Clinical Efficacy and Change of Life Quality Through Using the Comprehensive Behavioral Intervention Treatment for Tics

Tic Disorders Clinical Trial

Official title:

Study on the Clinical Efficacy and Change of Life Quality Through Using the Comprehensive Behavioral Intervention Treatment for Tics (CBIT)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04765085
• Other study ID #: Sunjinhua
• Status: Withdrawn
• Phase: N/A
• Start date: March 2021
• Est. completion date: September 2022

Study information

• Verified date: February 2021
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study on the clinical efficacy and change of life quality through using the Comprehensive Behavioral Intervention Treatment for Tics (CBIT)

Description:

This study tried to explore the clinical effect of comprehensive behavioral intervention therapy (CBIT) on tic symptoms and the effect of improving the quality of life in children with tic disorders;explore the optimal treatment plan for tic disorder by comparing the clinical efficacy of CBIT therapy, drug therapy, and psychosocial education; explore the feasibility of using quality of life as an evaluation index for functional recovery after tic disorder treatment;

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

Inclusion Criteria:

• Meets the diagnostic criteria for chronic tic disorder or Tourette syndrome (TS) according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), and has been diagnosed by two pediatric psychiatrists who are associate chief physicians or more;
• The age ranged from 9 to 16 years old;
• The total score of tic symptoms in the Yale global Tic Severity Scale (YGTSS) is 13-30;
• Childrens Webster's Intelligence Scale = 85
• Co-morbid ADHD, but the drug treatment dose for ADHD is stable (the drug has been stabilized for more than 6 weeks), or no drug has been taken at the beginning and during the stud

Exclusion Criteria:

• There are brain organic diseases, metabolic diseases, psychiatric disorders, drug-induced involuntary movement and other extrapyramidal lesions;
• Habit reversal training and other behavioral treatments for more than 4 weeks;
• unwilling participants or disobedient subgroups in the study

Related Conditions & MeSH terms

• Tic Disorders

Intervention

Behavioral:
• comprehensive behavioral intervention therapy (CBIT)
Comprehensive behavioral intervention for tics is an extension of habit reversal training. It includes an expanded set of strategies, such as psycho-education about tic disorders, tic awareness training, competing response training, relaxation training, and functional analysis. According to the CBIT treatment manual (translated by sun Jinhua and Xu Wen, the author were Douglas W. woods et al., Oxford University Press, New York). The treatments consisted of 8 sessions for 10 weeks The first two phases were 1.5 hours, the last six stages were 1 hour.The treatment process was regularly supervised by a treatment supervisor.

Drug:
• Aripiprazole 5Mg Oral Tablet
Considering the patients with chronic tic disorder (chronic motor or vocal tic disorder or Tourette's disorder), aripiprazole was selected as a single drug with constant dose during the treatment. In case of extrapyramidal side effects, benhexol was given to reduce the extrapyramidal side effects, and the dosage and duration of medication were recorded

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction rate of Tic symptom severity before and after intervention	Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening.; Reduction rate = (YGTSS total score before intervention - YGTSS total score after intervention) / YGTSS total score before treatment × 100%	Baseline, the tenth week of treatment
Secondary	overall treatment response	The overall treatment response is measured by CG-I. This is a repeated measurement variable.The CGI-I was used to measure overall treatment response. The scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). We defined positive response as a score of 1 or 2 (much improved or very much improved).	The fifth week and the tenth week of treatment and three month after treatment end
Secondary	life quality	Pediatric Quality of Life Inventory (PedsQL) and Child Tourette's Syndrome Impairment Scale(CTIM) were used to assessed health-related QoL.This is a repeated measurement variable.; PedsQL was a widely used 15-item measure assessed health-related QoL. Parents were asked to rate how often a particular item had been a problem during the past month using a 5-point Likert scale ranging from ''never a problem'' to ''almost always a problem." Total scores were linearly transformed to a scale of 0 to 100. Higher scores indicated better QoL. Four subscales measured physical, emotional, social, and school functioning.; The CTIM-P is a 37-item parent-rated instrument that includes school, home, and social activities that may be impaired by their child's tics or a co-morbid problem (e.g., obsessive-compulsive symptoms, depressed mood, anxiety, oppositional/disruptive behavior, hyperactivity, inattentiveness).	The fifth week and the tenth week of treatment and three month after treatment end