Obsessive-compulsive DisorderEarly Phase 1CCBTNCT02398045
Developing Computerised CBT for Adults With OCD
A Early Phase 1 study testing Computerised CBT for OCD in people with Obsessive-compulsive Disorder, run by Institute of Psychiatry, London at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-compulsive Disorder
- What is being tested?
- Computerised CBT for OCD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2015to Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Centre for Anxiety Disorders and Trauma
London, London, SE5 8AZ
David Veale, Consultant Psychiatrist, 442032283212, david.veale@kcl.ac.uk
David Veale, Consultant Psychiatrist
- Recruiting
South London and Maudsley NHS Trust
London, SE5 8AZ
David M Veale, 0203 228 3461, david.veale@iop.kcl.ac.uk
Nell ET Ellison, 0203 228 3212, nell.ellison@iop.kcl.ac.uk
About this study
Official title: 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.
- Conditions
- Obsessive-compulsive Disorder
- Being tested
- Computerised CBT for OCD
- Keywords
- Obsessive-compulsive disorder, cognitive behavioural therapy, computerised
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerised CBT for OCDOther
Computerised CBT for OCD
| Study group | Role | What they receive |
|---|---|---|
| Computerised CBT | Experimental | Computerised CBT for OCD Receives: Other: Computerised CBT for OCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Y-BOCS-OCD
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.
Measured: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Secondary outcomes (8)
Psychiatric Diagnostic Screening Questionnaire
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).
Measured: baseline
DSM-IV OCD SCID
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.
Measured: baseline
Patient Health Questionnaire
Measured: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Generalised anxiety disorder assessment
This is a 7 item scale asking about anxiety levels over the past 2 weeks.
Measured: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Work and social adjustment scale
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.
Measured: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Expectation for treatment success and credibility
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.
Measured: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
demographic variables
This involves questions about Age, gender, ethnicity, education, employment, relationship status and access to the internet.
Measured: baseline
Obsessive-compulsive inventory
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.
Measured: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry, London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Principal investigator, David Veale, Institute of Psychiatry, London
- Investigators
- David Veale, MRCPsych, Principal investigator, Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398045
- Sponsor's protocol ID
- CCBT-1111
- Other IDs
- 658-PAHTLZB
- Acronym
- CCBT
- Status last verified
- Feb 2016
- First submitted
- 4 Jun 2014
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Computerised Cognitive Behavioural Therapy for Adults With Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT02398045
- Acronym / sponsor ID
- CCBT / CCBT-1111
- Conditions
- Obsessive-compulsive Disorder
- Keywords
- Obsessive-compulsive disorder, cognitive behavioural therapy, computerised
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Institute of Psychiatry, LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerised CBT | Experimental | Other: Computerised CBT for OCDComputerised CBT for OCD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerised CBT for OCDComputerised CBT for OCD | Other | Computerised CBT |
Primary outcome
Change in Y-BOCS-OCD
Time frame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
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.
8 secondary outcomes
Psychiatric Diagnostic Screening Questionnaire
Time frame: baseline
DSM-IV OCD SCID
Time frame: baseline
Patient Health Questionnaire
Time frame: 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
Work and social adjustment scale
Time frame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Expectation for treatment success and credibility
Time frame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
demographic variables
Time frame: baseline
Obsessive-compulsive inventory
Time frame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Veale, MRCPsych principal investigator
Institute of Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Computerised CBT for OCD in people with Obsessive-compulsive Disorder, run by Institute of Psychiatry, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Veale, MRCPsych (02032283212, david.veale@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Y-BOCS-OCD (time frame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.