iTreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy in Obsessive-compulsive Disorder

Study Overview
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Brief Summary
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In the current study, the investigators will characterize obsessive-compulsive disorder (OCD) patients and healthy controls with a comprehensive clinical and neuroimaging assessment, focusing on the basic psychological processes related and on the neurobiological underpinnings of emotion regulation (ER). After a baseline assessment, the investigators will implement an internet-based cognitive behavioral therapy (iCBT) protocol and assess its efficacy on the modulation of ER and OCD severity. Specifically, the investigators will (1) examine to what extent the iCBT intervention modulates ER and the associated neurobiological mechanisms and (2) identify candidate biomarkers of successful treatment response.

Detailed Description
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Sixty patients and sixty controls will be recruited at Hospital de Braga, Braga, Portugal (sample size estimated based on a previous systematic review). A power analysis indicated that a sample of 24 individuals per group is adequate to detect an effect size of d=.89, with a Type I error of .05 and a statistical power of .85. A final sample of 30 individuals was defined to account for a 20% dropout rate during the intervention. All participants will be assessed with a comprehensive psychological and clinical characterization. Following the baseline assessment, OCD patients will be randomly allocated to the intervention (iCBT intervention) or the control group (waiting list). The iCBT intervention will consist of a structured program comprising 10 modules with text and video content, as well as 3 videoconferencing psychotherapy sessions. After the intervention/waiting list, patients will be re-assessed with the clinical and psychological assessment. In order to characterize the patterns of brain activation in OCD patients during an emotion regulation task in comparison to healthy controls and to identify potential neurobiological markers of symptoms' improvement, a multimodal neuroimaging assessment will also be performed. The task encompasses the presentation of pictures (fearful, neutral and OCD-related stimuli) under two conditions: the instruction to view the pictures naturally ('observe'); or to apply cognitive reappraisal techniques to decrease any negative affective state caused by the stimuli ('regulate'). Fear and OCD-related pictures are presented during both conditions; neutral pictures only during 'observe'. After each stimulus, the level of distress will be assessed by a self-report rating scale. In the baseline assessment, brain activation patterns (with whole-brain and region of interest approaches) will be compared between OCD and healthy controls in both task conditions. After intervention, emotion regulation ability and the underlying neurobiological mechanisms will be compared between the 'intervention' and 'waiting list' groups.

Official Title
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iTreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy From Changes in the Neurobiological Correlates of Emotion Regulation in Obsessive-compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: ICBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of current OCD according to the fifth Diagnostic and Statistical Manual of Mental Disorders YBOCS score ≥ 16 Psychotropic medication, if stable for at least 2 months prior to inclusion and if the dosage is maintained thoughout the study Have the resources to access the online intervention (internet access; computer or tablet) Exclusion Criteria: MRI contraindications Prior medical history of neurological disorders or traumatic brain injury Having performed CBT treatment for OCD in the last 2 years Undergoing any psychological treatment Suicidal ideation Current alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: OCD patients will be randomly allocated into two groups - iCBT group (experimental group) and wait list group (comparator control group). The experimental group will receive a 14-week iCBT intervention program and the wait list group will receive the same intervention but at a later time.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCBT intervention<br>Participants will enroll in an internet-based cognitive behavioral program during 14 weeks. The program comprises 10 modules and three videoconferencing psychotherapy sessions. | Behavioral: ICBT<br>* The intervention will consist in a structured internet-based intervention with 10 modules that will combine cognitive-behavioral techniques to improve obsessive-compulsive symptoms as well as the emotion regulation ability.<br>|
| No Intervention: Wait list<br>Participants will be enrolled in the iCBT program after 14 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Psychometric scale to assess obsessive-compulsive symptoms | immediately before and immediately after intervention/waitlist | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obsessive-Compulsive Inventory- Revised | Psychometric scale to assess obsessive-compulsive symptoms | baseline; 4 weeks after beginning intervention/waitlist; 8 weeks after beginning; 12 weeks after beginning intervention/waitlist and immediately after intervention/waitlist | 
| Hamilton Anxiety Scale | Psychometric scale to assess anxiety symptoms | immediately before and immediately after intervention/waitlist | 
| Hamilton Depression Scale | Psychometric scale to assess depression symptoms | immediately before and immediately after intervention/waitlist | 
| Perceived Stress Scale | Psychometric scale to assess stress symptoms | immediately before and immediately after intervention/waitlist | 
| Emotion Regulation Questionnaire | Psychometric scale to assess cognitive regulation and emotional suppression capabilities | immediately before and immediately after intervention/waitlist | 
| Difficulties in Emotion Regulation Scale | Psychometric scale to assess emotion deregulation | immediately before and immediately after intervention/waitlist | 
| Positive and Negative Affect Schedule | Psychometric scale to assess affect | immediately before and immediately after intervention/waitlist | 
| Depression Anxiety Stress scale | Psychometric scale to assess symptoms of anxiety, depression and stress | baseline; every week during intervention/wait list (up to 14 weeks) and immediately after intervention/waitlist | 
| NEO Five-Factor Inventory | Psychometric scale to assess personality traits | baseline | 
| Treatment Acceptability/Adherence Scale | Psychometric scale to assess treatment adherence | immediately after intervention | 
| University of Rhode Island Change Assessment Scale | Psychometric scale to assess motivation to change | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obsessive-compulsive disorder, ocd, neuroimaging, emotion regulation, internet-based cognitive behavioral therapy