Obsessive-compulsive DisorderNCT00316355
Stepped Care for Treating Obsessive-Compulsive Disorder
A study testing Traditional CBT and Stepped-Care CBT in people with Obsessive-compulsive Disorder, run by Hartford Hospital at 1 site in United States.
Trial summary
This study will determine the effectiveness and cost-effectiveness of a stepped-care treatment program for people with obsessive-compulsive disorder. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Obsessive-compulsive Disorder
- What is being tested?
- Traditional CBT and Stepped-Care CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of OCD of moderate or greater severity
- Presence of OCD symptoms for at least 1 year
Who cannot join
- History of psychotic or developmental disorder
- Uncontrolled bipolar disorder
- Serious suicide risk
- Prior history of adequate CBT, including exposure and response prevention
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Living/Hartford Hospital
Hartford, Connecticut, 06106
About this study
Official title: Stepped Care for Obsessive-Compulsive Disorder
This study will determine the effectiveness and cost-effectiveness of a stepped-care treatment program for people with obsessive-compulsive disorder.
Read the detailed description
Obsessive-Compulsive Disorder (OCD) is a chronic and debilitating anxiety disorder. People with OCD often experience recurrent unwanted thoughts, called obsessions, and repetitive behaviors, called compulsions. These thoughts and behaviors interfere with everyday life to a great extent. Currently, the most frequently used psychosocial treatment for OCD is cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP). However, although effective, this treatment approach is largely inaccessible, time-consuming, labor-intensive, and expensive. A stepped-care approach to treating OCD may be more cost-effective and therefore more accessible for many individuals. Stepped-care CBT begins with the least expensive, least intrusive, most accessible option, and works up to the most expensive option if the less intrusive treatments do not work. This study will determine the benefits and cost-effectiveness of a stepped care treatment program for OCD.
Participants in this open label study will be randomly assigned to receive CBT for 6 to 14 weeks either through the stepped-care approach or immediately upon study entry. Participants will report to the study site for treatments and assessments on a regular basis, ranging from every 2 weeks to twice a week, depending on the stage of the study and the assigned treatment group. Stepped-care CBT will begin with self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement. If ineffective, this treatment will be followed by therapist-administered EX/RP. OCD symptoms will be assessed at Week 6. Participants who have responded to treatment after 6 weeks will not receive further treatment. All others will continue for an additional 8 weeks. These participants' OCD symptoms will be assessed again at Week 14. Participants assigned to the stepped-care approach whose OCD symptoms improved initially, but relapsed without further treatment by the Week 14 evaluation will receive full-scale CBT. Outcomes will be assessed again at 1- and 3-month follow-up visits.
- Conditions
- Obsessive-compulsive Disorder
- Being tested
- Traditional CBT, Stepped-Care CBT
- Keywords
- Anxiety, Behavior therapy, Cognitive-behavioral therapy, Stepped care, Cost-effectiveness
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional CBTBehavioural
CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.
Stepped-Care CBTBehavioural
In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP).
| Study group | Role | What they receive |
|---|---|---|
| Traditional CBT | Active comparator | Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP) Receives: Behavioral: Traditional CBT |
| Stepped-Care CBT | Experimental | Stepped-care CBT Receives: Behavioral: Stepped-Care 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) Total Score
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score was used as the outcome measure. The Y-BOCS is a clinician-rated scale assessing obsession (5 items) and compulsion (5 items) symptom severity on a 0 to 4 scale. All 10 items are added for the total score, with total scores ranging from 0 to 40, and higher numbers indicating more severe symptoms.
