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

Primary Purpose

Obsessive Compulsive Disorder (OCD)

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy (CBT)
Sponsored by
University of Bath
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder (OCD) focused on measuring Obsessive Compulsive Disorder (OCD), Cognitive Behavioural Therapy (CBT), Intensive therapy, Intensive treatment, Treatment Resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Anxiety Disorders and Trauma (CADAT)
  • Centre for Specialist Psychological Treatments of Anxiety and Related Problems (CSPTARP)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Intensive Cognitive Behavioural Therapy

Weekly Cognitive Behavioural Therapy

Wait list

Arm Description

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)

Weekly CBT (an average of 12-18 hours of CBT delivered in 60-90 minute sessions on a weekly basis)

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2014
Last Updated
October 25, 2016
Sponsor
University of Bath
Collaborators
South London and Maudsley NHS Foundation Trust, Avon and Wiltshire Mental Health Partnership NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02216981
Brief Title
Examining the Feasibility and Acceptability of Good Quality Intensive CBT for OCD and Good Quality Weekly CBT for OCD
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).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bath
Collaborators
South London and Maudsley NHS Foundation Trust, Avon and Wiltshire Mental Health Partnership NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder (OCD)
Keywords
Obsessive Compulsive Disorder (OCD), Cognitive Behavioural Therapy (CBT), Intensive therapy, Intensive treatment, Treatment Resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Description
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)
Arm Title
Weekly Cognitive Behavioural Therapy
Arm Type
Active Comparator
Arm Description
Weekly CBT (an average of 12-18 hours of CBT delivered in 60-90 minute sessions on a weekly basis)
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy (CBT)
Primary Outcome Measure Information:
Title
Yale- Brown Obsessive Compulsive Scale (Y-BOCS) & Obsessive Compulsive Inventory
Description
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.
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josie FA Millar
Organizational Affiliation
University of Bath
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul M Salkovskis
Organizational Affiliation
University of Bath
Official's Role
Study Director
Facility Information:
Facility Name
Centre for Anxiety Disorders and Trauma (CADAT)
City
London
State/Province
Denmark Hill
ZIP/Postal Code
SE5 8AZ
Country
United Kingdom
Facility Name
Centre for Specialist Psychological Treatments of Anxiety and Related Problems (CSPTARP)
City
Bath
ZIP/Postal Code
BA2 7AY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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