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

Muvik Labs

Status: Completed

Conditions: Depression Not Otherwise Specified; Anxiety; Self-Efficacy

Treatments: Device: Mindfulness video sessions; Device: Paced breathing wellness breathing sessions

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06988800

MECI_Adolescent

Details and patient eligibility

About

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.

Full 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.

Enrollment: 213 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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213 participants in 3 patient groups

Guided Paced Breathing Audiovisual Intervention

Experimental group

Description:

Paced Breathing intervention delivered

Treatment:

Device: Paced breathing wellness breathing sessions

Guided Mindfulness Audiovisual Intervention

Experimental group

Description:

Mindfulness intervention delivered

Treatment:

Device: Mindfulness video sessions

Control

No Intervention group

Description:

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.