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- Klinische proef NCT07725926
Integrating Exposure and Response Prevention and Habit Reversal Techniques to Treat a Tourettic Subtype of Obsessive-Compulsive Disorder (Tourettic OCD) (TORCH)
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Dipesh Patel, MPhil / PhD
- Telefoonnummer: +44 (0)20 3456 7890
- E-mail: dipesh.patel.23@ucl.ac.uk
Studie Locaties
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London
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London, London, Verenigd Koninkrijk, WC1N 3BG
- Werving
- University College London Queen Square Institute of Neurology
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Contact:
- Dipesh Patel, MPhil / PhD
- Telefoonnummer: +44 (0)20 3456 7890
- E-mail: dipesh.patel.23@ucl.ac.uk
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Hoofdonderzoeker:
- Himanshu Tyagi, PhD
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London, London, Verenigd Koninkrijk, WC1N 3BG
- Werving
- University College London Hospitals NHS Foundation Trust
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Contact:
- Dipesh Patel, MPhil / PhD
- Telefoonnummer: +44 (0)20 3456 7890
- E-mail: dipesh.patel.23@ucl.ac.uk
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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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Actieve vergelijker: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change From Baseline in Yale-Brown Obsessive Compulsive Scale Total Score
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change From Baseline in Yale Global Tic Severity Scale Global Severity Score
Tijdsspanne: 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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Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Psychische aandoening
- Genetische ziekten, aangeboren
- Neurodegeneratieve ziekten
- Neurologische ontwikkelingsstoornissen
- Bewegingsstoornissen
- Heredodegeneratieve aandoeningen, zenuwstelsel
- Basale ganglia-ziekten
- Persoonlijkheidsstoornissen
- Angst stoornissen
- Aangeboren, erfelijke en neonatale ziekten en afwijkingen
- Dwangmatige persoonlijkheidsstoornis
- Obsessief-compulsieve stoornis
- Tic aandoeningen
- Tourette syndroom
Andere studie-ID-nummers
- ERP/HR TOCD RTC - 177187
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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