Obsessive-Compulsive Disorder (OCD)NCT04042038
Neural Predictors and Neural Changes Associated With Cognitive Behavior Therapy for Obssesive Compulsive Disorder
A study testing Cognitive-behavior therapy (psychological treatment) in people with Obsessive-Compulsive Disorder (OCD), run by Institut d'Investigació Biomèdica de Bellvitge at 3 sites in Spain.
Trial summary
The goals of the project are 1) to understand what are the neural mechanisms involved in the psychological treatment of obsessive-compulsive disorder (OCD) in children/adolescents and adults, 2) to assess potential differences in the neural mechanisms involved in the psychological treatment of OCD between… Read more about this study
- Who is it for?
- Ages 8 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder (OCD)
- What is being tested?
- Cognitive-behavior therapy (psychological treatment)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesSpain
- Study dates
- 1 May 2019to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Principal diagnosis of OCD;
- Y-BOCS or CYBOCS ≥ 16).
- No current psychotropic medication (except benzodiacepines for sleep). 4 ) Age between 8 and 17 years (Study 1) and between 18 and 60 years (Study 2).
Who cannot join
- Current major depression or current/past psychosis, bipolar disorder or substance abuse.
- Developmental disorders (including autistic spectrum disorders).
- To be pregnant or during breastfeeding
- Current CBT; nt.
- Any severe medical disorder ;
- Any contraindication for neuroimaging
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
IDIBAPS
Barcelona, 08036
Luisa Lázaro, MD, LLAZARO@clinic.cat
- Recruiting
IDIBELL
L'Hospitalet de Llobregat, Barcelona, 08907
Carles Soriano-Mas, PhD, 630835743 ext. 2889, csoriano@idibell.cat
- Recruiting
FIDMAG Germanes Hospitalàries
Sant Boi de Llobregat, Barcelona, 08035
Edith Pomarol-Clotet, MD, epomarol-clotet@fidmag.com
About this study
The goals of the project are 1) to understand what are the neural mechanisms involved in the psychological treatment of obsessive-compulsive disorder (OCD) in children/adolescents and adults, 2) to assess potential differences in the neural mechanisms involved in the psychological treatment of OCD between children/adolescents and adults, and 3) to assess the effectiveness of intensive CBT for children/adolescents and adults with OCD.
Read the detailed description
Obsessive-compulsive disorder (OCD) is a frequent and disabling disorder. Cognitive-behavior therapy (CBT) is the best treatment option available for OCD, although it achieves optimum results in less than half of the patients. The investigators will investigate the main neural circuits that predict CBT outcome in OCD and the neural changes associated with CBT in two separate randomized controlled trials (RCTs), one in an adult sample and another in a pediatric sample. In this two RCTs, OCD participants will be randomized to either intensive CBT (20 sessions in 1 month) by a experienced clinician or a waiting-list control (WLC) and will be assessed (by a blind assessor) and scanned before and after CBT. Patients will be offered CBT if they have been randomized to the WLC. At baseline, the investigators will also compare OCD patients with a group of healthy controls (HC). Secondary goals of the project include 1) assessing potential differences between children/adolescents and adults in the neural mechanisms involved in CBT for OCD; 2) assess the effectiveness of intensive CBT for children/adolescents and adults.
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Being tested
- Cognitive-behavior therapy (psychological treatment)
- Keywords
- Obsessive compulsive disorder, Intensive cognitive-behavioral therapy, Neuroimaging, Response prediction, Response mechanisms, Functional magnetic resonance imaging
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavior therapy (psychological treatment)Behavioural
Participants will receive up to 20 hours of manualized and structured CBT based on exposure and response prevention by experienced clinicians
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Intensive CBT (20 sessions in 1 month) Receives: Behavioral: Cognitive-behavior therapy (psychological treatment) |
| Waiting-list | No intervention | Waiting-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive-Compulsive Scale
The Yale-Brown Obsessive-Compulsive Scale evaluates the severity of Obsessive Compulsive Disorder symptoms in adults. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms) (total range, 0 to 40), with separate subtotals for severity of obsessions and compulsions.
Measured: Change from baseline to post-treatment (1 month)
Children´s Yale-Brown Obsessive-Compulsive Scale
The Children´s Yale-Brown Obsessive-Compulsive Scale evaluates the severity of Obsessive Compulsive Disorder symptoms in children/adolescents. The severity of the obsessions is rated on five Severity Items for Obsessions. Each of these five items is rated on a 5-point, ordinal scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme. These values are anchored by a description for each score. The Obsessions Severity Score is obtained by adding the scores for items 1 through 5 (range = 0 to 20).
There are five comparable Severity Items for Compulsions (items 6 through 10), which are also scored from 0 to 4. The Compulsions Severity Score is obtained by adding the scores of items 6 through 10 (range = 0 to 20). Summing the scores for all 10 items yields the CY-BOCS Total score (range = 0 to 40).
