Clinical trial NCT02398045: Developing Computerised CBT for Adults With OCD
Official title: Developing Computerised Cognitive Behavioural Therapy for Adults With Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Obsessive-compulsive Disorder
Keywords: Obsessive-compulsive disorder
cognitive behavioural therapy
computerised
Lead sponsor: Institute of Psychiatry, London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2015-03-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Y-BOCS-OCD
timeFrame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Secondary outcomes:
measure: Psychiatric Diagnostic Screening Questionnaire
timeFrame: baseline
measure: DSM-IV OCD SCID
timeFrame: baseline
measure: Patient Health Questionnaire
timeFrame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
measure: Generalised anxiety disorder assessment
timeFrame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
measure: Work and social adjustment scale
timeFrame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
measure: Expectation for treatment success and credibility
timeFrame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
measure: demographic variables
timeFrame: baseline
measure: Obsessive-compulsive inventory
timeFrame: baseline, week 3, week 4 or week 5 after baseline, 12 weeks, 1 month follow-up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Centre for Anxiety Disorders and Trauma
city: London
country: United Kingdom
facility: South London and Maudsley NHS Trust
Study officials:
affiliation: Institute of Psychiatry
name: David Veale, MRCPsych
role: PRINCIPAL_INVESTIGATOR
References: