- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07725926
INTEGRATING EXPOSURE AND RESPONSE PREVENTION AND HABIT REVERSAL TECHNIQUES TO TREAT A TOURETTIC SUBTYPE OF OBSESSIVE-COMPULSIVE DISORDER (TOURETTIC OCD). (TORCH)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dipesh Patel, MPhil / PhD
- Phone Number: +44 (0)20 3456 7890
- Email: dipesh.patel.23@ucl.ac.uk
Study Locations
-
-
London
-
London, London, United Kingdom, WC1N 3BG
- Recruiting
- University College London Queen Square Institute of Neurology
-
Contact:
- Dipesh Patel, MPhil / PhD
- Phone Number: +44 (0)20 3456 7890
- Email: dipesh.patel.23@ucl.ac.uk
-
Principal Investigator:
- Himanshu Tyagi, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years.
- Either Gender
- Confirmation of a primary diagnosis of either:
a. Tourette's Disorder (DSM-5 307.23 F95.2) b. Persistent Motor or Vocal Tic Disorder (DSM-5 307.22 F95.1) c. Provisional Tic Disorder (DSM-5 307.21 F95.0) d. Other Specified Tic Disorder (DSM-5 307.20 F95.8) e. Unspecified Tic Disorder (DSM-5 307.20 F95.9) f. Obsessive-Compulsive Disorder (DSM-5 300.3 F42.2) [d] Medication use is not an exclusion criterion (type of medication and daily dosages are to remain unchanged throughout the trial intervention period) [e] Ability to provide sustained informed consent [f] A minimum score of 16 on YBOCS [g] A minimum score of 5 on the Premonitory Urge for Tics Scale (PUTS)
Exclusion Criteria:
- Substance misuse (DSM 483)
- Adult personality disorder (DSM 645) (301.0 - 301.9)
- Schizophrenia (DSM 297.1 - 298.9)
- Bipolar disorder (DSM 296.89 - 296.80)
- Contraindications to participation in a trial (i.e., active suicidal ideations and/or requirement of an interpreter)
- Other diagnostic contraindication(s)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Combined Exposure and Response Prevention and Habit Reversal
Participants allocated to this arm will receive a 12-week individual psychological intervention integrating Exposure and Response Prevention (ERP) and Habit Reversal Training (HRT).
ERP will involve planned exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while reducing compulsions, avoidance, reassurance seeking, and other safety behaviours.
HRT will include awareness training, identification of premonitory urges and tic-related cues, development and practice of competing responses, and strategies to support generalisation.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
|
Exposure and Response Prevention (ERP) is a behavioural intervention that involves gradual and systematic exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while refraining from compulsions, avoidance, reassurance seeking, and other safety behaviours.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
Habit Reversal Training (HbRT) is a behavioural intervention that includes awareness training, identification of premonitory urges and antecedents to tic expression, development and practice of competing responses, and strategies to generalise skills across settings.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
|
|
Active Comparator: Standarised Exposure and Response Prevention Alone
Participants allocated to this arm will receive a 12-week individual psychological intervention based on Exposure and Response Prevention (ERP).
Treatment will involve gradual and systematic exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while refraining from compulsions, avoidance, reassurance seeking, and other safety behaviours.
The intervention aims to reduce obsessive-compulsive symptoms by promoting inhibitory learning and increasing tolerance of uncertainty and internal experiences.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
|
Exposure and Response Prevention (ERP) is a behavioural intervention that involves gradual and systematic exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while refraining from compulsions, avoidance, reassurance seeking, and other safety behaviours.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
|
|
Active Comparator: Standarised Habit Reversal Alone
Participants allocated to this arm will receive a 12-week individual psychological intervention based on Habit Reversal Training (HbRT).
Treatment will include awareness training to improve recognition of tics and premonitory urges, identification of antecedents and contextual triggers, development and practice of competing responses, and strategies to promote generalisation of skills to everyday settings.
The intervention aims to reduce tic severity and improve voluntary tic management.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
|
Habit Reversal Training (HbRT) is a behavioural intervention that includes awareness training, identification of premonitory urges and antecedents to tic expression, development and practice of competing responses, and strategies to generalise skills across settings.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
|
|
Active Comparator: Psychoeducation / Supportive Intervention
Participants allocated to this arm will receive a 12-week individual psychological intervention consisting of psychoeducation and supportive therapy.
Sessions will provide information about obsessive-compulsive disorder, tic disorders, Tourettic obsessive-compulsive disorder, stress, and wellbeing, together with supportive discussion and general problem-solving.
This intervention will not include structured Exposure and Response Prevention, Habit Reversal Training, or other targeted behavioural techniques.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
|
Psychoeducation and Supportive Therapy consists of structured education about obsessive-compulsive disorder, tic disorders, Tourettic obsessive-compulsive disorder, stress, and wellbeing, together with supportive discussion and general problem-solving.
The intervention does not include Exposure and Response Prevention, Habit Reversal Training, or other targeted behavioural techniques.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Total Score
Time Frame: Baseline, Week 12 and Week 24
|
Obsessive-compulsive symptom severity will be measured using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
The Y-BOCS total score ranges from 0 to 40, with higher scores indicating greater obsessive-compulsive symptom severity.
Change from baseline will be assessed at the end of treatment and follow-up.
|
Baseline, Week 12 and Week 24
|
|
Change From Baseline in Yale Global Tic Severity Scale Total Tic Severity Score
Time Frame: Baseline, Week 12 and Week 24
|
Tic symptom severity will be measured using the Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score.
The score ranges from 0 to 50, with higher scores indicating greater tic severity.
Change from baseline will be assessed at the end of treatment and follow-up.
|
Baseline, Week 12 and Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Impairment Score
Time Frame: Baseline, Week 12 and Week 24
|
Functional impairment associated with obsessive-compulsive symptoms will be measured using the impairment items of the Yale-Brown Obsessive Compulsive Scale.
Higher scores indicate greater impairment.
Change from baseline will be assessed at the end of treatment and follow-up.
|
Baseline, Week 12 and Week 24
|
|
Change From Baseline in Yale Global Tic Severity Scale Impairment Score
Time Frame: Baseline, Week 12 and Week 24
|
Tic-related functional impairment will be measured using the Yale Global Tic Severity Scale Impairment Score.
The score ranges from 0 to 50, with higher scores indicating greater impairment.
Change from baseline will be assessed at the end of treatment and follow-up.
|
Baseline, Week 12 and Week 24
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Neurodevelopmental Disorders
- Movement Disorders
- Heredodegenerative Disorders, Nervous System
- Basal Ganglia Diseases
- Personality Disorders
- Anxiety Disorders
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Tic Disorders
- Tourette Syndrome
Other Study ID Numbers
- ERP/HR TOCD RTC - 177187
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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