Condition category
Mental and Behavioural Disorders
Date applied
06/09/2013
Date assigned
05/11/2013
Last edited
07/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Obsessive Compulsive Disorder (OCD) is the 4th most common mental disorder and is in the top ten most disabling illnesses described by the World Health Organization. For people struggling with OCD there is one recommended psychological treatment, Cognitive Behavioural Therapy (CBT), based on exposure and response prevention), available in NHS primary care services. Although this is generally a successful treatment, not all patients do well with this approach. The aim of this study is to investigate if Eye Movement Desensitization and Reprocessing (EMDR), a psychological therapy presently used for post traumatic stress disorder, can also be a successful treatment for OCD. We are interested in finding out how EMDR compares to CBT, and we also want to know what participants think about using EMDR as a treatment for this disorder.

Who can participate?
Anyone who has been referred to the Leeds Primary Care Mental Health and Improving Access to Psychological Therapies (IAPT) Service, has a diagnosis of OCD and is seeking treatment for this.

What does the study involve?
The participants will complete an initial diagnostic interview with the study coordinator. Then they will be randomly allocated to one or two groups: CBT or EMDR.
The participants will be asked to complete an OCD questionnaire at the beginning of every session and at 6 months follow up after the end of treatment.

What are the possible benefits and risks of participating?
Benefits - Participation in the study could help to improve participants' symptoms of OCD. There are dedicated research therapists, which means participants will receive treatment fairly quickly, since they will not be placed on the usual waiting list for psychological treatments. In addition, the results of the study will inform the future development of psychological approaches for OCD.
Risks - Participants will not be able to choose which of the two treatments they want to have. The researchers will offer them one of the treatments based on a method called ‘random allocation’. Random allocation ensures that all participants have equal chance of being offered either treatment; it is similar to making a decision by ‘tossing a coin’ because there’s an equal chance of ending up with heads or tails. This method will ensure that the total number of participants are evenly distributed across both treatments. The research questionnaires will ask participants to rate how often they have experienced some key symptoms of OCD during the previous week. This may be uncomfortable for some people as it may bring up difficult or unpleasant feelings. However, these are questions that patients are asked as part of routine treatment anyway. The only difference to routine psychological treatment is that there is one additional questionnaire used in this study.

Where is the study run from?
Leeds Primary Care Mental Health and IAPT Service.

When is the study starting and how long is it expected to run for?
The study is expected to start in November 2013 and will run for two years.

Who is funding the study?
Leeds Community Healthcare NHS Trust (UK)

Who is the main contact person?
Jaime Delgadillo
jaime.delgadillo@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jaime Delgadillo

ORCID ID

Contact details

Primary Care Mental Health Service
Reginald Centre
2nd Floor
263 Chapeltown Rd
Leeds
LS73EX
United Kingdom
+44 (0)1138434388
jaime.delgadillo@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R010

Study information

Scientific title

Feasibility randomized controlled trial comparing EMDR versus CBT in the treatment of obsessive compulsive disorder

Acronym

ECO Trial

Study hypothesis

1. To evaluate the feasibility of (a) recruiting, (b) randomising, (c) completing structured treatment protocols for EMDR and CBT as usual with OCD patients, and (d) measuring outcomes at repeated intervals.
2. We expect comparable outcomes in terms of symptom reduction (effect size), recovery rates (reliable and clinically significant improvements in OCD measure) and treatment completion rates.

Ethics approval

Leeds Bradford REC, 15/10/2013, ref: 13/YH/0338

Study design

Feasibility randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Obsessive Compulsive Disorder

Intervention

Participants will be randomly allocated to one of two treatments. Both treatments will be delivered by trained CBT and EMDR therapists.

1. CBT (based on exposure and response prevention) aims to reduce the anxiety and fear associated with OCD and to reduce the need for repetitive or ‘compulsive’ actions. First, this involves meeting with a therapist to identify the types of situations that bring up or ‘trigger’ OCD symptoms and fears. Second, it involves slowly coming into contact with your fears, allowing individuals to learn that they can successfully cope. Repeatedly facing one’s fears and learning to manage the uncomfortable feelings and thoughts associated with these fears allows the anxiety to gradually fade away.
2. EMDR is a psychological therapy that also uses the natural healing ability of your body. As with CBT, this firstly involves meeting with a therapist to identify situations that ‘trigger’ OCD symptoms and fears. Then each current trigger is dealt with using repeated eye movements from side to side, until they are no longer distressing to bring to mind. This process is then repeated with any related past memories. Once the current triggers and past related memories are no longer distressing, it is expected that the uncomfortable thoughts and feelings will fade away.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Self rated Yale-Brown Obsessive Compulsive Scale (YBOCS) questionnaire
Measured at the beginning of every treatment sessions and at 6 months follow up

Secondary outcome measures

Routine IAPT measures:
1. Obsessive-Compulsive Inventory (OCI) (for obsessive compulsive symptoms)
2. Patient Health Questionnaire (PHQ9) (for depressive symptoms)
3. Generalized Anxiety Disorder (GAD7) (for anxiety symptoms)
4. Work and Social Adjustment Scale (WSAS) (measure of general functioning and adjustment)

Overall trial start date

01/11/2013

Overall trial end date

01/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Patients have been referred or signposted to an Improving Access to Psychological Therapies (IAPT) service in Leeds and are suitable for treatment in a primary care setting on the basis of
1. Having a common mental disorder
2. Low risk of harm to self or others.
Patients must meet ICD-10 diagnostic criteria for OCD, and this is the person's primary concern or reason for seeking treatment.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 50

Participant exclusion criteria

This study is embedded in routine primary care mental health services, which specifically supports patients with common mental health problems.
1. Patients with severe mental health problems are treated in psychiatric or secondary care mental health services, are routinely referred on to secondary care and therefore will not be recruited to this trial
2. Patients who are unsuitable for treatment in a primary care setting due to acute suicidal risk.
3. Patients who meet criteria for alcohol or drug dependence (identified using a validated Severity of Dependence Scale).
4. Patients who do not currently meet diagnostic criteria for OCD as defined by the ICD-10.
5. OCD is not the person's primary concern.
6. Patients who are currently using prescribed benzodiazepines, which is a contra-indication to EMDR treatment. Potential participants using any other sedatives (e.g. opiates) will be interviewed by the study co-ordinator to determine whether the current dose may pose an obstacle to treatment (in consultation with the prescribing physician).

Recruitment start date

01/11/2013

Recruitment end date

01/11/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Mental Health Service
Leeds
LS73EX
United Kingdom

Sponsor information

Organisation

Leeds Community Healthcare NHS Trust (UK)

Sponsor details

c/o Ms Linda Dobrzanska
Stockdale House
Headingly Business Park
Victoria Road
Leeds
LS6 1PF
United Kingdom
+44 (0)113 203 3473
linda.dobrzanska@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Community Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes