Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo — DCS+HRT  

Chronic Tic Disorder Clinical Trial

Official title: Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo

Status Completed

Clinical Trial Summary

Expert reviews and practice parameter papers recommend behavior therapy as a first-line intervention for youth with chronic tic disorders (CTDs) with mild-to-moderate tic severity. Although behavior therapies like the Comprehensive Behavioral Intervention for Tics (CBIT) are efficacious in reducing tic symptom severity, only 50% of individuals exhibit a positive treatment response. Thus, there is a clear need to identify strategies to improve treatment response and/or accelerate therapeutic gains .

The primary ingredient of CBIT is habit reversal training (HRT), which utilizes both extinction and associative learning. Psychosocial treatments relying on these learning mechanisms have demonstrated an enhanced and/or expedited therapeutic benefit when augmented with d-cycloserine (DCS). This feasibility study will examine the incremental efficacy of HRT+DCS over HRT+placebo for tics targeted with HRT. Eligibility criteria will parallel the child CBIT trial for generalizability and comparability, with the addition of DCS contraindications as exclusionary criteria. Parents and youth will complete a battery of clinical assessments to ascertain tic symptoms severity and co-occurring psychiatric conditions. Afterwards, participants will be randomly assigned to receive either HRT+DCS or HRT+placebo. Instead of a full course of HRT (8 sessions over 10 weeks), a more efficient Quick-Win/Fast-Fail trial design will be used that includes a truncated HRT protocol to provide results in a more timely fashion. As a result of this trial design, the primary outcome of this study will focus on the reduction of bothersome tic severity for those targeted in treatment rather than global severity reductions.

Clinical Trial Description

Expert reviews and practice parameter papers recommend behavior therapy as a first-line intervention for youth with chronic tic disorders (CTDs) with mild-to-moderate tic severity. Although behavior therapies like the Comprehensive Behavioral Intervention for Tics (CBIT) are efficacious in reducing tic symptom severity, only 50% of individuals exhibit a positive treatment response. Thus, there is a clear need to identify strategies to improve treatment response and/or accelerate therapeutic gains. The primary ingredient of CBIT is habit reversal training (HRT), which utilizes both extinction and associative learning. Psychosocial treatments relying on these learning mechanisms have demonstrated an enhanced and/or expedited therapeutic benefit when augmented with d-cycloserine (DCS). This feasibility study will examine the incremental efficacy of HRT+DCS over HRT+placebo for tics targeted with HRT. Eligibility criteria will parallel the child CBIT trial for generalizability and comparability, with the addition of DCS contraindications as exclusionary criteria. Parents and youth will complete a battery of clinical assessments to ascertain tic symptoms severity and co-occurring psychiatric conditions. Afterwards, participants will be randomly assigned to receive either HRT+DCS or HRT+placebo. Instead of a full course of HRT (8 sessions over 10 weeks), a more efficient Quick-Win/Fast-Fail trial design will be used that includes a truncated HRT protocol to provide results in a more timely fashion. As a result of this trial design, the primary outcome of this study will focus on the reduction of bothersome tic severity for those targeted in treatment rather than global severity reductions. ;

Related Conditions & MeSH terms

• Chronic Tic Disorder
• Disease
• Tic Disorders
• Tics
• Tourette Disorder
• Tourette Syndrome

• NCT number: NCT02582515
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Completion date: August 2017