Condition category
Mental and Behavioural Disorders
Date applied
05/04/2011
Date assigned
05/04/2011
Last edited
03/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Obsessive compulsive disorder (OCD) is a common problem which affects many people and rarely improves without help. Experts recommend that people with OCD receive a 'talking treatment' called cognitive behavioural therapy (CBT). However, waiting lists for this treatment can be very long. Experts also suggest that some patients might benefit from CBT provided as 'self-help' through a book or computer, with assistance from a mental health professional. We want to see if the new treatments (computerised CBT and guided self-help) work well for people with OCD. Our study will also find out if people like the treatments.

Who can participate?
Adults aged 18 and above with OCD on a waiting list for therapist-led CBT.

What does the study involve?
Our study will test two different self-help treatments for OCD. These treatments will be tested by comparing them with those on a waiting list for scheduled individual CBT. People who are happy to take part will be asked a series of questions relating to their health. They will then be randomly allocated to one of the following three treatments:
1. Computerised CBT using an online computer system called OCFighter, with help from a mental health professional, usually by phone, but can be face-to-face
2. Guided self-help, using a book which helps people use CBT, with help from a mental health professional either face-to-face or by phone
3. Waiting list for scheduled individual CBT (the currently recommended treatment route for OCD)

Both self-help treatments will be delivered over a 12-week period. Taking part in the study does not mean that you cannot have individual CBT later. You can stay on the waiting list for CBT whatever happens in the trial. Three months later, people will be asked a further set of questions to see how they are feeling. We will also do this 6 and 12 months after the start of the study. The research study will take 4 years to complete, but participants will only be involved for 12 months. We will ask some people for permission to conduct a separate interview to discuss how they found their treatment, and whether it has helped them. We will only ask about 1 in 10 patients; people can take part in the study without agreeing to this interview.

What are the possible benefits and risks of participating?
Computerised CBT and guided self-help are quite new treatments for OCD. At the moment we don’t know how well they work. It may be that people do not find these treatments helpful. People can chose to stop using them at any point during the study without having to give a reason why. There are no known side effects of either treatment. Waiting list times for scheduled individual CBT vary from area to area. If the waiting list in a local area is less than 12 weeks people may have to wait slightly longer for their scheduled CBT appointment. People will still have the opportunity to receive individual CBT after taking part in the study.

Where is the study run from?
University of Manchester (UK).

When is the study starting and how long is it expected to run for?
The study started in September 2011 and will run until August 2015.

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).

Who is the main contact?
Prof Karina Lovell
Karina.Lovell@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Karina Lovell

ORCID ID

Contact details

University of Manchester
School of Nursing
Midwifery & Social Work
Room 6.322A
Jean McFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 7853
Karina.Lovell@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 09/81/01

Study information

Scientific title

Obsessive Compulsive Treatment Efficacy Trial (OCTET)

Acronym

OCTET

Study hypothesis

1. Identify and confirm estimated recruitment rates for an obsessive compulsive disorder (OCD) treatment trial via an internal pilot phase aimed at evaluating recruitment rates and primary outcome point
2. Proceed seamlessly to a full RCT (if recruitment is successful in the pilot phase) to determine:
2.1. The clinical and cost-effectiveness of two self-managed CBT interventions (cCBT and bibliotherapy) compared to a CBT waiting list in the management of OCD patients in the short term at 3- and 6-month follow-up
2.2. The clinical and cost-effectiveness of self-managed therapies plus conventional CBT compared to waiting list plus conventional CBT at 12-month follow-up
3. Determine patient compliance and patient and health professional acceptability of the two self-managed therapy packages (cCBT & GSH)

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/098101
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/54699/PRO-09-81-01.pdf

