An OCD Prevention Programme for at Risk Adults (ØCD)

April 16, 2025 updated by: Roxana Cardos, Babes-Bolyai University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- age over 18

Exclusion Criteria:

  • clinically diagnosed OCD
  • current psychiatric/psychotherapeutic treatment
  • personality disorder diagnosis
  • suicidal ideation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prevention
6 group, online sessions over two weeks. A prevention program using cognitive and behavioral strategies to reduce OCD risk factors and related symptoms.
Behavioral: Prevention
A cognitive-behavioural prevention programme.
No Intervention: Control
Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and Week 2
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
Baseline and Week 2
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
Baseline and Week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in experiential avoidance on the EAQ after the intervention
Time Frame: Baseline and Week 2

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
Baseline and Week 2
Change from baseline in cognitive distortions on the OBQ-44 after the intervention
Time Frame: Baseline and Week 2

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
Baseline and Week 2
Change from baseline in uncertainty intolerance on the IUS after the intervention
Time Frame: Baseline and Week 2

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
Baseline and Week 2
Change from baseline in resilience on the RSA after the intervention
Time Frame: Baseline and Week 2

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
Baseline and Week 2

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in life quality on the WHOQOL-BREF after the intervention
Time Frame: Baseline and Week 2

The WHOQOL-BREF is a validated self-report instrument assessing life quality in adults.

Change = end of intervention score - baseline score
Baseline and Week 2
Change from baseline in irrationality on the ATQ after the intervention
Time Frame: Baseline and Week 2
The ABS-AV is a validated self-report instrument assessing irrationality in adults. Possible scores range from 24 to 120 Change = end of intervention score - baseline score
Baseline and Week 2
Change from baseline in global health on the GHQ-12 after the intervention
Time Frame: Baseline and Week 2

The GHQ-12 is a validated self-report instrument assessing global health in adults.

Possible scores range from 0 to 36. Change = end of intervention score - baseline score
Baseline and Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Babes-Bolyai University

Collaborators

Romanian National Authority for Scientific Research

Investigators

  • Principal Investigator: Roxana Cardoș, PhD, Babes-Bolyai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17.361/ 07.12.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

The documents will be shared in March 2024

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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