Examining the Feasibility and Acceptability of Good Quality Intensive CBT for OCD and Good Quality Weekly CBT for OCD

Obsessive Compulsive Disorder (OCD) Clinical Trial

Official title:

A Pilot Randomised Controlled Trial to Assess the Feasibility of Cognitive Behavioural Therapy (CBT) Delivered in Time-Intensive and Weekly Treatment Formats for Treatment Resistant Obsessive Compulsive Disorder (OCD).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02216981
• Other study ID #: MILSALK1
• Status: Active, not recruiting
• Phase: N/A
• First received: August 8, 2014
• Last updated: October 25, 2016
• Start date: August 2014

Study information

• Verified date: October 2016
• Source: University of Bath
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine how feasible and acceptable it is to deliver a talking treatment called Cognitive Behavioural Therapy (CBT) in two different formats for people who have had treatment for OCD in the past but it didn't work out for them.

The two different treatment formats are CBT delivered on a weekly basis (which is approximately 12-18 hours of therapy delivered weekly for 60-90 minutes each session, followed by 1-3 monthly follow up sessions as needed) and CBT offered in an intensive format (which is having approximately 12-18 hours of therapy all in a 3-week period, followed by 1-3 monthly follow up sessions as needed).

Description:

The main aim of this study is to assess the feasibility and acceptability of Intensive CBT for treatment resistant OCD when participants are randomized to this format.

This study aims to establish an estimate of the relative efficacy of both Intensive and Weekly CBT when compared individually to wait list, for participants with a diagnosis of OCD, who have previously not responded to CBT.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary diagnosis of OCD (as confirmed by the administration of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th ed.) (DSM-IV) (SCID-I) .

• Participant identifies their main problem as OCD.

• Participant has not responded to one or more trials CBT

• Yale-Brown Obsessive Compulsive Scale (YBOCS) score of 16 or above.

• No change in psychotropic medication (if applicable) for at least 8 weeks prior to study entry. (If such a change has taken place there will be an option for the participant to take part once the medication has been stabilised).

• No intention to change psychotropic medication during the course of the trial

• Able to speak and read every day English

Exclusion Criteria:

• Severe psychiatric problem that requires separate treatment at an immediate basis and is linked to risk.

• Drug and/or alcohol dependence in last three months

• History of Psychosis or Bipolar Disorder

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Cognitive Behavioural Therapy (CBT)

Locations

Country	Name	City	State
United Kingdom	Centre for Specialist Psychological Treatments of Anxiety and Related Problems (CSPTARP)	Bath
United Kingdom	Centre for Anxiety Disorders and Trauma (CADAT)	London	Denmark Hill

Sponsors (3)

Lead Sponsor	Collaborator
University of Bath	Avon and Wiltshire Mental Health Partnership NHS Trust, South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale- Brown Obsessive Compulsive Scale (Y-BOCS) & Obsessive Compulsive Inventory	The Y-BOCS is Clinician administered and the OCI is self report, both measures assess the severity of OCD symptoms.; These measures will be used to assess change in symptom severity from base line to end of treatment and to assess if there has been a change at end of treatment, if this is maintained at 3 and 6 months following the completion of treatment.	Assessment, end of treatment (at 3 weeks for Intensive & 12-15 weeks for weekly treatment) and follow up (at 3 & 6 months post treatment completion for both groups).	No