Obsessive Compulsive Disorder (OCD)NCT02216981
Examining the Feasibility and Acceptability of Good Quality Intensive CBT for OCD and Good Quality Weekly CBT for OCD
A study testing Cognitive Behavioural Therapy (CBT) in people with Obsessive Compulsive Disorder (OCD), run by University of Bath at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- Cognitive Behavioural Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Centre for Specialist Psychological Treatments of Anxiety and Related Problems (CSPTARP)
Bath, Bath, BA2 7AY
Centre for Anxiety Disorders and Trauma (CADAT)
London, Denmark Hill, SE5 8AZ
About this study
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).
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).
Read the 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.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- Cognitive Behavioural Therapy (CBT)
- Keywords
- Obsessive Compulsive Disorder (OCD), Cognitive Behavioural Therapy (CBT), Intensive therapy, Intensive treatment, Treatment Resistant
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy (CBT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, Avon and Wiltshire Mental Health Partnership NHS Trust
- Responsible party
- Principal investigator, Josie Millar, University of Bath
- Investigators
- Josie FA Millar, Principal investigator, University of BathPaul M Salkovskis, Study director, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216981
- Sponsor's protocol ID
- MILSALK1
- Status last verified
- Oct 2016
- First submitted
- 8 Aug 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT02216981
- Acronym / sponsor ID
- MILSALK1
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Obsessive Compulsive Disorder (OCD), Cognitive Behavioural Therapy (CBT), Intensive therapy, Intensive treatment, Treatment Resistant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, Avon and Wiltshire Mental Health Partnership NHS Trust
- Study start
- Aug 2014
- Primary completion
- Dec 2017 (estimated)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive Cognitive Behavioural Therapy | Experimental | Behavioral: Cognitive Behavioural Therapy (CBT)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) |
| Weekly Cognitive Behavioural Therapy | Active comparator | Behavioral: Cognitive Behavioural Therapy (CBT)Weekly CBT (an average of 12-18 hours of CBT delivered in 60-90 minute sessions on a weekly basis) |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) | Behavioural | Intensive Cognitive Behavioural Therapy, Weekly Cognitive Behavioural Therapy |
Primary outcome
Yale- Brown Obsessive Compulsive Scale (Y-BOCS) & Obsessive Compulsive Inventory
Time frame: 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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
Related trials for Obsessive Compulsive Disorder (OCD)
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josie FA Millar principal investigator
University of Bath
Paul M Salkovskis study director
University of Bath
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy (CBT) in people with Obsessive Compulsive Disorder (OCD), run by University of Bath at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale- Brown Obsessive Compulsive Scale (Y-BOCS) & Obsessive Compulsive Inventory (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.