Towards Remission and Full Recovery From Obsessive-compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

— RCT2023  

Official title:

Towards Remission and Full Recovery From Obsessive-compulsive Disorder: Investigating the Efficacy of Inference-Based Cognitive-Behavioral Therapy When Standard Treatment Has Failed

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06318806
• Other study ID #: 2024-3633
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 30, 2029

Study information

• Verified date: March 2024
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: Frederick Aardema, PhD
• Phone: 514-662-5116
• Email: faardema[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Exposure and Response Prevention (ERP) improves symptoms in a significant proportion of patients, but only a minority reach remission after completing ERP (~40%). Also, ERP is a difficult treatment that requires requires deliberate and prolonged exposure to fearful stimuli and is associated with lower levels of acceptability and tolerability. The current trial aims to overcome these limitations with Inference-Based Cognitive-Behavioral therapy (I-CBT) - a specialized form of Cognitive Behavioral Therapy that does not require provoking anxiety through exposure to fearful stimuli. To meet our objective, the current study consists of a randomized controlled trial preceded by a run-in treatment with ERP with a total of 160 patients diagnosed with OCD. Those that fail to reach remission with the run-in treatment (est. 60%) will be randomly allocated to either 18 sessions of ICBT or continued treatment with ERP. Patients will be diagnosed by standardized semi-structured interviews and treatment outcome will be assessed by gold standard clinician rated measurement of severity of symptoms by independent evaluators. For our first hypothesis we predict that I-CBT is superior to continued ERP among those who have previously failed to reach remission with ERP in terms of: (a) greater improvement on our principal continuous outcome measure of OCD severity at post-treatment and follow-up; (b) clinical status at post-treatment and follow-up (treatment response, remission and relapse). For our second hypothesis we predict that I-CBT is more acceptable and tolerable as compared to continued treatment with ERP for those previously unable to benefit sufficiently from ERP. For our third hypothesis, we predict that I-CBT is associated with more improvement on our secondary measures of outcome, including a) OC symptom dimensions and negative mood states, b) obsessive beliefs and reasoning processes, and c) psychosocial functioning. For our fourth hypothesis, we predict that ERP is associated with a higher frequency of combined treatment refusal and drop-out rates as compared to I-CBT. For our fifth hypothesis, we predict that treatment outcome during ERP and I-CBT is associated with improvements in inferential confusion and feared-self perceptions. The secondary objective of the current proposal is to identify predictors of outcome and to use supervised machine learning to forecast which patients fail to reach remission following initial ERP treatment in order to enable the selection of patients to administer I-CBT as a first-line treatment in the future. Predictors will consist of previously identified risk factors of negative outcome, as well as proposed candidates in the extant literature

Recruitment information / eligibility

• 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,

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Other:
• Psychological
Psychotherapy is a type of treatment that can help individuals experiencing mental health conditions and emotional challenges.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal	Canadian Institutes of Health Research (CIHR)

Outcome

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