NCT02216981

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

3.3 years

First QC Date

August 8, 2014

Last Update Submit

October 25, 2016

Conditions

Obsessive Compulsive Disorder (OCD)

Keywords

Obsessive Compulsive Disorder (OCD)Cognitive Behavioural Therapy (CBT)Intensive therapyIntensive treatmentTreatment Resistant

Outcome Measures

Primary Outcomes (1)

  • Yale- Brown Obsessive Compulsive Scale (Y-BOCS) & Obsessive Compulsive Inventory

    The Y-BOCS is Clinician administered and the OCI is self report, both measures assess the severity of OCD symptoms. These measures will be used to assess change in symptom severity from base line to end of treatment and to assess if there has been a change at end of treatment, if this is maintained at 3 and 6 months following the completion of treatment.

    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).

Study Arms (3)

Intensive Cognitive Behavioural Therapy

EXPERIMENTAL

Intensive CBT (an average of 12-18 hours of CBT offered in an intensive format, delivered on 2-3 days per week over a period of 3 weeks)

Behavioral: Cognitive Behavioural Therapy (CBT)

Weekly Cognitive Behavioural Therapy

ACTIVE COMPARATOR

Weekly CBT (an average of 12-18 hours of CBT delivered in 60-90 minute sessions on a weekly basis)

Behavioral: Cognitive Behavioural Therapy (CBT)

Wait list

NO INTERVENTION

Wait list (3 months). Participants randomized to wait list will commence treatment after 3 months, in the treatment condition to which they are re-randomized (either Intensive or Weekly CBT).

Interventions

Cognitive Behavioural Therapy (CBT)BEHAVIORAL
Intensive Cognitive Behavioural TherapyWeekly Cognitive Behavioural Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Specialist Psychological Treatments of Anxiety and Related Problems (CSPTARP)

Bath, Bath, BA2 7AY, United Kingdom

Location

Centre for Anxiety Disorders and Trauma (CADAT)

London, Denmark Hill, SE5 8AZ, United Kingdom

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Josie FA Millar

    University of Bath

    PRINCIPAL INVESTIGATOR

  • Paul M Salkovskis

    University of Bath

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer & Clinical Psychologist

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 15, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2017

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

GB(2)