Study on Mental Health Promoting Effects of Natural Psychotherapy for Adolescents

Официальное название

The Effect of Universal Intervention Based on Natural Psychotherapy: Evidence From Chinese Adolescents

Обзор

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.

Подробное описание

Objective 1: Evaluate the Efficacy of Natural Psychotherapy on Primary Outcomes (Anxiety Symptoms and Rumination) To evaluate the short-term and sustained efficacy of the Natural Psychotherapy program in reducing anxiety symptoms and maladaptive rumination among primary and middle school students compared to standard schooling.

Objective 2: Assess the Impact on Secondary Outcomes (Psychological Well-being, Emotional Regulation, Stress, Sleep, Self-Esteem, Depression, Life Satisfaction, and Social Support) To assess the effects of the Natural Psychotherapy program on secondary psychological outcomes, including mindfulness, perceived stress, resilience, insomnia severity, self-esteem, depressive symptoms, life satisfaction, eudaimonic well-being, and perceived social support, and to examine whether improvements in these domains mediate the primary outcomes.

Objective 3: Explore the Mechanisms of Change and Predictors of Treatment Response To explore the underlying psychological mechanisms through which Natural Psychotherapy produces its therapeutic effects on primary outcomes (anxiety and rumination) and to identify baseline predictors and moderators of treatment response.

Вмешательства

• Поведенческое Multi-modal Nature-based Meditation
  A 4-week universal group meditation practice delivered in classrooms. The intervention aims to reduce anxiety and depressive symptoms through nature-based mindfulness exercises.
• Поведенческое Intervention diary
  Participants 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.

Первичные конечные точки

• Generalized Anxiety Disorder-7 Scale (GAD-7) [Срок оценки: Week 1, Week 5, Week 9, Week 17, Week 29]
• Ruminative Responses Scale (RRS) [Срок оценки: Week 1, Week 5, Week 9, Week 17, Week 29]

Вторичные конечные точки (9)

• Mindfulness - Mindful Attention Awareness Scale (MAAS) [Срок оценки: Week 1, Week 5, Week 9, Week 17, Week 29]
• Perceived Stress - Perceived Stress Scale (PSS-10) [Срок оценки: Week 1, Week 5, Week 9, Week 17, Week 29]
• Resilience - Connor - Davidson Resilience Scale (CD-RISC-10) [Срок оценки: Week 1, Week 5, Week 9, Week 17, Week 29]
• Insomnia Severity - Insomnia Severity Index (ISI) [Срок оценки: Week 1, Week 5, Week 9, Week 17, Week 29]
• Self-Esteem -Rosenberg Self-Esteem Scale (SES) [Срок оценки: Week 1, Week 5, Week 9, Week 17, Week 29]
• The Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Week 1, Week 5, Week 9, Week 17, Week 29]
• Life Satisfaction [Срок оценки: Week 1, Week 5, Week 9, Week 17, Week 29]
• Perceived Social Support - Multidimensional Scale of Perceived Social Support (MSPSS) [Срок оценки: Week 1, Week 5, Week 9, Week 17, Week 29]
• Eudaimonic Well-being - Flourishing Scale (FS-8) [Срок оценки: Week 1, Week 5, Week 9, Week 17, Week 29]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Capital Normal University, Beijing — Пекин

Публикации

• Koivisto, M. , & Grassini, S. . (2022). Mental imagery of nature induces positive psychological effects. Current Psychology, 1-16.
• Chen YQ, Li XR, Zhang L, Zhu WB, Wu YQ, Guan XN, Xiu MH, Zhang XY. Therapeutic Response Is Associated With Antipsychotic-Induced Weight Gain in Drug-Naive First-Episode Patients With Schizophrenia: An 8-Week Prospective Study. J Clin Psychiatry. 2021 May 11;82(3):20m13469. doi: 10.4088/JCP.20m13469. PMID 34004092
• Wang DM, Chen DC, Xiu MH, Wang L, Kosten TR, Zhang XY. A double-blind, randomized controlled study of the effects of celecoxib on clinical symptoms and cognitive impairment in patients with drug-naive first episode schizophrenia: pharmacogenetic impact of cyclooxygenase-2 functional polymorphisms. Neuropsychopharmacology. 2024 Apr;49(5):893-902. doi: 10.1038/s41386-023-01760-8. Epub 2023 Oct 30. PMID 37903861

Идентификаторы

NCT: NCT07639476 · CNU-202601001 · CNU-202601001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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