Clinical trial NCT06262464: An OCD Prevention Programme for at Risk Adults
Official title: The Efficacy of an OCD Prevention Programme for at Risk Adults: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Risk
Prevention
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: Romanian National Authority for Scientific Research
First posted: 2024-02-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

- age over 18

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline in OCD symptoms on the OCI-R after the intervention
timeFrame: Baseline and Week 2
measure: Change from baseline in depressive symptoms on the PHQ-9 after the intervention
timeFrame: Baseline and Week 2
measure: Change from baseline in anxiety symptoms on the GAD-7 after the intervention
timeFrame: Baseline and Week 2
Secondary outcomes:
measure: Change from baseline in experiential avoidance on the EAQ after the intervention
timeFrame: Baseline and Week 2
measure: Change from baseline in cognitive distortions on the OBQ-44 after the intervention
timeFrame: Baseline and Week 2
measure: Change from baseline in uncertainty intolerance on the IUS after the intervention
timeFrame: Baseline and Week 2
measure: Change from baseline in resilience on the RSA after the intervention
timeFrame: Baseline and Week 2
Other outcomes:
measure: Change from baseline in life quality on the WHOQOL-BREF after the intervention
timeFrame: Baseline and Week 2
measure: Change from baseline in irrationality on the ATQ after the intervention
timeFrame: Baseline and Week 2
measure: Change from baseline in global health on the GHQ-12 after the intervention
timeFrame: Baseline and Week 2
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy
Study officials:
affiliation: Babeș-Bolyai University
name: Roxana Cardoș, PhD
role: PRINCIPAL_INVESTIGATOR
References: