health in War-Affected Adolescents
A study testing Paced breathing wellness breathing sessions and Mindfulness video sessions in people with Anxiety and Self-Efficacy, run by Muvik Labs at 1 site in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Self-Efficacy, Depression Not Otherwise Specified
- What is being tested?
- Paced breathing wellness breathing sessions and Mindfulness video sessions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 21 Jan 2024to 9 May 2024
- Phase
- Interventional
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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participating in MECI after school program and between the ages of 13 and 17.
Who cannot join
- Not participating in MECI after school program or outside of the ages of 13 and 17.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Examining the Impact of a Guided Paced Breathing Audiovisual Intervention on Psychosocial Functioning in Palestinian 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.
Read the detailed description
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.
- Conditions
- Anxiety, Self-Efficacy, Depression Not Otherwise Specified
- Being tested
- Paced breathing wellness breathing sessions, Mindfulness video sessions
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paced breathing wellness breathing sessionsDevice
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 sessionsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided Paced Breathing Audiovisual Intervention | Experimental | Paced Breathing intervention delivered Receives: Device: Paced breathing wellness breathing sessions |
| Guided Mindfulness Audiovisual Intervention | Experimental | Mindfulness intervention delivered Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start21 Jan 2024
- Primary completion9 May 2024
- Study completion9 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muvik Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MECI
- Responsible party
- Sponsor
- Investigators
- Chelsea Gordon, PhD, Study director, Muvik Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988800
- Sponsor's protocol ID
- MECI_Adolescent
- Status last verified
- Sep 2025
- First submitted
- 16 May 2025
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28878812