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| Name | Class |
|---|---|
| Romanian National Authority for Scientific Research | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Treatment as Usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevention | Behavioral | A cognitive-behavioural prevention programme. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline in cognitive distortions on the OBQ-44 after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline in irrationality on the ATQ after the intervention |
Inclusion Criteria:
- age over 18
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roxana Cardoș, PhD | Contact | 0040751477323 | roxanaoltean@psychology.ro |
| Name | Affiliation | Role |
|---|---|---|
| Roxana Cardoș, PhD | Babeș-Bolyai University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy | Recruiting | Cluj-Napoca | Romania | 400015 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38724961 | Derived | 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. |
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The documents will be shared in March 2024
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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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 | 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 | 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 |
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 | 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 |
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