NCT06262464

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

February 8, 2024

Last Update Submit

April 16, 2025

Conditions

Obsessive-Compulsive Disorder

Keywords

RiskPrevention

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    Baseline and Week 2

Secondary Outcomes (4)

  • Change from baseline in experiential avoidance on the EAQ after the intervention

    Baseline and Week 2

  • Change from baseline in cognitive distortions on the OBQ-44 after the intervention

    Baseline and Week 2

  • Change from baseline in uncertainty intolerance on the IUS after the intervention

    Baseline and Week 2

  • Change from baseline in resilience on the RSA after the intervention

    Baseline and Week 2

Other Outcomes (3)

  • Change from baseline in life quality on the WHOQOL-BREF after the intervention

    Baseline and Week 2

  • Change from baseline in irrationality on the ATQ after the intervention

    Baseline and Week 2

  • Change from baseline in global health on the GHQ-12 after the intervention

    Baseline and Week 2

Study Arms (2)

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.

Behavioral: Prevention

Control

NO INTERVENTION

Treatment as Usual

Interventions

PreventionBEHAVIORAL

A cognitive-behavioural prevention programme.

Prevention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- age over 18

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy

Cluj-Napoca, Romania, 400015, Romania

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38724961DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Roxana Cardoș, PhD

    Babeș-Bolyai University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roxana Cardoș, PhD

CONTACT

0040751477323roxanaoltean@psychology.ro

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

February 9, 2024

Primary Completion

July 31, 2025

Study Completion

December 31, 2025

Last Updated

April 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The documents will be shared in March 2024

Locations

RO(1)