Clinical trial NCT02216981: Examining the Feasibility and Acceptability of Good Quality Intensive CBT for OCD and Good Quality Weekly CBT for OCD
Official title: A Pilot Randomised Controlled Trial to Assess the Feasibility of Cognitive Behavioural Therapy (CBT) Delivered in Time-Intensive and Weekly Treatment Formats for Treatment Resistant Obsessive Compulsive Disorder (OCD).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obsessive Compulsive Disorder (OCD)
Keywords: Obsessive Compulsive Disorder (OCD)
Cognitive Behavioural Therapy (CBT)
Intensive therapy
Intensive treatment
Treatment Resistant
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
name: Avon and Wiltshire Mental Health Partnership NHS Trust
First posted: 2014-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine how feasible and acceptable it is to deliver a talking treatment called Cognitive Behavioural Therapy (CBT) in two different formats for people who have had treatment for OCD in the past but it didn't work out for them.

The two different treatment formats are CBT delivered on a weekly basis (which is approximately 12-18 hours of therapy delivered weekly for 60-90 minutes each session, followed by 1-3 monthly follow up sessions as needed) and CBT offered in an intensive format (which is having approximately 12-18 hours of therapy all in a 3-week period, followed by 1-3 monthly follow up sessions as needed).

Detailed description: The main aim of this study is to assess the feasibility and acceptability of Intensive CBT for treatment resistant OCD when participants are randomized to this format.

This study aims to establish an estimate of the relative efficacy of both Intensive and Weekly CBT when compared individually to wait list, for participants with a diagnosis of OCD, who have previously not responded to CBT.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of OCD (as confirmed by the administration of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th ed.) (DSM-IV) (SCID-I) .
* Participant identifies their main problem as OCD.
* Participant has not responded to one or more trials CBT
* Yale-Brown Obsessive Compulsive Scale (YBOCS) score of 16 or above.
* No change in psychotropic medication (if applicable) for at least 8 weeks prior to study entry. (If such a change has taken place there will be an option for the participant to take part once the medication has been stabilised).
* No intention to change psychotropic medication during the course of the trial
* Able to speak and read every day English

Exclusion Criteria:

* Severe psychiatric problem that requires separate treatment at an immediate basis and is linked to risk.
* Drug and/or alcohol dependence in last three months
* History of Psychosis or Bipolar Disorder

Primary outcomes:
measure: Yale- Brown Obsessive Compulsive Scale (Y-BOCS) & Obsessive Compulsive Inventory
timeFrame: Assessment, end of treatment (at 3 weeks for Intensive & 12-15 weeks for weekly treatment) and follow up (at 3 & 6 months post treatment completion for both groups).
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Centre for Anxiety Disorders and Trauma (CADAT)
state: Denmark Hill
city: Bath
country: United Kingdom
facility: Centre for Specialist Psychological Treatments of Anxiety and Related Problems (CSPTARP)
Study officials:
affiliation: University of Bath
name: Josie FA Millar
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bath
name: Paul M Salkovskis
role: STUDY_DIRECTOR
References: