ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy in Obsessive-compulsive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICBT.
- Who it may be relevant to
- Registry conditions: Obsessive-Compulsive Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy from Changes in the Neurobiological Correlates of Emotion Regulation in Obsessive-compulsive Disorder
Overview
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
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.
Interventions
- Behavioral ICBT
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.
Primary outcome measures
- Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [Time frame: immediately before and immediately after intervention/waitlist]
Secondary outcome measures (11)
- Obsessive-Compulsive Inventory- Revised [Time frame: 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 [Time frame: immediately before and immediately after intervention/waitlist]
- Hamilton Depression Scale [Time frame: immediately before and immediately after intervention/waitlist]
- Perceived Stress Scale [Time frame: immediately before and immediately after intervention/waitlist]
- Emotion Regulation Questionnaire [Time frame: immediately before and immediately after intervention/waitlist]
- Difficulties in Emotion Regulation Scale [Time frame: immediately before and immediately after intervention/waitlist]
- Positive and Negative Affect Schedule [Time frame: immediately before and immediately after intervention/waitlist]
- Depression Anxiety Stress scale [Time frame: baseline; every week during intervention/wait list (up to 14 weeks) and immediately after intervention/waitlist]
- NEO Five-Factor Inventory [Time frame: baseline]
- Treatment Acceptability/Adherence Scale [Time frame: immediately after intervention]
- University of Rhode Island Change Assessment Scale [Time frame: baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Portugal · 1 center
- Life and Health Sciences Research Institute, School of Medicine, University of Minho — Braga
Identifiers
NCT: NCT05906069 · iTREATOCD_ICVS2022