"Concentrated Exposure Treatment" (cET) for for Obsessive Compulsive Disorder

Not Applicable

• Conditions: Obsessive Compulsive Disorder (OCD)
• Interventions: Behavioral: Concentrated exposure treatment (cET); Behavioral: Self-help

• Registration Number: NCT02886780
• Lead Sponsor: Haukeland University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-31
• Study Start: 2016-09
• Study First Posted: 2016-09-01
• Primary Completion: 2018-06
• Status Verified: 2020-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concentrated Exposure Treatment (cET)	Concentrated exposure treatment (cET)	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)
Self-help	Self-help	The self-help condition (SH): Foa, E.B. \& Kozak, M.J. Mastery of obsessive-compulsive disorder: Client workbook, (Graywind Publications, New York, 1997).

Primary Outcome Measures

Name	Time	Method
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
Changes in Y-BOCS from pre cET-treatment to post treatment/ waiting list/ self-help	Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up	Y-BOCS changes will for all conditions be calculated by two approaches which will be compared.

Secondary Outcome Measures

Name	Time	Method
Well-being	Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up	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.
Generalized anxiety	Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up	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
Work and social adjustment	Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up	The Work and Social Adjustment Scale (W \& SAS) is a short questionnaire measuring work and social adjustment.
Client satisfaction	1 week post Concentrated Exposure Treatment	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.
Depression	Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up	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).
Insomnia	Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, six months follow up	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