Condition category
Mental and Behavioural Disorders
Date applied
30/01/2014
Date assigned
30/01/2014
Last edited
14/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Clara Strauss

ORCID ID

Contact details

Psychology Department
Guildford
GU2 7XH
United Kingdom
-
C.Strauss@surrey.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15996

Study information

Scientific title

A comparison to two types of group behaviour therapy for obsessive compulsive disorder: A pilot randomised controlled trial of behaviour therapy and mindfulness-based behaviour therapy for OCD

Acronym

Mindfulness-based behaviour therapy for OCD: a pilot RCT

Study hypothesis

Obsessive compulsive disorder (OCD) affects up to one million adults in the UK (NICE, 2005). People diagnosed with OCD experience unwanted obsessive thoughts and engage in compulsive behaviours. Exposure and response prevention (ERP) is a behaviour therapy and it is the psychological therapy with the strongest evidence for effectiveness. However, only 60% of people benefit from ERP. Many people do not find ERP acceptable, with about 25% of people starting ERP dropping out.

Mindfulness-based interventions (MBIs) teach people to notice unpleasant thoughts and feelings without reacting unhelpfully. Although effective for depression, psychosis and a range of anxiety disorders, there is very little research on the effectiveness of MBIs for OCD, although the research that is published shows promise.

We conducted a focus group with six people diagnosed with OCD and who had experience of ERP and MBI. We had intended to compare MBI to ERP, however participants advised us to combine ERP with MBI. They suggested that effectiveness might be based by combining the two together. We have followed their advice in this study.

We intend to compare ‘standard ERP group behaviour therapy’ (BT) to ‘mindfulness-based ERP group behaviour therapy’ (MBBT) to see if mindfulness practice improves ERP outcomes and reduces drop-out. Before we can answer this question in a fully-sized trial we first need to conduct a pilot study. This pilot study is a small version of the fully-sized trial. It will tell us: (a) the approximate difference in outcome between BT and MBBT, (b) how easily we can recruit to the study, and (c) how many people drop out. This information will allow us to know how many participants we need for the full trial, how long recruitment will take and how to reduce drop-out rates. Once we have this information we will apply for funding for the full trial.

Ethics approval

13/LO/1768

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Personality disorder; Disease: Personality disorders

Intervention

Behaviour Therapy: A 10 session exposure and response prevention for OCD group intervention (maximum 10 participants per group). Each session will run for two hours.
Mindfulness Behaviour Therapy: A 10 session mindfulness-enhanced exposure and response prevention for OCD group intervention (maximum 10 participants per group). Each session will run for two hours. Mindfulness practice and discussion will be added to the standard ERP protocol.
Follow Up Length: 6 month(s); Study Entry : Registration only

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Yale-Brown Obsessive Compulsive Scale - Second Edition (Y-BOCS-II; Goodman et al, 2006).; Timepoint(s): Baseline, post-therapy (10 weeks post-baseline) and 6-months post-therapy

Secondary outcome measures

1. Beck Depression Inventory - second edition (BDI-II; Beck et al, 1996)
2. Change Interview (Elliott et al, 2001).; Timepoint(s): Post-therapy only
3. Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF; Bohlmeijer et al, 2011)
4. Mini Neuropsychiatric Interview 6.0.0; Timepoint(s): Baseline, post-intervention and six months post-therapy
5. Obsessional Beliefs Questionnaire - Revised - OBQ-44; Timepoint(s): Baseline, post-therapy and six months post-therapy
6. Short Warwick-Edinburgh Mental Well-Being Scale (2007); Timepoint(s): Baseline, post-therapy and 6-months post-therapy
7. Therapy attrition; Timepoint(s): Percentage of participants who complete their intervention will be recorded as a primary outcome

Overall trial start date

01/02/2014

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Meet diagnostic criteria for OCD (MINI 6.0.0 interview)
2. Have been stable on psychiatric medication for at least three months prior to the consent meeting, or not taking psychiatric medication for at least three months prior to the consent meeting
3. Have no plans for changes to psychiatric medication during the course of the study
4. Have not received psychological therapy in the past three months or to have any plans for psychological therapy during the course of the study
5. Be aged over 18 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant exclusion criteria

Exclusion criteria will be that participants will not have an identified organic cause for their OCD symptoms or a diagnosed learning disability. This will be ascertained through the care team. People will be excluded if they meet diagnostic criteria, based on the MINI interview, for; post-traumatic stress disorder, anorexia nervosa, an autistic spectrum disorder or a psychotic disorder.

To reflect the reality of mental health services and the co-morbidity of OCD with other anxiety disorders and with depressive disorders (NICE, 2005), co-morbidity with these conditions will not be an exclusion criterion. The exception to this is that people meeting diagnostic criteria for PTSD will be excluded given some concerns in the MBI literature about the offering MBIs to this population. People presenting with hoarding only compulsions will be excluded from the study, given the recent move to classify hoarding as a distinct condition from OCD (Pertusa et al, 2008).

Recruitment start date

01/02/2014

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Surrey
Guildford
GU2 7XH
United Kingdom

Sponsor information

Organisation

Sussex Partnership NHS Foundation Trust (UK)

Sponsor details

Sussex Education Centre
Nevill View Hospital
Hove
BN3 7HZ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research: Research for Patient Benefit (RfPB)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25886875

Publication citations

Additional files

Editorial Notes