Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo
Condition: Tourette Disorder; Chronic Tic Disorder
MeSH terms: Tic Disorders; Tourette Syndrome
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): D-cycloserine; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Habit Reversal Training; Habit Reversal Training
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: d-cycloserine; comprehensive behavioral intervention for tics; habit reversal training