Developing Computerised CBT for Adults With OCD

Obsessive-compulsive Disorder Clinical Trial

— CCBT  

Official title:

Developing Computerised Cognitive Behavioural Therapy for Adults With Obsessive-compulsive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02398045
• Other study ID #: CCBT-1111
• Secondary ID: 658-PAHTLZB
• Status: Recruiting
• Phase: Phase 0
• First received: June 4, 2014
• Last updated: August 29, 2016
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: Institute of Psychiatry, London
• Contact: David Veale, MRCPsych
• Phone: 02032283212
• Email: david.veale[@]kcl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Institute of Psychiatry
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Other:
• Computerised CBT for OCD
Computerised CBT for OCD

Locations

Country	Name	City	State
United Kingdom	Centre for Anxiety Disorders and Trauma	London
United Kingdom	South London and Maudsley NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Psychiatry, London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up	No
Secondary	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).	baseline	No
Secondary	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.	baseline	No
Secondary	Patient Health Questionnaire		baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up	No
Secondary	Generalised anxiety disorder assessment	This is a 7 item scale asking about anxiety levels over the past 2 weeks.	baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up	No
Secondary	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.	baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up	No
Secondary	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.	baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up	No
Secondary	demographic variables	This involves questions about Age, gender, ethnicity, education, employment, relationship status and access to the internet.	baseline	No
Secondary	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.	baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up	No