- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02398045
Developing Computerised CBT for Adults With OCD (CCBT)
August 29, 2016 updated by: David Veale, Institute of Psychiatry, London
Developing Computerised Cognitive Behavioural Therapy for Adults With Obsessive-compulsive Disorder
The study aims to pilot a new computerised cognitive behavioural therapy programme for a small case series of adults with obsessive-compulsive disorder.
The investigators hypothesise that the findings will demonstrate improvements in symptomatology following the programme.
The programme will have longer-term aims of being rolled out over a number of IAPT services within the NHS, reducing waiting lists and increasing therapist time.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: David Veale, MRCPsych
- Phone Number: 02032283212
- Email: david.veale@kcl.ac.uk
Study Locations
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London, United Kingdom, SE5 8AZ
- Recruiting
- Centre for Anxiety Disorders and Trauma
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Contact:
- David Veale, Consultant Psychiatrist
- Phone Number: 442032283212
- Email: david.veale@kcl.ac.uk
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Principal Investigator:
- David Veale, Consultant Psychiatrist
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London, United Kingdom, SE5 8AZ
- Recruiting
- South London and Maudsley NHS Trust
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Contact:
- David M Veale
- Phone Number: 0203 228 3461
- Email: david.veale@iop.kcl.ac.uk
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Contact:
- Nell ET Ellison
- Phone Number: 0203 228 3212
- Email: nell.ellison@iop.kcl.ac.uk
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults aged 18 or over with OCD as defined by DSM-IV who are seeking CBT.
- The patient describes their OCD as their main problem and scores between 14 and 30 on the YBOCS (Goodman et al, 1989). A score above 30 is in the severe range and indicates that the CBT should probably be therapist delivered.
- Able to use self-help materials in English and answer written questionnaires.
- Able to access the internet (either at home or in a public library or drop in centre or at the clinic).
- Have a current episode of OCD of more than 6 months in duration.
Exclusion Criteria:
- Significant and complex co-morbidity (e.g. significant personality disorder, severe depression or alcohol dependence, which requires longer therapy or is more difficult to treat). Such patients are likely to be part of a Community Mental Health team or be funded by the Department of Health's National Specialist Commissioning Team scheme for severe treatment refectory OCD.
- Current active suicidal intent or severe self-neglect that requires hospitalisation.
- The patient has a primary problem of compulsive hoarding (as such patients are more complex or are more likely to be under a Community Mental Health team).
- Continuing to receive another form of psychotherapy.
- Has received CBT for OCD in the past year.
- A participant may be taking an anti-depressant for OCD but must be on a stable dose for at least 12 weeks prior to entry in the trial with no plans to alter the dose during the trial period. There must also be no plan to commence on an anti-depressant or anti-psychotic medication. (Participants excluded because of their current or planned medication may be offered a further assessment for the trial after being on a stable dose
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computerised CBT
Computerised CBT for OCD
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Computerised CBT for OCD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Y-BOCS-OCD
Time Frame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
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Yale-Brown Obsessive-Compulsive Scale for OCD.
Questions focus on obsessive thoughts participants may have along with behaviours they feel compelled to do in order to reduce their anxiety.
This outcome is expected to change (improve) from baseline throughout the trial as a result of the computerised CBT.
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baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychiatric Diagnostic Screening Questionnaire
Time Frame: baseline
|
This form asks participants about emotions, mood, thoughts, and behaviours and asks patients to describe how they've been acting, feeling or thinking.
Questions refer specifically to either the last 2 weeks or the last 6 months (and specify which when necessary).
|
baseline
|
DSM-IV OCD SCID
Time Frame: baseline
|
This is used to check that participants meet the DSM-IV diagnosis for Obsessive-Compulsive Disorder and covers a range of questions from any previous treatment received to alcohol and drug consumption.
|
baseline
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Patient Health Questionnaire
Time Frame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
|
baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
|
|
Generalised anxiety disorder assessment
Time Frame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
|
This is a 7 item scale asking about anxiety levels over the past 2 weeks.
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baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
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Work and social adjustment scale
Time Frame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
|
This scale has 5 questions, each of which is answered using a 9 point likert scale.
It focuses on work, home management, social and private leisure activities, and relationships/family.
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baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
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Expectation for treatment success and credibility
Time Frame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
|
Based on the information collected from all other measures, a therapist or clinician will make a prediction about the participants suitability for treatment using CBT, and how well (or not well) they expect the participant to respond to CBT treatment.
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baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
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demographic variables
Time Frame: baseline
|
This involves questions about Age, gender, ethnicity, education, employment, relationship status and access to the internet.
|
baseline
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Obsessive-compulsive inventory
Time Frame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
|
This measure involved 42 statements relating to distress that people may experience in their everyday lives.
Participants will answer each statement on a likert scale from 0-4 in terms of how much that experience has bothered them during the past month.
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baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Veale, MRCPsych, Institute of Psychiatry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
June 4, 2014
First Submitted That Met QC Criteria
March 19, 2015
First Posted (Estimate)
March 25, 2015
Study Record Updates
Last Update Posted (Estimate)
August 30, 2016
Last Update Submitted That Met QC Criteria
August 29, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCBT-1111
- 658-PAHTLZB (Other Grant/Funding Number: Maudsley Charity)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Computerised CBT for OCD
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University of ReadingCompleted
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New York State Psychiatric InstituteNational Institute of Mental Health (NIMH)Completed
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University Health Network, TorontoCompletedEating Disorder | PostTraumatic Stress DisorderCanada
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University of RochesterNational Institute of Nursing Research (NINR); National Institute of Neurological... and other collaboratorsCompleted
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VA Office of Research and DevelopmentActive, not recruiting
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University of California, San FranciscoCompletedDepressionUnited States