Ethics approval

NRES Committee North West - Lancaster; 24/05/2011, ref: 11/NW/0276

Study design

Randomised controlled trial

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

Obsessive compulsive disorder

Intervention

1. Computer-aided cognitive based therapy (cCBT) package (OC Fighter) over 12 weeks
2. Supported by six, 10-minute brief scheduled telephone calls, face to face or email contact (depending on patient preference) from a mental health professional (total direct clinical input 60 minutes)
3. Bibliotherapy (Guided Self-Help) will consist of a self-help book 'Overcoming OCD: a workbook' written by Karina Lovell
4. Participants will receive weekly guidance from a mental health professional for an initial session of 60 minutes (either face to face or telephone dependent on patient preference)
5. This is followed by up to 10 brief (30 minute) scheduled telephone, email or face to face (dependent on patient preference) sessions over a 12-week period (total direct clinical input: 6 hours).
6. Comparator - patients on a waiting list for CBT

Updated 17/09/2014: Recruitment is now complete.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Yale-Brown Obsessive Compulsive Scale (Y BOCS) checklist

Secondary outcome measures

1. Self-reported health-related quality of life (SF-36)
2. Self-reported OCD symptoms (YBOCs self-rated)
3. Generic mental health (CORE-OM)
4. Depression (PHQ9)
5. Anxiety (GAD-7)
6. Functioning (WSA)
7. Health-related quality of life (EQ5D)
8. Employment status (IAPT Employment Status questions A13 –A15)
9. Patient satisfaction (CSQ) and acceptability (qualitative interviews)
10. Percentage of patients not improved or partially improved requiring more intensive CBT

Added 17/09/2014:
11. Adult Service Use Schedule (AD-SUS) – self complete and interview

Overall trial start date

01/09/2011

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 17/09/2014:
1. Adults aged 18 and above meeting Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for obsessive compulsive disorder (assessed using six OCD questions from the Mini-International Neuropsychiatric Interview [M.I.N.I.])
2. Scoring 16 or over on the Yale Brown Obsessive Compulsive Checklist (YBOCS)
3. On a waiting list for therapist-led cognitive behavioral therapy (CBT) in either primary or secondary mental health care settings
4. Able to read English at a level of 11 years and above

Previous inclusion criteria:
1. Adults aged 18 and above meeting Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for obsessive compulsive disorder (assessed using the Structured Clinical Interview for DSM-IV [SCID-IV])
2. Scoring 16 or over on the Yale Brown Obsessive Compulsive Checklist (YBOCS)
3. On a waiting list for therapist-led cognitive behavioral therapy (CBT) in either primary or secondary mental health care settings
4. Able to read English at a level of 11 years and above

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

432

Participant exclusion criteria

Current exclusion criteria as of 17/09/2014:
1. Participants who are actively suicidal
2. Patients with organic brain disease
3. Those who are experiencing psychosis
4. Those who have a diagnosis (DSM IV) criteria of drug or alcohol misuse
5. Patients who are currently receiving a psychological treatment for OCD
6. Those who have literacy or language difficulties to an extent which would preclude them from reading written or web-based materials or conversing with a health professional


Previous exclusion criteria:
1. Participants who are actively suicidal
2. Patients with organic brain disease
3. Those who are experiencing psychosis
4. Those who have a diagnosis (DSM IV) criteria of drug or alcohol misuse
5. Patients who are currently receiving a psychological treatment for OCD
6. Patients who have received CBT for OCD in the last 6 months
7. Those who have literacy or language difficulties to an extent which would preclude them from reading written or web-based materials or conversing with a health professional
8. Patients who have been prescribed or changed to an alternative anti-depressant in the 12 weeks prior to assessment will be excluded. These patients will be offered a further assessment following 12 weeks of stable medication if there are no plans to increase the medication

Recruitment start date

01/02/2012

Recruitment end date

01/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Research & Development Office
c/o Nalin Thakker
2nd Floor
Christie Building
University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25011730

Publication citations

  1. Protocol

    Gellatly J, Bower P, McMillan D, Roberts C, Byford S, Bee P, Gilbody S, Arundel C, Hardy G, Barkham M, Reynolds S, Gega L, Mottram P, Lidbetter N, Pedley R, Peckham E, Connell J, Molle J, O'Leary N, Lovell K, Obsessive Compulsive Treatment Efficacy Trial (OCTET) comparing the clinical and cost effectiveness of self-managed therapies: study protocol for a randomised controlled trial., Trials, 2014, 15, 278, doi: 10.1186/1745-6215-15-278.

Additional files

Editorial Notes