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

NCT04765085 | Withdrawn

• 1 other identifier: Sunjinhua
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Tic Disorders

Keywords

comprehensive behavioral intervention therapy; drug therapy; Psychosocial education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• overall treatment response

  The fifth week and the tenth week of treatment and three month after treatment end

• life quality

  The fifth week and the tenth week of treatment and three month after treatment end

Study Arms (2)

CBIT Group

EXPERIMENTAL

Patients in this group would only receive the CBIT treatment.

Behavioral: comprehensive behavioral intervention therapy (CBIT)

Drug therapy Group

EXPERIMENTAL

Patients in this group would only receive the drug therapy.

Drug: Aripiprazole 5Mg Oral Tablet

Interventions

comprehensive behavioral intervention therapy (CBIT) BEHAVIORAL

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.

CBIT Group

Aripiprazole 5Mg Oral Tablet DRUG

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

Drug therapy Group

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

MeSH Terms

Conditions

Tic Disorders

Interventions

Aripiprazole; Tablets

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: February 21, 2021
• Study Start: March 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02