- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07725926
Integrating Exposure and Response Prevention and Habit Reversal Techniques to Treat a Tourettic Subtype of Obsessive-Compulsive Disorder (Tourettic OCD) (TORCH)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Dipesh Patel, MPhil / PhD
- Numéro de téléphone: +44 (0)20 3456 7890
- E-mail: dipesh.patel.23@ucl.ac.uk
Lieux d'étude
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London
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London, London, Royaume-Uni, WC1N 3BG
- Recrutement
- University College London Queen Square Institute of Neurology
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Contact:
- Dipesh Patel, MPhil / PhD
- Numéro de téléphone: +44 (0)20 3456 7890
- E-mail: dipesh.patel.23@ucl.ac.uk
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Chercheur principal:
- Himanshu Tyagi, PhD
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London, London, Royaume-Uni, WC1N 3BG
- Recrutement
- University College London Hospitals NHS Foundation Trust
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Contact:
- Dipesh Patel, MPhil / PhD
- Numéro de téléphone: +44 (0)20 3456 7890
- E-mail: dipesh.patel.23@ucl.ac.uk
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age 18 years or older
- All genders
- Confirmation of a primary diagnosis of either:
a. Tourettes Disorder / Tourette Syndrome b. Persistent Motor or Vocal Tic Disorder / Chronic Motor or Vocal Tic Disorder c. Provisional Tic Disorder / Transient Motor Tics d. Other Specified Tic Disorder e. Unspecified Tic Disorder f. Obsessive-Compulsive Disorder [d] Participants taking psychotropic medication are eligible provided medication type and dose remain stable throughout the 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
- Current diagnosis of a personality disorder
- Schizophrenia
- Bipolar disorder
- Contraindications to participation in a trial (i.e., active suicidal ideations and/or requirement of an interpreter)
- Any psychiatric or neurological condition that, in the opinion of the investigators, would interfere with participation or interpretation of study outcomes.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Comparateur actif: 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.
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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.
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Comparateur actif: Standardised Exposure and Response Prevention
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.
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Comparateur actif: Standardised Habit Reversal
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Baseline in Yale-Brown Obsessive Compulsive Scale Total Score
Délai: Baseline, Week 12 and Week 24
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Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
Total scores range from 0 to 40, with higher scores indicating greater obsessive-compulsive symptom severity.
Change from baseline will be assessed at Week 12 and Week 24.
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Baseline, Week 12 and Week 24
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Change From Baseline in Yale Global Tic Severity Scale Total Tic Severity Score
Délai: Baseline, Week 12 and Week 24
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Tic symptom severity will be assessed using the Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score.
Scores range from 0 to 50, with higher scores indicating greater tic symptom severity.
Change from baseline will be assessed at Week 12 and Week 24.
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Baseline, Week 12 and Week 24
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Baseline in Yale Global Tic Severity Scale Global Severity Score
Délai: Baseline, Week 12 and Week 24
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Overall tic symptom severity and tic-related impairment will be assessed using the Yale Global Tic Severity Scale (YGTSS) Total Score.
The Global Score is calculated by summing the Total Tic Severity Score (0-50) and the Impairment Score (0-50), resulting in a global score ranging from 0 to 100.
Higher scores indicate greater overall tic severity and impairment.
Change from baseline will be assessed at Week 12 and Week 24.
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Baseline, Week 12 and Week 24
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Les troubles mentaux
- Maladies génétiques, innées
- Maladies neurodégénératives
- Troubles neurodéveloppementaux
- Troubles du mouvement
- Troubles hérédodégénératifs, système nerveux
- Maladies des noyaux gris centraux
- Troubles de la personnalité
- Troubles anxieux
- Maladies et anomalies congénitales, héréditaires et néonatales
- Trouble de la personnalité compulsive
- Trouble obsessionnel compulsif
- Troubles du tic
- Syndrome de la Tourette
Autres numéros d'identification d'étude
- ERP/HR TOCD RTC - 177187
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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