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

NCT05906069 | Recruiting

• 1 other identifier: iTREATOCD_ICVS2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

obsessive-compulsive disorder; ocd; neuroimaging; emotion regulation; internet-based cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Obsessive-Compulsive Inventory- Revised

  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

  immediately before and immediately after intervention/waitlist

• Hamilton Depression Scale

  immediately before and immediately after intervention/waitlist

• Perceived Stress Scale

  immediately before and immediately after intervention/waitlist

• Emotion Regulation Questionnaire

  immediately before and immediately after intervention/waitlist

Study Arms (2)

iCBT intervention

EXPERIMENTAL

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

Wait list

NO INTERVENTION

Participants will be enrolled in the iCBT program after 14 weeks

Interventions

ICBT BEHAVIORAL

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.

iCBT intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of current OCD according to the fifth Diagnostic and Statistical Manual of Mental Disorders
• YBOCS score ≥ 16
• Have the resources to access the online intervention (internet access; computer or tablet)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pedro Morgado: lead
• Hospital de Braga: collaborator
• ICVS - Life and Health Sciences Research Institute: collaborator
• Clinical Academic Center (2CA): collaborator
• Associação Centro de Medicina P5 (ACMP5): collaborator

Study Sites (1)

Life and Health Sciences Research Institute, School of Medicine, University of Minho

Braga, Gualtar, 4710-057, Portugal

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Compulsive Personality Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Personality Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Pedro Morgado, M.D, Ph.D.

  Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Morgado, M.D, Ph.D.

CONTACT

+351 253 604 931; pedromorgado@med.uminho.pt

Mafalda Sousa, M., Sc.

CONTACT

id9534@alunos.uminho.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The psychologist performing the assessment of the main psychometric outcomes will be blind to the group allocation of each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, M.D., Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 15, 2023
• Study Start: May 2, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)