About this trial
This randomized controlled trial aims to evaluate the efficacy of a universal intervention based on Natural Psychotherapy in reducing anxiety and depressive symptoms among primary and middle school students. To evaluate both the clinical outcomes and the potential underlying mechanisms of change, data will be collected at four distinct time points: baseline (pre-intervention), post-intervention, 3-month follow-up, and 6-month follow-up.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages: 7 to 18 years.
Population: School-aged children and adolescents currently enrolled and attending primary or secondary school.
Capacity: Ability to comprehend the study procedures and provide assent (or consent, if applicable).
Disqualifiers
School Attendance: Children not currently attending school or on long-term academic leave.
General Exclusion: Any condition that, in the opinion of the investigator or school physician, would interfere with the participant's ability to attend school or comply with study procedures.
Trial design
Parallel
Treatments tested in this trial
Multi-modal Nature-based Meditation
BehavioralA 4-week universal group meditation practice delivered in classrooms. The intervention aims to reduce anxiety and depressive symptoms through nature-based mindfulness exercises.
Intervention diary
BehavioralParticipants are required to maintain a daily log of their meditation practice and life events, with a particular focus on instances of emotional fluctuation and their corresponding behavioral responses.
Treatment groups
Trial outcomes
Primary outcomes
Generalized Anxiety Disorder-7 Scale (GAD-7)
A 7-item self-report scale assessing the severity of anxiety symptoms over the past two weeks. Scores range from 0 to 21, with higher scores indicating more severe anxiety. Clinical cut-off scores are: 0-4 (minimal/no clinical anxiety), 5-9 (mild), 10-14 (moderate),and≥ 15 (severe). This is a widely used, valid, and reliable tool for screening and monitoring anxiety in adolescents. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Ruminative Responses Scale (RRS)
Symptom Rumination: Assesses repetitive focus on the symptoms of distress (e.g., feelings of sadness, fatigue, and loneliness). Brooding: Assesses a moody, reflective style characterized by passive comparison of one's current situation with unachieved standards. Reflective Pondering: Assesses purposeful and reflective examination of one's mood and its causes to gain insight. Scoring: Each item is rated on a 4-point Likert scale from 1 (almost never) to 4 (almost always). Total scores range from 22 to 88. Higher total scores indicate a greater tendency toward rumination. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Secondary outcomes
Mindfulness - Mindful Attention Awareness Scale (MAAS)
A 15-item self-report scale measuring dispositional mindfulness.Each item is rated on a 6-point Likert scale from 1 (almost always) to 6 (almost never). Scoring is computed as the mean of all 15 items, with scores ranging from 1 to 6.Higher scores indicate greater levels of dispositional mindfulness (Brown \& Ryan, 2003).Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Perceived Stress - Perceived Stress Scale (PSS-10)
A 10-item self-report questionnaire measuring perceived stress over the past month.Each item is rated on a 5-point Likert scale from 0 (never) to 4 (very often). Four positively worded items are reverse-scored. Total scores range from 0 to 40, with higher scores indicating greater perceived stress. Interpretive guidelines: 0-13 (low), 14-26 (moderate), 27-40 (high stress) (Cohen et al.,1983). Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Resilience - Connor - Davidson Resilience Scale (CD-RISC-10)
A 10-item self-report scale measuring resilience. Each item is rated on a 5-point Likert scale from 0 (not true at all) to 4 (true nearly all the time). Total scores range from 0 to 40, with higher scores indicating greater resilience (Campbell-Sills \& Stein, 2007). Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Insomnia Severity - Insomnia Severity Index (ISI)
A 7-item self-report questionnaire assessing insomnia severity over the past two weeks. Each item is rated on a 5-point Likert scale from 0 (no problem) to 4 (very severe problem). Total scores range from 0 to 28,with higher scores indicating more severe insomnia. Cutoffs: 0-7 (no clinically significant insomnia), 8-14 (subthreshold), 15-21 (moderate), 22-28 (severe) (Bastien et al.,2001). Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month
Other outcomes
Positive and Negative Rumination Scale (PANRS)
The aim was to separately explore the positive and negative aspects of rumination. The scale consists of 23 items and is divided into five factors: enjoying happiness, suppressing happiness, negative attribution, positive coping, and self-denial. The PANRS uses a 4-point Likert scale from 1 (almost never) to 4 (almost always). A higher score indicates a more severe tendency towards rumination. In this study, only the factors of enjoying happiness and positive coping were used. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Executive Function -Self-report Executive Function Scale
Assesses key aspects of executive function such as cognitive flexibility, working memory, and inhibitory control in daily functioning. In this study, only the cognitive flexibility and working memory dimensions from the scale were used. Each item is rated on a 3-point Likert scale from 1 (never) to 3 (often). After reverse scoring, total scores range from 15-45, with higher scores indicating better executive functioning. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Internet Gaming Disorder Risk - Brief Internet Gaming Disorder Scale (IGDS9-SF)
A 9-item self-report scale screening for symptoms of problematic gaming behavior based on DSM-5 criteria. Each item is rated on a 5-point Likert scale from 1 (never) to 5 (very often). Total scores range from 9 to 45, with higher scores indicating greater risk of internet gaming disorder. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Non-Suicidal Self-Injury - Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ)
The ANSAQ is a questionnaire assessing frequency, methods, and functions of Non-Suicidal Self-Injury (NSSI) behaviors in adolescents. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (always). This study utilized 12 items from the behavioral questionnaire. Total scores range from 0 to 48, with higher scores indicating more diverse methods or higher frequency of non-suicidal self-injury over the past year. Includes follow-up questions on context and triggers. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Sponsors and contacts
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Beijing HuiLongGuan Hospital
Lead sponsor
Tsinghua University
Sponsor institution
Capital Normal University
Collaborator
Tsinghua University
Collaborator
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