Measured: Pretreatment, Posttreatment, and 3-month follow-up
Treatment-related Total Cost Estimates
total estimated costs calculated based upon the fixed-dose schedule
Measured: Posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-compulsive DisorderStudies 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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Tolin, Hartford Hospital
- Investigators
- David F. Tolin, PhD, Principal investigator, Institute of Living/Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316355
- Sponsor's protocol ID
- R34MH071464
- Other IDs
- R34MH071464
- Status last verified
- Jan 2018
- First submitted
- 18 Apr 2006
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tolin, D.F., Diefenbach, G.J., Maltby, N., & Hannan, S. (2005). Stepped care for obsessive-compulsive disorder: A pilot study. Cognitive and Behavioral Practice, 12, 403-414.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care for Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00316355
- Acronym / sponsor ID
- R34MH071464
- Conditions
- Obsessive-compulsive Disorder
- Keywords
- Anxiety, Behavior therapy, Cognitive-behavioral therapy, Stepped care, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Apr 2006 (estimated)
- Results
- Posted 6 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effectiveness and cost-effectiveness of a stepped-care treatment program for people with obsessive-compulsive disorder.
Detailed description
Obsessive-Compulsive Disorder (OCD) is a chronic and debilitating anxiety disorder. People with OCD often experience recurrent unwanted thoughts, called obsessions, and repetitive behaviors, called compulsions. These thoughts and behaviors interfere with everyday life to a great extent. Currently, the most frequently used psychosocial treatment for OCD is cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP). However, although effective, this treatment approach is largely inaccessible, time-consuming, labor-intensive, and expensive. A stepped-care approach to treating OCD may be more cost-effective and therefore more accessible for many individuals. Stepped-care CBT begins with the least expensive, least intrusive, most accessible option, and works up to the most expensive option if the less intrusive treatments do not work. This study will determine the benefits and cost-effectiveness of a stepped care treatment program for OCD.
Participants in this open label study will be randomly assigned to receive CBT for 6 to 14 weeks either through the stepped-care approach or immediately upon study entry. Participants will report to the study site for treatments and assessments on a regular basis, ranging from every 2 weeks to twice a week, depending on the stage of the study and the assigned treatment group. Stepped-care CBT will begin with self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement. If ineffective, this treatment will be followed by therapist-administered EX/RP. OCD symptoms will be assessed at Week 6. Participants who have responded to treatment after 6 weeks will not receive further treatment. All others will continue for an additional 8 weeks. These participants' OCD symptoms will be assessed again at Week 14. Participants assigned to the stepped-care approach whose OCD symptoms improved initially, but relapsed without further treatment by the Week 14 evaluation will receive full-scale CBT. Outcomes will be assessed again at 1- and 3-month follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional CBT | Active comparator | Behavioral: Traditional CBTCognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP) |
| Stepped-Care CBT | Experimental | Behavioral: Stepped-Care CBTStepped-care CBT |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary diagnosis of OCD of moderate or greater severity
- Presence of OCD symptoms for at least 1 year
Key exclusion criteria (4 listed)
- History of psychotic or developmental disorder
- Uncontrolled bipolar disorder
- Serious suicide risk
- Prior history of adequate CBT, including exposure and response prevention
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 |
|---|---|---|
| Traditional CBTCBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention. | Behavioural | Traditional CBT |
| Stepped-Care CBTIn the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP). | Behavioural | Stepped-Care CBT |
Primary outcome
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score
Time frame: Pretreatment, Posttreatment, and 3-month follow-up
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score was used as the outcome measure. The Y-BOCS is a clinician-rated scale assessing obsession (5 items) and compulsion (5 items) symptom severity on a 0 to 4 scale. All 10 items are added for the total score, with total scores ranging from 0 to 40, and higher numbers indicating more severe symptoms.
Treatment-related Total Cost Estimates
Time frame: Posttreatment
total estimated costs calculated based upon the fixed-dose schedule
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundTolin, D.F., Diefenbach, G.J., Maltby, N., & Hannan, S. (2005). Stepped care for obsessive-compulsive disorder: A pilot study. Cognitive and Behavioral Practice, 12, 403-414.
- Individual participant dataSharing planned: No
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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.
David F. Tolin, PhD principal investigator
Institute of Living/Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional CBT and Stepped-Care CBT in people with Obsessive-compulsive Disorder, run by Hartford Hospital at 1 site in United States.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) Total Score (time frame: Pretreatment, Posttreatment, and 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00316355, which also lists 1 linked publication.
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 22 Feb 2018.