- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07725926
INTEGRATING EXPOSURE AND RESPONSE PREVENTION AND HABIT REVERSAL TECHNIQUES TO TREAT A TOURETTIC SUBTYPE OF OBSESSIVE-COMPULSIVE DISORDER (TOURETTIC OCD). (TORCH)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Dipesh Patel, MPhil / PhD
- Numero di telefono: +44 (0)20 3456 7890
- Email: dipesh.patel.23@ucl.ac.uk
Luoghi di studio
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London
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London, London, Regno Unito, WC1N 3BG
- Reclutamento
- University College London Queen Square Institute of Neurology
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Contatto:
- Dipesh Patel, MPhil / PhD
- Numero di telefono: +44 (0)20 3456 7890
- Email: dipesh.patel.23@ucl.ac.uk
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Investigatore principale:
- Himanshu Tyagi, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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.
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Comparatore attivo: 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.
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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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Yale-Brown Obsessive Compulsive Scale Total Score
Lasso di tempo: Baseline, Week 12 and Week 24
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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.
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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
Lasso di tempo: Baseline, Week 12 and Week 24
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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.
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Baseline, Week 12 and Week 24
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Yale-Brown Obsessive Compulsive Scale Impairment Score
Lasso di tempo: Baseline, Week 12 and Week 24
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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.
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Baseline, Week 12 and Week 24
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Change From Baseline in Yale Global Tic Severity Scale Impairment Score
Lasso di tempo: Baseline, Week 12 and Week 24
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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.
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Baseline, Week 12 and Week 24
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Disordini mentali
- Malattie genetiche, congenite
- Malattie Neurodegenerative
- Disturbi del neurosviluppo
- Disturbi del movimento
- Malattie Eredodegenerative, Sistema Nervoso
- Malattie dei gangli basali
- Disturbi della personalità
- Disturbi d'ansia
- Malattie e anomalie congenite, ereditarie e neonatali
- Disturbo compulsivo di personalità
- Disturbo ossessivo compulsivo
- Disturbi da tic
- Sindrome di Tourette
Altri numeri di identificazione dello studio
- ERP/HR TOCD RTC - 177187
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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