- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07725926
INTEGRATING EXPOSURE AND RESPONSE PREVENTION AND HABIT REVERSAL TECHNIQUES TO TREAT A TOURETTIC SUBTYPE OF OBSESSIVE-COMPULSIVE DISORDER (TOURETTIC OCD). (TORCH)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Dipesh Patel, MPhil / PhD
- Telefonnummer: +44 (0)20 3456 7890
- E-mail: dipesh.patel.23@ucl.ac.uk
Studiesteder
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London
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London, London, Det Forenede Kongerige, WC1N 3BG
- Rekruttering
- University College London Queen Square Institute of Neurology
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Kontakt:
- Dipesh Patel, MPhil / PhD
- Telefonnummer: +44 (0)20 3456 7890
- E-mail: dipesh.patel.23@ucl.ac.uk
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Ledende efterforsker:
- Himanshu Tyagi, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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Aktiv komparator: 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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Aktiv komparator: 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.
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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Yale-Brown Obsessive Compulsive Scale Total Score
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Yale-Brown Obsessive Compulsive Scale Impairment Score
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Psykiske lidelser
- Genetiske sygdomme, medfødte
- Neurodegenerative sygdomme
- Neuroudviklingsforstyrrelser
- Bevægelsesforstyrrelser
- Heredodegenerative lidelser, nervesystem
- Basal Ganglia Sygdomme
- Personlighedsforstyrrelser
- Angstlidelser
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Kompulsiv personlighedsforstyrrelse
- Tvangslidelse
- Tic lidelser
- Tourettes syndrom
Andre undersøgelses-id-numre
- ERP/HR TOCD RTC - 177187
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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