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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obsessive Compulsive Disorder (OCD)
• Intervention / Treatment: Behavioral: Concentrated exposure treatment (cET); Behavioral: Self-help

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait list
Experimental: 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)	Behavioral: Concentrated exposure treatment (cET); Psychological cognitive behavioral treatment
Active Comparator: 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).	Behavioral: Self-help

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Sorlandet Hospital HF
• Investigators: Principal Investigator: Gerd Kvale, PhD, Haukeland UH; Study Chair: Gunvor Launes, MD, Sorlandet Hospital HF

Publications and helpful links

General Publications

• Launes G, Hagen K, Sunde T, Ost LG, Klovning I, Laukvik IL, Himle JA, Solem S, Hystad SW, Hansen B, Kvale G. A Randomized Controlled Trial of Concentrated ERP, Self-Help and Waiting List for Obsessive- Compulsive Disorder: The Bergen 4-Day Treatment. Front Psychol. 2019 Nov 15;10:2500. doi: 10.3389/fpsyg.2019.02500. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2016/794 (REK vest)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided