Anxiety, Depression Not Otherwise Specified, Self-Efficacy
Conditions
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.
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.
Interventions
DEVICEPaced breathing wellness breathing sessions
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.
DEVICEMindfulness video sessions
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.
Sponsors
MECI
Muvik Labs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revised Children's Manifest Anxiety Scale (RCMAS) | 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. |
| Self-Efficacy Questionnaire for Children (SEQ-C) | 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. |
| Patient Health Questionnaire 9 (PHQ-9) | 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. |
Countries
Palestinian Territories
Participant flow
Recruitment details
Students were included in this study if they were children aged 13-17 years and enrolled in January 2024 at a school in a war-torn area in the West Bank in the Middle East.
Participants by arm
| Arm | Count |
|---|---|
| Guided Paced Breathing Audiovisual Intervention Paced Breathing intervention delivered
Paced breathing wellness breathing sessions: 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. | 64 |
| Guided Mindfulness Audiovisual Intervention Mindfulness intervention delivered
Mindfulness video sessions: 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. | 77 |
| Control 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. | 72 |
| Total | 213 |
Baseline characteristics
| Characteristic | Guided Paced Breathing Audiovisual Intervention | Guided Mindfulness Audiovisual Intervention | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 13.81 years STANDARD_DEVIATION 0.99 | 13 years STANDARD_DEVIATION 1.1 | 14.45 years STANDARD_DEVIATION 0.97 | 13.75 years STANDARD_DEVIATION 1.19 |
| Patient Health Questionnaire-9 | 10.62 units on a scale STANDARD_DEVIATION 5.64 | 9.44 units on a scale STANDARD_DEVIATION 6.57 | 10.09 units on a scale STANDARD_DEVIATION 6.59 | 10.03 units on a scale STANDARD_DEVIATION 6.29 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Palestine | 64 participants | 77 participants | 72 participants | 213 participants |
| Revised Children's Manifest Anxiety Scale | 17.61 units on a scale STANDARD_DEVIATION 8.13 | 18.67 units on a scale STANDARD_DEVIATION 8.73 | 17.64 units on a scale STANDARD_DEVIATION 8.39 | 18 units on a scale STANDARD_DEVIATION 8.41 |
| Self-Efficacy Questionnaire for Children | 56.67 units on a scale STANDARD_DEVIATION 15.92 | 53.76 units on a scale STANDARD_DEVIATION 19.4 | 54.9 units on a scale STANDARD_DEVIATION 17.29 | 55.05 units on a scale STANDARD_DEVIATION 17.64 |
| Sex: Female, Male Female | 36 Participants | 38 Participants | 38 Participants | 112 Participants |
| Sex: Female, Male Male | 28 Participants | 39 Participants | 34 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 77 | 0 / 72 |
| other Total, other adverse events | 0 / 64 | 0 / 77 | 0 / 72 |
| serious Total, serious adverse events | 0 / 64 | 0 / 77 | 0 / 72 |
Outcome results
Primary
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.
Time frame: From enrollment to the end of treatment at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guided Paced Breathing Audiovisual Intervention | Patient Health Questionnaire 9 (PHQ-9) | 5.82 units on a scale | Standard Deviation 5.04 |
| Guided Mindfulness Audiovisual Intervention | Patient Health Questionnaire 9 (PHQ-9) | 5.86 units on a scale | Standard Deviation 5.71 |
| Control | Patient Health Questionnaire 9 (PHQ-9) | 10.83 units on a scale | Standard Deviation 6.93 |
Comparison: ANCOVAs and post hoc Tukey pairwise testsp-value: <0.001ANCOVA
Primary
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.
Time frame: From enrollment to the end of treatment at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guided Paced Breathing Audiovisual Intervention | Revised Children's Manifest Anxiety Scale (RCMAS) | 24.88 units on a scale | Standard Deviation 6.61 |
| Guided Mindfulness Audiovisual Intervention | Revised Children's Manifest Anxiety Scale (RCMAS) | 26.2 units on a scale | Standard Deviation 5.82 |
| Control | Revised Children's Manifest Anxiety Scale (RCMAS) | 17.91 units on a scale | Standard Deviation 8.28 |
Comparison: ANCOVAs and post hoc Tukey pairwise testsp-value: <0.001ANCOVA
Primary
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.
Time frame: From enrollment to the end of treatment at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guided Paced Breathing Audiovisual Intervention | Self-Efficacy Questionnaire for Children (SEQ-C) | 64.81 units on a scale | Standard Deviation 16.15 |
| Guided Mindfulness Audiovisual Intervention | Self-Efficacy Questionnaire for Children (SEQ-C) | 64.65 units on a scale | Standard Deviation 14.97 |
| Control | Self-Efficacy Questionnaire for Children (SEQ-C) | 49.7 units on a scale | Standard Deviation 20.29 |
Comparison: ANCOVAs and post hoc Tukey pairwise tests.p-value: <0.001ANCOVA