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Clinical Trials/NCT02398045
NCT02398045
Unknown
Early Phase 1

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

Institute of Psychiatry, London2 sites in 1 country12 target enrollmentOctober 2015

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Obsessive-compulsive Disorder
Sponsor
Institute of Psychiatry, London
Enrollment
12
Locations
2
Primary Endpoint
Change in Y-BOCS-OCD
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
December 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Institute of Psychiatry, London
Responsible Party
Principal Investigator
Principal Investigator

David Veale

Dr

Institute of Psychiatry, London

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Work and social adjustment scale(baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up)
  • Obsessive-compulsive inventory(baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up)
  • DSM-IV OCD SCID(baseline)
  • Expectation for treatment success and credibility(baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up)
  • Psychiatric Diagnostic Screening Questionnaire(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)
  • demographic variables(baseline)

Study Sites (2)

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