Developing Computerised CBT for Adults With OCD

NCT02398045 | Unknown Early Phase 1 DMC

• 2 other identifiers: CCBT-1111658-PAHTLZB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Obsessive-compulsive Disorder

Keywords

Obsessive-compulsive disorder; cognitive behavioural therapy; computerised

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Psychiatric Diagnostic Screening Questionnaire

  baseline

• DSM-IV OCD SCID

  baseline

• Patient Health Questionnaire

  baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up

• Generalised anxiety disorder assessment

  baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up

• Work and social adjustment scale

  baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up

Study Arms (1)

Computerised CBT

EXPERIMENTAL

Computerised CBT for OCD

Other: Computerised CBT for OCD

Interventions

Computerised CBT for OCD OTHER

Computerised CBT for OCD

Computerised CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Psychiatry, London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (2)

Centre for Anxiety Disorders and Trauma

London, London, SE5 8AZ, United Kingdom

RECRUITING

South London and Maudsley NHS Trust

London, SE5 8AZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• David Veale, MRCPsych

  Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Veale, MRCPsych

CONTACT

02032283212; david.veale@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: March 25, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 30, 2016

Record last verified: 2016-02

Locations

GB (2)