search
Back to results

Developing Computerised CBT for Adults With OCD (CCBT)

Primary Purpose

Obsessive-compulsive Disorder

Status
Unknown status
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Computerised CBT for OCD
Sponsored by
Institute of Psychiatry, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-compulsive Disorder focused on measuring Obsessive-compulsive disorder, cognitive behavioural therapy, computerised

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Anxiety Disorders and TraumaRecruiting
  • South London and Maudsley NHS TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computerised CBT

Arm Description

Computerised CBT for OCD

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
Patient Health Questionnaire
Generalised anxiety disorder assessment
This is a 7 item scale asking about anxiety levels over the past 2 weeks.
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.
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.
demographic variables
This involves questions about Age, gender, ethnicity, education, employment, relationship status and access to the internet.
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.

Full Information

First Posted
June 4, 2014
Last Updated
August 29, 2016
Sponsor
Institute of Psychiatry, London
Collaborators
South London and Maudsley NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT02398045
Brief Title
Developing Computerised CBT for Adults With OCD
Acronym
CCBT
Official Title
Developing Computerised Cognitive Behavioural Therapy for Adults With Obsessive-compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Psychiatry, London
Collaborators
South London and Maudsley NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorder
Keywords
Obsessive-compulsive disorder, cognitive behavioural therapy, computerised

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computerised CBT
Arm Type
Experimental
Arm Description
Computerised CBT for OCD
Intervention Type
Other
Intervention Name(s)
Computerised CBT for OCD
Intervention Description
Computerised CBT for OCD
Primary Outcome Measure Information:
Title
Change in Y-BOCS-OCD
Description
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.
Time Frame
baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Secondary Outcome Measure Information:
Title
Psychiatric Diagnostic Screening Questionnaire
Description
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).
Time Frame
baseline
Title
DSM-IV OCD SCID
Description
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.
Time Frame
baseline
Title
Patient Health Questionnaire
Time Frame
baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Title
Generalised anxiety disorder assessment
Description
This is a 7 item scale asking about anxiety levels over the past 2 weeks.
Time Frame
baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Title
Work and social adjustment scale
Description
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.
Time Frame
baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Title
Expectation for treatment success and credibility
Description
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.
Time Frame
baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Title
demographic variables
Description
This involves questions about Age, gender, ethnicity, education, employment, relationship status and access to the internet.
Time Frame
baseline
Title
Obsessive-compulsive inventory
Description
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.
Time Frame
baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Veale, MRCPsych
Phone
02032283212
Email
david.veale@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Veale, MRCPsych
Organizational Affiliation
Institute of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Anxiety Disorders and Trauma
City
London
ZIP/Postal Code
SE5 8AZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Veale, Consultant Psychiatrist
Phone
442032283212
Email
david.veale@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
David Veale, Consultant Psychiatrist
Facility Name
South London and Maudsley NHS Trust
City
London
ZIP/Postal Code
SE5 8AZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David M Veale
Phone
0203 228 3461
Email
david.veale@iop.kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Nell ET Ellison
Phone
0203 228 3212
Email
nell.ellison@iop.kcl.ac.uk

12. IPD Sharing Statement

Learn more about this trial

Developing Computerised CBT for Adults With OCD

We'll reach out to this number within 24 hrs