Obsessive-Compulsive DisorderØCDNCT06262464
An OCD Prevention Programme for at Risk Adults
A study testing Prevention in people with Obsessive-Compulsive Disorder, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
The main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention. 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?
- Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- 9 Feb 2024to 31 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
- age over 18
Who cannot join
- clinically diagnosed OCD
- current psychiatric/psychotherapeutic treatment
- personality disorder diagnosis
- suicidal ideation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy
Cluj-Napoca, Romania, 400015
Roxana AI Cardos, PhD Student, 0040751477323, roxana.cardos@ubbcluj.ro
About this study
Official title: The Efficacy of an OCD Prevention Programme for at Risk Adults: a Randomized Clinical Trial
The main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention.
Read the detailed description
After being informed about the study and giving written informed consent, all eligible participants will be randomised into the experimental group or the control group (TAU). Participants will be blind to the group allocation.
The experimental group will undergo a two weeks OCD prevention program, consisting of three group sessions per week.
The control group will not receive any intervention.
Researchers will compare the experimental group to the control group to test wether the prevention programme is efficient in reducing OCD symptomatology.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Prevention
- Keywords
- Risk, Prevention
- 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.
PreventionBehavioural
A cognitive-behavioural prevention programme.
| Study group | Role | What they receive |
|---|---|---|
| Prevention | Experimental | 6 group, online sessions over two weeks. A prevention program using cognitive and behavioral strategies to reduce OCD risk factors and related symptoms. Receives: Behavioral: Prevention |
| Control | No intervention | Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in OCD symptoms on the OCI-R after the intervention
The OCI-R is a validated self-report instrument assessing OCD symptoms. Possible scores range from 0 to 72. Change = end of intervention score - baseline score
Measured: Baseline and Week 2
Change from baseline in depressive symptoms on the PHQ-9 after the intervention
The PHQ-9 is a validated self-report instrument assessing depressive symptoms. Possible scores range from 0 to 27.
Change = end of intervention score - baseline score
Measured: Baseline and Week 2
Change from baseline in anxiety symptoms on the GAD-7 after the intervention
The GAD-7 is a validated self-report instrument assessing anxiety symptoms. Possible scores range from 0 to 21.
Change = end of intervention score - baseline score
Measured: Baseline and Week 2
Secondary outcomes (4)
Change from baseline in experiential avoidance on the EAQ after the intervention
The EAQ is a validated self-report instrument assessing experiential avoidance. Possible scores range from 15 to 90.
Change = end of intervention score - baseline score
Measured: Baseline and Week 2
Change from baseline in cognitive distortions on the OBQ-44 after the intervention
The OBQ-44 is a validated self-report instrument assessing cognitive distortions in OCD. Possible scores range from 7 to 308.
Change = end of intervention score - baseline score
Measured: Baseline and Week 2
Change from baseline in uncertainty intolerance on the IUS after the intervention
The IUS is a validated self-report instrument assessing intolerance of uncertainty. Possible scores range from 27 to 135.
Change = end of intervention score - baseline score
Measured: Baseline and Week 2
Change from baseline in resilience on the RSA after the intervention
The RSA is a validated self-report instrument assessing resilience in adults. Possible scores range from 43 to 215.
Change = end of intervention score - baseline score
Measured: Baseline and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start9 Feb 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Collaborators
- Romanian National Authority for Scientific Research
- Responsible party
- Principal investigator, Roxana Cardos, Babes-Bolyai University
- Investigators
- Roxana Cardoș, PhD, Principal investigator, Babeș-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262464
- Sponsor's protocol ID
- 17.361/ 07.12.2023
- Acronym
- ØCD
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Cardos RAI, Dumitru EP, David OA. OCD: protocol for the development and evaluation of a cognitive-behavioral prevention program for obsessive-compulsive disorder. BMC Psychiatry. 2024 May 9;24(1):348. doi: 10.1186/s12888-024-05791-3.
PubMed 38724961
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of an OCD Prevention Programme for at Risk Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06262464
- Acronym / sponsor ID
- ØCD / 17.361/ 07.12.2023
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Risk, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- Romanian National Authority for Scientific Research
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Feb 2024 (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 main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention.
Detailed description
After being informed about the study and giving written informed consent, all eligible participants will be randomised into the experimental group or the control group (TAU). Participants will be blind to the group allocation.
The experimental group will undergo a two weeks OCD prevention program, consisting of three group sessions per week.
The control group will not receive any intervention.
Researchers will compare the experimental group to the control group to test wether the prevention programme is efficient in reducing OCD symptomatology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention | Experimental | Behavioral: Prevention6 group, online sessions over two weeks. A prevention program using cognitive and behavioral strategies to reduce OCD risk factors and related symptoms. |
| Control | No intervention | –Treatment as Usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age over 18
Key exclusion criteria (4 listed)
- clinically diagnosed OCD
- current psychiatric/psychotherapeutic treatment
- personality disorder diagnosis
- 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 |
|---|---|---|
| PreventionA cognitive-behavioural prevention programme. | Behavioural | Prevention |
Primary outcome
Change from baseline in OCD symptoms on the OCI-R after the intervention
Time frame: Baseline and Week 2
The OCI-R is a validated self-report instrument assessing OCD symptoms. Possible scores range from 0 to 72. Change = end of intervention score - baseline score
Change from baseline in depressive symptoms on the PHQ-9 after the intervention
Time frame: Baseline and Week 2
The PHQ-9 is a validated self-report instrument assessing depressive symptoms. Possible scores range from 0 to 27. Change = end of intervention score - baseline score
Change from baseline in anxiety symptoms on the GAD-7 after the intervention
Time frame: Baseline and Week 2
The GAD-7 is a validated self-report instrument assessing anxiety symptoms. Possible scores range from 0 to 21. Change = end of intervention score - baseline score
4 secondary outcomes
Change from baseline in experiential avoidance on the EAQ after the intervention
Time frame: Baseline and Week 2
Change from baseline in cognitive distortions on the OBQ-44 after the intervention
Time frame: Baseline and Week 2
Change from baseline in uncertainty intolerance on the IUS after the intervention
Time frame: Baseline and Week 2
Change from baseline in resilience on the RSA after the intervention
Time frame: Baseline and Week 2
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 18 Apr 2025.
- Derived from this study: PubMed 38724961Cardos RAI, Dumitru EP, David OA. OCD: protocol for the development and evaluation of a cognitive-behavioral prevention program for obsessive-compulsive disorder. BMC Psychiatry. 2024 May 9;24(1):348. doi: 10.1186/s12888-024-05791-3.
- Individual participant dataSharing planned: Yes
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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.
Roxana Cardoș, PhD principal investigator
Babeș-Bolyai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention in people with Obsessive-Compulsive Disorder, run by Babes-Bolyai University at 1 site in Romania.
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 1 inclusion and 4 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 18 Apr 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 Romania. 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 Roxana Cardoș, PhD (0040751477323, roxanaoltean@psychology.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in OCD symptoms on the OCI-R after the intervention (time frame: Baseline and Week 2). The study lists 3 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 NCT06262464, 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 18 Apr 2025; AzTrials last refreshed its copy on 29 Oct 2026.