Concentrated Exposure Treatment (cET) for for Obsessive Compulsive Disorder

Study Overview
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Brief Summary
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Obsessive Compulsive Disorder (OCD) often becomes chronic if not treated. Exposure and response prevention (ERP) is recommended psychological treatment. The OCD-team at Haukeland University hospital has developed a concentrated 4-day treatment format which has been evaluated as part of standard care. Next step in the methodological development is to conduct a randomized controlled trial where the 4-day format is compared to self-help and waiting list. The study will be conducted at Solvang DPS, Sørlandet Hospital. Participants (16 in each group) are ordinary patients (>18 yrs) entitled to care in the specialist health care.

Official Title
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Concentrated Exposure Treatment (cET) for Obsessive Compulsive Disorder (OCD). A Randomized Controlled Trial (RCT)

Conditions
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Obsessive Compulsive Disorder (OCD)

Intervention / Treatment
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* Behavioral: Concentrated exposure treatment (cET)
* Behavioral: Self-help


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OCD-patients referred to the OCD-team at Sørlandet Sykehus, Solvang DPS will be included. Inclusion criteria Outpatients ≥ 18 years of age Fulfilling diagnostic criteria of OCD according to the DSM-5 Y-BOCS ≥ 16 Fluent in Norwegian Signed informed consent Exclusion Criteria: OCD symptoms primarily associated with hoarding Ongoing substance abuse/dependence Bipolar disorder or psychosis Ongoing suicidal ideation Mental Retardation, based on previous medical history If using antidepressants: Not on stable dosage 4 weeks before the intervention Unwilling to remain on stable dosage during the four intervention days Unwilling to refrain from anxiety reducing substances, such as anxiolytics (e.g. benzodiazepines) and alcohol during the two days of exposure. Patients living > 1.5 hour drive by car/ train from the treatment location. Patients with a BMI-index considered too low for participation in psychological treatment Patients with a full course of prior CBT for OCD.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concentrated Exposure Treatment (cET)<br>Please refer to:Havnen, A., Hansen, B., Öst, L.-G. & Kvale, G. Concentrated ERP delivered in a group setting: An effectiveness study. Journal of Obsessive Compulsive and Related Disorders 3, 319-324 (2014) | Behavioral: Concentrated exposure treatment (cET)<br>* Psychological cognitive behavioral treatment<br>|
| Active Comparator: Self-help<br>The self-help condition (SH): Foa, E.B. & Kozak, M.J. Mastery of obsessive-compulsive disorder: Client workbook, (Graywind Publications, New York, 1997). | Behavioral: Self-help<br> <br> |
| No Intervention: Wait list<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Y-BOCS from pre cET-treatment to post treatment/ waiting list/ self-help | Y-BOCS changes will for all conditions be calculated by two approaches which will be compared. | Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up | 
| Changes i OCD diagnostic status (DSM-5) as measured by SCID |  | Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being | The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) will be administered to assess mental well-being. This scale has 14 items covering different aspects of mental health related to mental well-being. | Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up | 
| Work and social adjustment | The Work and Social Adjustment Scale (W & SAS) is a short questionnaire measuring work and social adjustment. | Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up | 
| Generalized anxiety | Generalized Anxiety Disorder Assessment 7 (GAD-7) is a brief 7-item self-report measure for generalized anxiety symptoms. Although developed for measuring severity of generalized anxiety disorder, the GAD-7 measures severity of general anxiety symptoms common to several anxiety disorders | Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up | 
| Depression | Patient Health Questionnaire, (PHQ-9) is a 9-item self-report questionnaire measuring level of depressive symptoms. Items are scored on a scale from 0 (not at all) to 3 (nearly every day). | Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up | 
| Insomnia | The Bergen Insomnia Scale (BIS) will be used to screen for sleep disturbances. The scale has six items covering different aspects of sleep disturbances the past 4 weeks | Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, six months follow up | 
| Client satisfaction | Client Satisfaction Questionnaire (CSQ-8) is an eight-item self-report form where patients report their level of satisfaction with the treatment they have undergone. | 1 week post Concentrated Exposure Treatment |