Measured: Change from baseline to post-treatment (1 month)
Secondary outcomes (4)
Obsessive-Compulsive Inventory-Revised
Obsessive-Compulsive Inventory-Revised is a self-report scale for assessing symptoms of Obsessive-Compulsive Disorder in adults. It consists of 18 questions that a person endorses on a 5-point Likert scale. Scores are generated by adding the item scores. The possible range of scores is 0-72. Mean score for persons with OCD is 28.0 (SD = 13.53). Recommended cutoff score is 21, with scores at or above this level indicating the likely presence of OCD.
Measured: Change from baseline to post-treatment (1 month)
Obsessive Compulsive Inventory-Child Version
Questionnaire assessing severity of obsessive-compulsive disorder symptoms children/adolescents. It is a 21-item self-report questionnaire, based on the 42-item adult version. Items are scored on a 3-point Likert scale. The measure is designed to evaluate obsessive-compulsive disorder in children between 7 and 17 years old. The total ranges from 0 to 42 points.
Measured: Change from baseline to post-treatment (1 month)
Children's Depression Inventory
The Children's Depression Inventory is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. It is a 27-item scale that is self-rated and symptom-oriented. The 27 items on the assessment are grouped into five major factor areas. Patients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.
Measured: Change from baseline to 1 month.
Spence Children's Anxiety Scale
The Spence Children's Anxiety Scale is a psychological questionnaire designed to identify symptoms of various anxiety disorders, specifically social phobia, obsessive-compulsive disorder, panic disorder/agorophobia, and other forms of anxiety, in children and adolescents between ages 8 and 15. There are 45 questions evaluating the frequency of certain anxiety symptoms, measured on a 0-3 scale from "never," "sometimes," often," to "always." A maximum score of 114 is possible on the child and parent-reported, and there are six subscales calculated within the final score. The total score is interpreted in different ways depending on the child's age and gender. For boys and girls ages 8-11, a total score of 40 and above or 50 and above is classified as elevated levels of anxiety, respectively. For boys and girls ages 12-15, a total score of 33 and above or 39 and above is classified as elevated, respectively.
Measured: Change from baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 May 2019
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive Disorder (OCD)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two separate (but methodologically identical) RCTs will be conducted, one in a sample of children/adolescents with OCD (study 1) and another in a sample of adults with OCD (study 2). Within each study, one group of age and gender-matched healthy controls will also serve as a comparison group at baseline (clinical and neuroimaging assessment). Within each study, after baseline assessment, OCD participants will be randomized to either intensive CBT or waiting list for one month. Then, OCD participants will be assessed again (clinical and neuroimaging assessment).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer, FIDMAG Germanes Hospitalàries
- Responsible party
- Principal investigator, Carles Soriano Mas, Institut d'Investigació Biomèdica de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042038
- Sponsor's protocol ID
- HCB/2018/0681
- Status last verified
- Feb 2023
- First submitted
- 30 Jul 2019
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hermida-Barros L, Garcia-Delgar B, Lera-Miguel S, Forcadell E, Moreno E, Prime-Tous M, Jaurrieta N, Segu X, Vilajosana E, Soriano-Mas C, de la Cruz LF, Vieta E, Radua J, Lazaro L, Fullana MA. Concentrated Cognitive-Behavior Therapy for Unmedicated Children and Adolescents With Obsessive-Compulsive Disorder in Routine Clinical Care: A Randomized Controlled Trial With a 6-Month Naturalistic Follow-up. Behav Ther. 2025 Jul;56(4):799-811. doi: 10.1016/j.beth.2025.01.001. Epub 2025 Jan 13.
PubMed 40541379
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Predictors and Neural Changes Associated With Cognitive Behavior Therapy for Obssesive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT04042038
- Acronym / sponsor ID
- HCB/2018/0681
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Keywords
- Obsessive compulsive disorder, Intensive cognitive-behavioral therapy, Neuroimaging, Response prediction, Response mechanisms, Functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de BellvitgeUniversity, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer, FIDMAG Germanes Hospitalàries
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 1 Aug 2019 (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.
The goals of the project are 1) to understand what are the neural mechanisms involved in the psychological treatment of obsessive-compulsive disorder (OCD) in children/adolescents and adults, 2) to assess potential differences in the neural mechanisms involved in the psychological treatment of OCD between children/adolescents and adults, and 3) to assess the effectiveness of intensive CBT for children/adolescents and adults with OCD.
