Online Medical Hypnosis Exercises to Improve Mental Health in Primary School Children and Prevent Future Mental Health Issues

Обзор

The goal of this trial is to learn if listening daily to online hypnosis exercises helps to improve mental health and self-esteem in primary school children. In the future we also hope to see if it can prevent feelings of depession or anxiety when these children have become teenagers. The main questions it aims to answer are: 1. can daily listening to these exercsies improve self-esteem, resilience and mental health of children 10-11 years compared to children who do not listen to these exercises? 2. can listening to these exercsies prevent future metal health problems like feelings of depression or anxiety. Researchers will compare a group of children (10-11 years) who will listen daily to the exercises for 2 months with a group who will do that 6 months later. Participants will: Listen daily to a hypnosis exercise of maximum 15 minutes. Fill out questionnaires on self-esteem, resilience and mental health before during and after the study.

Подробное описание

SUMMARY

Rationale:

Early adolescence marks a crucial period for the development and onset of mental health problems, which often manifest as disorders in the course of adulthood if they are not dealt with early on. Moreover, there is an increased prevalence of disorders like anxiety and depression in adolescence. Prevention of these mental health problems is of great importance.

Objective: The primary objective is to study the effect of daily listening for 6 weeks to the Breinbaas hypnosis recordings on selfesteem compared to controls. Secondary objective(s) are studying the effect of daily listening to the Breinbaas hypnosis recordings for 6 weeks on change in resilience, psychosocial functioning, overall stress level, and other effects like sleep compared to controls. Study design: This is a randomized controlled open-label study with a duration of six months. Children will be randomized to start immediately with the online program (Group A) or after 6 months (group B). Group B will therefore be the control group of A.

Study population: Children from grade 6 or 7 of the participating primary schools will be invited to participate. Schools will be recruited in 3 areas in the Netherlands.

Intervention: The online Breinbaas academy program consists of hypnosis audio recordings that children will listen to on every schoolday for six weeks. The hypnosis audio recordings aim to improve children's mental health.

Main study parameters/endpoints: Children fill out questionnaires at baseline, 6 weeks and 6 months about the child's self-esteem, psychosocial functioning, resilience, stress levels, and sleep.

Вмешательства

• Поведенческое standardized audio hypnosis recordings for healthy children at primary school
  8 different audio hypnosis recordings hat chidlren will listen too at a daily basis (one recording per day)

Первичные конечные точки

• Difference in change in self-esteem between group A and B. [Срок оценки: difference between baseline and the end of listening to the exercises at 6 weeks.]

Вторичные конечные точки (3)

• Improvement in resilience on short and long term. [Срок оценки: CD-RISC will measured between baseline and six weeks and between baseline and after 6 months.]
• Improvement in psychosocial functioning on short and long term.. [Срок оценки: The difference in SDQ will be measured between baseline and six weeks, and between baseline and after 6 months.]
• Stress reduction at short and long term. [Срок оценки: The CSQ-CA will be measured at baseline, 6 weeks, and 6 months in both groups.]

Критерии участия

Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Fluent in Dutch
• Attending group 6 or 7 of a regular primary school in the Netherlands
• Permission of the parents to listen daily to one of the Breinbaas hypnosis exercises (maximum 20 minutes per day)
• Access to an electronic device to listen to the Breinbaas exercises (phone, tablet, computer) -

Критерии исключения

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Children treated with hypnotherapy in the three years preceding potential inclusion
• Children currently receiving psychological treatment

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

Простое слепое

Основная цель

Профилактика

Центры проведения

Нидерланды · 1 центр

• University Leiden — Leiden

Публикации

• Rutten JMTM, Vlieger AM, Frankenhuis C, George EK, Groeneweg M, Norbruis OF, Tjon A Ten W, van Wering HM, Dijkgraaf MGW, Merkus MP, Benninga MA. Home-Based Hypnotherapy Self-exercises vs Individual Hypnotherapy With a Therapist for Treatment of Pediatric Irritable Bowel Syndrome, Functional Abdominal Pain, or Functional Abdominal Pain Syndrome: A Randomized Clinical Trial. JAMA Pediatr. 2017 May 1 PMID 28346581

Идентификаторы

NCT: NCT07157358 · NL 87558.100.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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