ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy in Obsessive-compulsive Disorder (iTREATOCD)

ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy from Changes in the Neurobiological Correlates of Emotion Regulation in Obsessive-compulsive Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: ICBT

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedro Morgado, M.D, Ph.D.; Phone Number: +351 253 604 931; Email: pedromorgado@med.uminho.pt
• Study Contact Backup: Name: Mafalda Sousa, M., Sc.; Email: id9534@alunos.uminho.pt

Study Locations

• Portugal
  • Gualtar
    • Braga, Gualtar, Portugal, 4710-057
      • Recruiting
      • Life and Health Sciences Research Institute, School of Medicine, University of Minho
      • Contact: Pedro Morgado, M.D, Ph.D.; Phone Number: 00351 253 604 931; Email: pedromorgado@med.uminho.pt
      • Contact: Mafalda Sousa, M. Sc.; Email: id9534@alunos.uminho.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iCBT intervention; 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; 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.
No Intervention: Wait list; Participants will be enrolled in the iCBT program after 14 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pedro Morgado
• Collaborators: Hospital de Braga; Clinical Academic Center (2CA); ICVS - Life and Health Sciences Research Institute; Associação Centro de Medicina P5 (ACMP5)
• Investigators: Principal Investigator: Pedro Morgado, M.D, Ph.D., Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: obsessive-compulsive disorder; neuroimaging; emotion regulation; ocd; internet-based cognitive behavioral therapy
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: iTREATOCD_ICVS2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No