跳至主要内容
临床试验/jRCT1032230758
jRCT1032230758招募中不适用

A Randomized, Wait-List Controlled Trial of Online Cognitive Behavioral Therapy Using Imagery Rescripting for Children with Emotional and Behavioral Problems.

Cognitive Behavioral Therapy Center, Chiba University Hospital0 个研究点目标入组 26 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
26
主要终点
The change in the Total Difficulties Score (TDS) of the Strengths and Difficulties Questionnaire (SDQ)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
12age old over 至 18age old under(—)
性别
All

入选标准

  • Patients who meet all of the following conditions 1)-7) will be included in the study. In addition, the patient's custodian or mother or father will participate in this study by answering the questionnaire as a guardian.
  • Those who are currently experiencing emotional or behavioral symptoms, episodes of distress or disability, and is troubled by recurring memories of the past. The primary diagnoses are trauma- and stressor-related disorders excluding post-traumatic stress disorder (acute stress disorder, adjustment disorder, adjustment-like disorder, unspecified stressor-related disorder, etc.), depressive disorders (major depressive disorder, persistent depressive disorder, etc.), anxiety disorders (generalized anxiety disorder, social anxiety disorder, specific phobia, panic disorder, agoraphobia, selective mutism, etc.), bipolar II disorder, obsessive-compulsive and related disorders (obsessive-compulsive disorder, body dysmorphic disorder, hoarding disorder, trichotillomania, excoriation disorder, etc.), disruptive,impulse-control, and Conduct Disorders (oppositional defiant disorder, intermittent explosive disorder, Conduct disorder, etc.), dissociative disorders (dissociative identity disorder, dissociative amnesia, depersonalization/derealization disorder, etc.), somatic symptom and related disorders (somatic symptom disorder, conversion disorder, etc.), and personality disorders.
  • Those with a TDS (Total Difficulties Score) of 16 or more points on the SDQ (Strength and Difficulties Questionnaire) and who wish to receive relief through online cognitive behavioral therapy.
  • Persons who are between the ages of 12 (junior high school) and 18 at the time of obtaining consent.
  • The individual has been fully informed of the study and has obtained the free written consent of the individual and his/her surrogate (person with parental authority or father or mother) after full understanding of the study.
  • Who are mentally and physically capable of understanding and practicing cognitive behavioral therapy for at least two months on a sustained basis.
  • Who have the ability and environment to use the Internet and computer to receive online cognitive behavioral therapy using a video conferencing system.
  • Who can make a referral from a family physician such as a pediatrician, internist, psychosomatic medicine, psychiatrist, or child psychiatrist, with or without medication, but no new medications are planned to be added or changed during the study period.

排除标准

  • Persons who meet any of the following conditions are not eligible.
  • Those with post-traumatic stress disorder, severe autism spectrum disorder, severe attention deficit hyperactivity disorder, intellectual disability, organic mental disorder, psychosis including schizophrenia, bipolar I disorder, eating disorders, substance-related and addictive disorders, or imminent risk of suicide.
  • Those who are distressed by ongoing stressful events.
  • Those who have difficulty in contacting the researcher.
  • Any other person who is deemed inappropriate for the safe conduct of this study by the study investigator or the psychologist in charge of the study.
  • For those undergoing MRI, those who may be adversely affected physically or mentally by the MRI examination (tattoos, pacemakers, claustrophobia, possible pregnancy, etc.)

结局指标

主要结局

The change in the Total Difficulties Score (TDS) of the Strengths and Difficulties Questionnaire (SDQ)

时间窗: Week 0 (baseline) to Week 7 (post evaluation)

The change in the Total Difficulties Score (TDS) of the Strengths and Difficulties Questionnaire (SDQ) at Week 7 (post evaluation) from Week 0 (baseline).

次要结局

  • SDQ subscale(Week 7 (post evaluation) from Week 0 (baseline))
  • Impact of Event Scale-Revised (IES-R)(Week 7 (post evaluation) from Week 0 (baseline))
  • Patient Health Questionnaire-9 modified for adolescents (PHQ-A)(Week 7 (post evaluation) from Week 0 (baseline))
  • Generalized Anxiety Disorder-7 (GAD-7)(Week 7 (post evaluation) from Week 0 (baseline))
  • Euro QOL 5 Dimensions, Youth version (EQ-5D-Y)(Week 7 (post evaluation) from Week 0 (baseline))
  • Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RC9)(Week 7 (post evaluation) from Week 0 (baseline))
  • Fear of Compassion Scale(Week 7 (post evaluation) from Week 0 (baseline))
  • Client Satisfaction Questionnaire (CSQ-8J)(Week 7 (post evaluation) from Week 0 (baseline))
  • TDS, subscale, and Impact Score of the SDQ-P(Week 7 (post evaluation) from Week 0 (baseline))

研究者

发起方
Cognitive Behavioral Therapy Center, Chiba University Hospital

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