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

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).

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).

Study Overview

• Status: Unknown
• Conditions: Obsessive Compulsive Disorder (OCD)
• Intervention / Treatment: Behavioral: Cognitive Behavioural Therapy (CBT)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bath, United Kingdom, BA2 7AY
    • Centre for Specialist Psychological Treatments of Anxiety and Related Problems (CSPTARP)
  • Denmark Hill
    • London, Denmark Hill, United Kingdom, SE5 8AZ
      • Centre for Anxiety Disorders and Trauma (CADAT)

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Cognitive Behavioural Therapy; Intensive CBT (an average of 12-18 hours of CBT offered in an intensive format, delivered on 2-3 days per week over a period of 3 weeks)	Behavioral: Cognitive Behavioural Therapy (CBT)
Active Comparator: Weekly Cognitive Behavioural Therapy; Weekly CBT (an average of 12-18 hours of CBT delivered in 60-90 minute sessions on a weekly basis)	Behavioral: Cognitive Behavioural Therapy (CBT)
No Intervention: Wait list; Wait list (3 months). Participants randomized to wait list will commence treatment after 3 months, in the treatment condition to which they are re-randomized (either Intensive or Weekly CBT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: University of Bath
• Collaborators: South London and Maudsley NHS Foundation Trust; Avon and Wiltshire Mental Health Partnership NHS Trust
• Investigators: Principal Investigator: Josie FA Millar, University of Bath; Study Director: Paul M Salkovskis, University of Bath

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: August 12, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Cognitive Behavioural Therapy (CBT); Obsessive Compulsive Disorder (OCD); Intensive treatment; Intensive therapy; Treatment Resistant
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: MILSALK1