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

ISRCTN	ISRCTN52684820
DOI	https://doi.org/10.1186/ISRCTN52684820
Secondary identifying numbers	15996

Submission date: 30/01/2014
Registration date: 30/01/2014
Last edited: 11/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Clara Strauss
Scientific

Psychology Department
Guildford
GU2 7XH
United Kingdom

Email	C.Strauss@surrey.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	Mindfulness-based behaviour therapy for OCD: a pilot RCT
Study objectives	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(s)	13/LO/1768
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/02/2014
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 40; UK Sample Size: 40
Key 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
Key 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).
Date of first enrolment	01/02/2014
Date of final enrolment	31/12/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Surrey

Guildford
GU2 7XH
United Kingdom

Sponsor information

Sussex Partnership NHS Foundation Trust (UK)
Hospital/treatment centre

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

"ROR"	https://ror.org/05fmrjg27

Funders

Funder type

Government

National Institute for Health Research: Research for Patient Benefit (RfPB)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	16/04/2015		Yes	No
Results article	results	01/06/2018		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

11/01/2019: Publication reference added.