An OCD Prevention Programme for at Risk Adults

Obsessive-Compulsive Disorder Clinical Trial

— ØCD  

Official title:

The Efficacy of an OCD Prevention Programme for at Risk Adults: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262464
• Other study ID #: 17.361/ 07.12.2023
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: April 1, 2024

Study information

• Verified date: March 2024
• Source: Babes-Bolyai University
• Contact: Roxana Cardo?, PhD
• Phone: 0040751477323
• Email: roxanaoltean[@]psychology.ro
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age over 18

Exclusion Criteria:

• clinically diagnosed OCD

• current psychiatric/psychotherapeutic treatment

• personality disorder diagnosis

• suicidal ideation

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Prevention
A cognitive-behavioural prevention programme.

Locations

Country	Name	City	State
Romania	Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy	Cluj-Napoca

Sponsors (2)

Lead Sponsor	Collaborator
Babes-Bolyai University	Romanian National Authority for Scientific Research

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in life quality on the WHOQOL-BREF after the intervention	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
Other	Change from baseline in irrationality on the ATQ after the intervention	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
Other	Change from baseline in global health on the GHQ-12 after the intervention	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
Primary	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
Primary	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
Primary	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	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	Baseline and Week 2
Secondary	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	Baseline and Week 2
Secondary	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	Baseline and Week 2
Secondary	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	Baseline and Week 2