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

A Randomized Controlled Trial of Online Cognitive Behavioral Therapy for Children with Emotional and Behavioral Problems.

Shimizu Eiji

Chiba University School of Medicine

1-8-1 Inohana Chuo-ku Chiba city Chiba

eiji@faculty.chiba-u.jp

Mie Matsutomo

Chiba Universiy

1-8-1 Inohana Chuo-ku Chiba city Chiba

+81-43-226-2975

mie-matsutomo@chiba-u.jp

Recruiting

Mar. 29, 2024

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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.
1) 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.
2) 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.
3) Persons who are between the ages of 12 (junior high school) and 18 at the time of obtaining consent.
4) 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.
5) Who are mentally and physically capable of understanding and practicing cognitive behavioral therapy for at least two months on a sustained basis.
6) Who have the ability and environment to use the Internet and computer to receive online cognitive behavioral therapy using a video conferencing system.
7) 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.

Persons who meet any of the following conditions are not eligible.
1) 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.
2) Those who are distressed by ongoing stressful events.
3) Those who have difficulty in contacting the researcher.
4) 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.
5) For those undergoing MRI, those who may be adversely affected physically or mentally by the MRI examination (tattoos, pacemakers, claustrophobia, possible pregnancy, etc.)

Both

emotional and behavioral symptoms

As a psychological intervention using a videoconferencing system, the therapist will conduct weekly 60-minute online cognitive-behavioral therapy sessions once a week for a total of six sessions, using a manual we developed on "Imagery Rescripting".

emotional and behavioral symptoms

cognitive behavioral therapy

D000066553

D015928

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

The change of score in the following assessment items at Week 7 (post evaluation) from Week 0 (baseline).
1) SDQ subscale (self-administered)
2) Impact of Event Scale-Revised (IES-R) (self-administered)
3) Depression assessment using the Patient Health Questionnaire-9 modified for adolescents (PHQ-A) (self-administered)
4) Anxiety state assessment using the Generalized Anxiety Disorder-7 (GAD-7) (self-administered by the patient)
5) Quality of life assessment using the Euro QOL 5 Dimensions, Youth version (EQ-5D-Y) (self-administered)
6) Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RC9) for children (self-administered)
7) Fear of Compassion Scale (self-administered)
8) Client Satisfaction Questionnaire (CSQ-8J) (self-administered)
9) TDS, subscale, and Impact Score of the SDQ-P (parent or mother or father, self-administered)

+81-43-226-2616

Feb. 22, 2024

Yes

In order to clarify disease-specific abnormalities in brain morphology and function, the data obtained in this study may be used in the following research (Research Section Title: "Exploratory Study of the Effects of Cognitive Behavioral Therapy and MRI Brain Image Changes," Approval Number M10545). Other information obtained may be used for future research that is not identified at the time consent is received, or may be provided to other research institutions. When using the information for other purposes, after it is again applied for and approved by the Ethics Committee in accordance with laws and regulations, it will be disclosed on the medical institution's website, and appropriate consent will be obtained, such as by providing an opportunity to refuse participation in the research (opt-out).

none