Obsessive-Compulsive Disorder Clinical Trial
— RCT2023Official title:
Towards Remission and Full Recovery From Obsessive-compulsive Disorder: Investigating the Efficacy of Inference-Based Cognitive-Behavioral Therapy When Standard Treatment Has Failed
Obsessive-compulsive disorder (OCD) is a disabling psychiatric illness that is characterized by distressing obsessional thoughts and time-consuming compulsive rituals. Exposure and Response Prevention (ERP) is a first-line psychological treatment of choice that requires patients to face their fears by being exposed to feared stimuli. This treatment has been shown to reduce symptoms in a significant proportion of patients. However, it is considered a difficult treatment and only a minority reach remission. Residual symptoms typically remain, or reappear after treatment, which is a risk for relapse. Inference-based Cognitive Behavioral Therapy (I-CBT) is a promising evidence-based treatment developed to overcome these limitations. I-CBT has already been found to be as effective as ERP and significantly more acceptable and easier to adhere to. There is also evidence that I-CBT is more effective for subgroups of patients. Consequently, the current research project is focused on improving treatments outcomes for those provide those who have previously unable to reach remission of their symptoms with ERP. Following an initial treatment with ERP, those that have been unable to reach remission, will be randomized to either I-CBT or more ERP. It is expected that I-CBT will be significantly more effective than providing patients with more of the same. In addition, the study aims to predict treatment outcome in order to be able to tell in advance which patients do not respond to ERP. The project is designed to maximize beneficial health outcomes with a stepped-care approach to treatment, but also to work towards a more personalized choice by being able to match patients in advance with the treatment that works best for them
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | September 30, 2029 |
Est. primary completion date | September 30, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Eligibility criteria for participation in the trial includes: (a) a primary diagnosis of OCD according to DSM-5 criteria, b) a score = 18 on the Y-BOCS (c) age = 18; (d) no change in medication during the 8 weeks before treatment for antidepressants (4 weeks for anxiolytics), (e) willingness to keep medication stable while participating in the study, (f) no evidence of a high level of suicidal ideation, suicidal intent or previous suicide attempts, (g) no past or present psychotic or bipolar disorder, (h) no neurocognitive disorder, pervasive developmental disorder or intellectual disability of a severity judged to significantly interfere with treatment and/or requiring treatment first, (i) no evidence of a substance abuse disorder of a severity judged to significantly interfere with treatment and/or requiring treatment first; (i) not undergoing a concurrent psychological treatment, (j) access to a computer or phone with internet access, |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ciusss de L'Est de l'Île de Montréal | Canadian Institutes of Health Research (CIHR) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Yale-Brown Obsessive-Compulsive Scale -2 (Y-BOCS-2) | he Yale-Brown Obsessive-Compulsive Scale - 2 is the instrument of choice to assess obsessive compulsive symptoms and severity. | Baseline, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2 after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-up, change after 12-month follow-up | |
Primary | Clinical Global Impression Scale (CGI) | The clinical global impression rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. | Baseline, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2 after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-up, change after 12-month follow-up | |
Secondary | Vancouver Obsessional Compulsive Inventory (VOCI) | The Vancouver Obsessional Compulsive Inventory (VOCI) to assess a broad spectrum of OCD symptoms and associated personality characteristics.It is a 55-item self-report measure to assess a broad spectrum of OCD symptoms and associated personal | Baseline, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2 after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-up, change after 12-month follow-up | |
Secondary | Beck Depression Inventory (BDI) | The Beck Depression Inventory (BDI) is a standard 21-item measure to assess depressive symptoms. | Baseline, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2 after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-up, change after 12-month follow-up | |
Secondary | Beck Anxiety Inventory (BAI) | The Beck Anxiety Inventory (BAI) is a standard 21-item anxiety symptom checklist rating anxiety symptom intensity for the last week on a 0-3 scale. | Baseline, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2 after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-up, change after 12-month follow-up | |
Secondary | Inferential Confusion Questionnaire (ICQ) | The ICQ was originally developed in French and is a 30-item questionnaire. | After baseline before treatment, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2 after 9 weeks of treatment, change in phase 2 after 18 weeks of treatmen | |
Secondary | Dysfunctional Reasoning Processes Task (DRPT) | The Dysfunctional Reasoning Processes Task (DRPT) is used to investigate the relationship of inferential confusion with feared self-perceptions and symptoms of OCD. | After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment | |
Secondary | Fear of Self Questionnaire (FSQ-20) | The Fear of Self Questionnaire (FSQ) is used to measure the potential relevance of fear of self to obsessional compulsive symptoms. | After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment | |
Secondary | Obsessive Beliefs Questionnaire (OBQ-20) | The Obsessive Beliefs Questionnaire (OBQ-44) is a 44-item measure developed by the Obsessive Compulsive Cognitions Working Group between 1995 and 1998. The OBQ consist in three twinned domains based on the working group consensus (over-responsibility/over-estimation of threat, intolerance of uncertainty/over-importance of thought, control of thoughts/perfectionism). | After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment | |
Secondary | Brunnsviken Brief Quality of Life Scale (BBQ) | The Brunnsviken Brief Quality of Life Scale (BBQ) is a 12 item self-report questionnaire that assesses subjective quality of life across six life areas: Leisure, View on Life, Creativity, Learning, Friends and Friendship, and View on Self. | After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment | |
Secondary | Sheehan Disability Scale | The Sheehan Disability Scale measures the functional capacity at the professional, social and family level of the participant/patient. | Baseline, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2 after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-up, change after 12-month follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04934007 -
Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
|
N/A | |
Recruiting |
NCT04071990 -
Family Involvement in CBGT of OCD: a Randomized Controlled Trial
|
N/A | |
Completed |
NCT02541968 -
Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder
|
N/A | |
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Recruiting |
NCT05391503 -
Light Therapy for Obsessive-compulsive Disorder (OCD)
|
N/A | |
Recruiting |
NCT04539951 -
Pragmatic Trial of Obsessive-compulsive Disorder
|
Phase 2 | |
Completed |
NCT03416504 -
Methods for Managing Intrusive Thoughts
|
N/A | |
Not yet recruiting |
NCT06029738 -
Effect on Obsessive-Compulsive Beliefs and Symptoms of MCT-OCD
|
N/A | |
Recruiting |
NCT02844049 -
European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS
|
N/A | |
Terminated |
NCT02909660 -
What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder
|
N/A | |
Completed |
NCT02911324 -
Cannabinoid Medication for Adults With OCD
|
Phase 1/Phase 2 | |
Terminated |
NCT02234011 -
A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder
|
Phase 2 | |
Completed |
NCT02217995 -
Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients
|
N/A | |
Withdrawn |
NCT01953042 -
Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
|
N/A | |
Completed |
NCT02655926 -
Deep Brain Stimulation for Severe Obsessive Compulsive Disorder
|
N/A | |
Completed |
NCT00742664 -
Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project
|
Phase 1/Phase 2 | |
Completed |
NCT04919785 -
Deep Brain Stimulation in Severe Obsessive-compulsive Disorder
|
N/A | |
Terminated |
NCT00758966 -
Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder
|
Phase 2 | |
Completed |
NCT00523718 -
Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder
|
Phase 2 | |
Completed |
NCT00074815 -
Treatment of Obsessive Compulsive Disorder in Children
|
Phase 3 |