Obsessive-Compulsive DisorderiTREATOCDNCT05906069
ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy in Obsessive-compulsive Disorder
A study testing ICBT in people with Obsessive-Compulsive Disorder, run by Pedro Morgado at 1 site in Portugal.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- ICBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePortugal
- Study dates
- 2 May 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mafalda Sousa, M., Sc. contact
Portugal1 site, 1 recruiting
- Recruiting
Life and Health Sciences Research Institute, School of Medicine, University of Minho
Braga, Gualtar, 4710-057
Pedro Morgado, M.D, Ph.D., 00351 253 604 931, pedromorgado@med.uminho.pt
Mafalda Sousa, M. Sc., id9534@alunos.uminho.pt
About this study
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
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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- ICBT
- Keywords
- obsessive-compulsive disorder, ocd, neuroimaging, emotion regulation, internet-based cognitive behavioral therapy
- Medical subject headings
- Obsessive-Compulsive Disorder, Compulsive Personality Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ICBT |
| Wait list | No intervention | Participants will be enrolled in the iCBT program after 14 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Psychometric scale to assess obsessive-compulsive symptoms
Measured: immediately before and immediately after intervention/waitlist
Secondary outcomes (11)
Obsessive-Compulsive Inventory- Revised
Psychometric scale to assess obsessive-compulsive symptoms
Measured: 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
Measured: immediately before and immediately after intervention/waitlist
Hamilton Depression Scale
Psychometric scale to assess depression symptoms
Measured: immediately before and immediately after intervention/waitlist
Perceived Stress Scale
Psychometric scale to assess stress symptoms
Measured: immediately before and immediately after intervention/waitlist
Emotion Regulation Questionnaire
Psychometric scale to assess cognitive regulation and emotional suppression capabilities
Measured: immediately before and immediately after intervention/waitlist
Difficulties in Emotion Regulation Scale
Psychometric scale to assess emotion deregulation
Measured: immediately before and immediately after intervention/waitlist
Positive and Negative Affect Schedule
Psychometric scale to assess affect
Measured: immediately before and immediately after intervention/waitlist
Depression Anxiety Stress scale
Psychometric scale to assess symptoms of anxiety, depression and stress
Measured: 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
Measured: baseline
Treatment Acceptability/Adherence Scale
Psychometric scale to assess treatment adherence
Measured: immediately after intervention
University of Rhode Island Change Assessment Scale
Psychometric scale to assess motivation to change
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start2 May 2023
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pedro Morgado
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Braga, ICVS - Life and Health Sciences Research Institute, Clinical Academic Center (2CA), Associação Centro de Medicina P5 (ACMP5)
- Responsible party
- Sponsor-investigator, Pedro Morgado, University of Minho
- Investigators
- Pedro Morgado, M.D, Ph.D., Principal investigator, Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906069
- Sponsor's protocol ID
- iTREATOCD_ICVS2022
- Acronym
- iTREATOCD
- Status last verified
- Jan 2025
- First submitted
- 16 May 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05906069
- Acronym / sponsor ID
- iTREATOCD / iTREATOCD_ICVS2022
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- obsessive-compulsive disorder, ocd, neuroimaging, emotion regulation, internet-based cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pedro MorgadoUniversity, hospital or other
- Collaborators
- Hospital de Braga, ICVS - Life and Health Sciences Research Institute, Clinical Academic Center (2CA), Associação Centro de Medicina P5 (ACMP5)
- Study start
- 2 May 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| iCBT intervention | Experimental | Behavioral: ICBTParticipants will enroll in an internet-based cognitive behavioral program during 14 weeks. The program comprises 10 modules and three videoconferencing psychotherapy sessions. |
| Wait list | No intervention | –Participants will be enrolled in the iCBT program after 14 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICBTThe 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. | Behavioural | iCBT intervention |
Primary outcome
Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: immediately before and immediately after intervention/waitlist
Psychometric scale to assess obsessive-compulsive symptoms
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mafalda Sousa, M., Sc. contact
Pedro Morgado, M.D, Ph.D. principal investigator
Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICBT in people with Obsessive-Compulsive Disorder, run by Pedro Morgado at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro Morgado, M.D, Ph.D. (+351 253 604 931, pedromorgado@med.uminho.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: immediately before and immediately after intervention/waitlist). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.