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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05906069
Acronym
iTREATOCD
Enrollment
120
Registered
2023-06-15
Start date
2023-05-02
Completion date
2025-12-31
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder

Keywords

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

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.

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

BEHAVIORALICBT

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.

Sponsors

Hospital de Braga
CollaboratorOTHER
ICVS - Life and Health Sciences Research Institute
CollaboratorUNKNOWN
Clinical Academic Center (2CA)
CollaboratorUNKNOWN
Associação Centro de Medicina P5 (ACMP5)
CollaboratorUNKNOWN
Pedro Morgado
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The psychologist performing the assessment of the main psychometric outcomes will be blind to the group allocation of each participant.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)immediately before and immediately after intervention/waitlistPsychometric scale to assess obsessive-compulsive symptoms

Secondary

MeasureTime frameDescription
Hamilton Anxiety Scaleimmediately before and immediately after intervention/waitlistPsychometric scale to assess anxiety symptoms
Hamilton Depression Scaleimmediately before and immediately after intervention/waitlistPsychometric scale to assess depression symptoms
Perceived Stress Scaleimmediately before and immediately after intervention/waitlistPsychometric scale to assess stress symptoms
Emotion Regulation Questionnaireimmediately before and immediately after intervention/waitlistPsychometric scale to assess cognitive regulation and emotional suppression capabilities
Difficulties in Emotion Regulation Scaleimmediately before and immediately after intervention/waitlistPsychometric scale to assess emotion deregulation
Obsessive-Compulsive Inventory- Revisedbaseline; 4 weeks after beginning intervention/waitlist; 8 weeks after beginning; 12 weeks after beginning intervention/waitlist and immediately after intervention/waitlistPsychometric scale to assess obsessive-compulsive symptoms
Depression Anxiety Stress scalebaseline; every week during intervention/wait list (up to 14 weeks) and immediately after intervention/waitlistPsychometric scale to assess symptoms of anxiety, depression and stress
NEO Five-Factor InventorybaselinePsychometric scale to assess personality traits
Treatment Acceptability/Adherence Scaleimmediately after interventionPsychometric scale to assess treatment adherence
University of Rhode Island Change Assessment ScalebaselinePsychometric scale to assess motivation to change
Positive and Negative Affect Scheduleimmediately before and immediately after intervention/waitlistPsychometric scale to assess affect

Countries

Portugal

Contacts

Primary ContactPedro Morgado, M.D, Ph.D.
pedromorgado@med.uminho.pt+351 253 604 931
Backup ContactMafalda Sousa, M., Sc.
id9534@alunos.uminho.pt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026