Detailed description
Obsessive-compulsive disorder (OCD) is a frequent and disabling disorder. Cognitive-behavior therapy (CBT) is the best treatment option available for OCD, although it achieves optimum results in less than half of the patients. The investigators will investigate the main neural circuits that predict CBT outcome in OCD and the neural changes associated with CBT in two separate randomized controlled trials (RCTs), one in an adult sample and another in a pediatric sample. In this two RCTs, OCD participants will be randomized to either intensive CBT (20 sessions in 1 month) by a experienced clinician or a waiting-list control (WLC) and will be assessed (by a blind assessor) and scanned before and after CBT. Patients will be offered CBT if they have been randomized to the WLC. At baseline, the investigators will also compare OCD patients with a group of healthy controls (HC). Secondary goals of the project include 1) assessing potential differences between children/adolescents and adults in the neural mechanisms involved in CBT for OCD; 2) assess the effectiveness of intensive CBT for children/adolescents and adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two separate (but methodologically identical) RCTs will be conducted, one in a sample of children/adolescents with OCD (study 1) and another in a sample of adults with OCD (study 2). Within each study, one group of age and gender-matched healthy controls will also serve as a comparison group at baseline (clinical and neuroimaging assessment). Within each study, after baseline assessment, OCD participants will be randomized to either intensive CBT or waiting list for one month. Then, OCD participants will be assessed again (clinical and neuroimaging assessment).
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Cognitive-behavior therapy (psychological treatment)Intensive CBT (20 sessions in 1 month) |
| Waiting-list | No intervention | –Waiting-list |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Principal diagnosis of OCD;
- Y-BOCS or CYBOCS ≥ 16).
- No current psychotropic medication (except benzodiacepines for sleep). 4 ) Age between 8 and 17 years (Study 1) and between 18 and 60 years (Study 2).
Key exclusion criteria (6 listed)
- Current major depression or current/past psychosis, bipolar disorder or substance abuse.
- Developmental disorders (including autistic spectrum disorders).
- To be pregnant or during breastfeeding
- Current CBT; nt.
- Any severe medical disorder ;
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 |
|---|---|---|
| Cognitive-behavior therapy (psychological treatment)Participants will receive up to 20 hours of manualized and structured CBT based on exposure and response prevention by experienced clinicians | Behavioural | CBT |
Primary outcome
Yale-Brown Obsessive-Compulsive Scale
Time frame: Change from baseline to post-treatment (1 month)
The Yale-Brown Obsessive-Compulsive Scale evaluates the severity of Obsessive Compulsive Disorder symptoms in adults. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms) (total range, 0 to 40), with separate subtotals for severity of obsessions and compulsions.
Children´s Yale-Brown Obsessive-Compulsive Scale
Time frame: Change from baseline to post-treatment (1 month)
The Children´s Yale-Brown Obsessive-Compulsive Scale evaluates the severity of Obsessive Compulsive Disorder symptoms in children/adolescents. The severity of the obsessions is rated on five Severity Items for Obsessions. Each of these five items is rated on a 5-point, ordinal scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme. These values are anchored by a description for each score. The Obsessions Severity Score is obtained by adding the scores for items 1 through 5 (range = 0 to 20). There are five comparable Severity Items for Compulsions (items 6 through 10), which are also scored from 0 to 4. The Compulsions Severity Score is obtained by adding the scores of items 6 through 10 (range = 0 to 20). Summing the scores for all 10 items yields the CY-BOCS Total score (range = 0 to 40).
4 secondary outcomes
Obsessive-Compulsive Inventory-Revised
Time frame: Change from baseline to post-treatment (1 month)
Obsessive Compulsive Inventory-Child Version
Time frame: Change from baseline to post-treatment (1 month)
Children's Depression Inventory
Time frame: Change from baseline to 1 month.
Spence Children's Anxiety Scale
Time frame: Change from baseline to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 40541379Hermida-Barros L, Garcia-Delgar B, Lera-Miguel S, Forcadell E, Moreno E, Prime-Tous M, Jaurrieta N, Segu X, Vilajosana E, Soriano-Mas C, de la Cruz LF, Vieta E, Radua J, Lazaro L, Fullana MA. Concentrated Cognitive-Behavior Therapy for Unmedicated Children and Adolescents With Obsessive-Compulsive Disorder in Routine Clinical Care: A Randomized Controlled Trial With a 6-Month Naturalistic Follow-up. Behav Ther. 2025 Jul;56(4):799-811. doi: 10.1016/j.beth.2025.01.001. Epub 2025 Jan 13.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavior therapy (psychological treatment) in people with Obsessive-Compulsive Disorder (OCD), run by Institut d'Investigació Biomèdica de Bellvitge at 3 sites in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carles Soriano-Mas, PhD (+34 260 65 75 00 ext. 2889, csoriano@idibell.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive-Compulsive Scale (time frame: Change from baseline to post-treatment (1 month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042038, which also lists 1 linked publication.
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 1 Mar 2023.