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

Obsessive Compulsive Disorder (OCD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02886780
• Other study ID #: 2016/794 (REK vest)
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 2023

Study information

• Verified date: February 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: June 2023
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obsessive Compulsive Disorder (OCD)
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Concentrated exposure treatment (cET)
Psychological cognitive behavioral treatment
• Self-help

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Sorlandet Hospital HF

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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