Obsessive Compulsive DisorderPhase 1NCT01522287
Computer Assisted Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Comprehensive Stepped-Care Approach
A Phase 1 study testing Computer-Assisted Cognitive Behavior Therapy (BT STEPS) in people with Obsessive Compulsive Disorder, run by Center for Psychological Consultation at 1 site in United States.
Trial summary
The goal of this project is to improve access to effective treatments for obsessive compulsive disorder (OCD) through the use of web-based cognitive behavioral therapy (CBT) treatment. There intervention involves both a computer program (BT Steps) and human interaction via telephone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Computer-Assisted Cognitive Behavior Therapy (BT STEPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or above
- Have clinically significant OCD
- YBOCS score of 16-32
Who cannot join
- Significant comorbid depression
- Serious suicide risk
- Psychosis or psychotic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Psychological Consultation
Madison, Wisconsin, 53717
About this study
Official title: Computer Assisted CBT for OCD: A Comprehensive Stepped-Care Approach
The goal of this project is to improve access to effective treatments for obsessive compulsive disorder (OCD) through the use of web-based cognitive behavioral therapy (CBT) treatment. There intervention involves both a computer program (BT Steps) and human interaction via telephone. The investigators will test the efficacy and feasibility of computer therapy alone (n=35), computer plus a non-therapist coach (n=35), and computer plus a CBT therapist coach (n=35
Read the detailed description
The need for evidence-based mental health treatments i.e., 'treatment based on the best available science or research evidence"1, has been stressed from scientific, ethical, and marketing perspectives. While empirical evidence supports both the efficacy and effectiveness of cognitive behavior therapy (CBT) for Obsessive-Compulsive Disorder (OCD), demand for clinicians trained in these approaches far exceeds supply. New technologies provide the opportunity to facilitate access to this specialized treatment. A growing body of research has found that web-based self-administered psychotherapy is highly effective, cost-efficient, and can achieve clinical improvements similar to those obtained with clinician administered therapy. The long-term goal of this project is to improve clinical and occupational functioning and decrease disability associated with OCD by improving access to effective treatments through the use of web-based CBT treatment. The intervention involves a computer program (BT STEPS) and human interaction via telephone. The inclusion of human interaction for coaching and encouragement has been found to significantly increase compliance and success rates in computerized self-help. Whether treatment outcomes differ when this coaching is done by a therapist versus when done by a trained non-therapist has not been studied. This is the first program to examine a hybrid model involving different levels of remote clinician coaching in combination with an on-line self-help tutorial. In Phase I the investigators will test the efficacy and feasibility of computer therapy alone (n=35), computer plus nontherapist coach (n=35) and computer plus CBT therapist coach. In phase II the investigators will do a fully powered study comparing our model to traditional face-to-face therapy.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Computer-Assisted Cognitive Behavior Therapy (BT STEPS)
- Keywords
- Obsessive Compulsive Disorder, Computer Assisted Therapy, Cognitive Behavior Therapy, Cognitive Therapy
- 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.
Computer-Assisted Cognitive Behavior Therapy (BT STEPS)Behavioural
Also called Cogntive Therapy, Behavior Therapy, Cognitive-Behavior Therapy
BT STEPS is a computer-assisted self help treatment for OCD. Clients work through the program at their own pace.
| Study group | Role | What they receive |
|---|---|---|
| BT STEPS alone | Active comparator | Subjects assigned to BT STEPS without coaching will receive computer assisted Cognitive Behavior Therapy. They will receive a welcome and orientation call from the project manager and up to three automated reminder e-mails if there is no activity in the BT Steps website for 5 days. E-mails will describe most recent "step" the participant used and what to expect in upcoming steps. The focus of reminder messages is on the patient"s progress through BT STEPS. Receives: Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS) |
| BT Steps with non-therapist coaching | Active comparator | Subjects randomized to BT STEPS with coaching will receive computer assisted Cognitive Behavior Therapy plus regularly scheduled weekly coaching, encouragement and support via phone. Calls will focus on user's progress in BT STEPS, troubleshoot problems the participant is having with the program, and set progress goals for the next coaching session. Coaches will be supervised by the CBT therapist, and may consult with the CBT clinician as needed. Receives: Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS) |
| BT STEPS with therapist coaching | Active comparator | Subjects randomized to BT STEPS with therapist coaching will receive computer-assisted Cognitive Behavior Therapy plus regularly scheduled weekly coaching and support from a CBT therapist via phone. Calls will focus on user's progress in BT STEPS, troubleshoot problems the participant is having with the program, and set progress goals for the next coaching session. Receives: Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale (YBOCS)
YBOCS measures severity of obsessions and compulsions
Measured: Change from Baseline on YBOCS at 12 weeks
Secondary outcomes (2)
PHQ-9
PHQ-9 assesses the 9 core DSM symptoms of depression
Measured: Change from baseline on PHQ9 at 12 weeks
Work and Social Adjustment Scale (WSA)
Measures problems at work and social relationships
Measured: Change from baseline on WSA at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Psychological Consultation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522287
- Sponsor's protocol ID
- R43MH090612
- Status last verified
- Mar 2014
- First submitted
- 23 Jan 2012
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Greist JH, Marks IM, Baer L, Kobak KA, Wenzel KW, Hirsch MJ, Mantle JM, Clary CM. Behavior therapy for obsessive-compulsive disorder guided by a computer or by a clinician compared with relaxation as a control. J Clin Psychiatry. 2002 Feb;63(2):138-45. doi: 10.4088/jcp.v63n0209.
PubMed 11874215
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted CBT for OCD: A Comprehensive Stepped-Care Approach
- ClinicalTrials.gov ID
- NCT01522287
- Acronym / sponsor ID
- R43MH090612
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Obsessive Compulsive Disorder, Computer Assisted Therapy, Cognitive Behavior Therapy, Cognitive Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Center for Psychological ConsultationUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Jan 2012 (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 goal of this project is to improve access to effective treatments for obsessive compulsive disorder (OCD) through the use of web-based cognitive behavioral therapy (CBT) treatment. There intervention involves both a computer program (BT Steps) and human interaction via telephone. The investigators will test the efficacy and feasibility of computer therapy alone (n=35), computer plus a non-therapist coach (n=35), and computer plus a CBT therapist coach (n=35
Detailed description
The need for evidence-based mental health treatments i.e., 'treatment based on the best available science or research evidence"1, has been stressed from scientific, ethical, and marketing perspectives. While empirical evidence supports both the efficacy and effectiveness of cognitive behavior therapy (CBT) for Obsessive-Compulsive Disorder (OCD), demand for clinicians trained in these approaches far exceeds supply. New technologies provide the opportunity to facilitate access to this specialized treatment. A growing body of research has found that web-based self-administered psychotherapy is highly effective, cost-efficient, and can achieve clinical improvements similar to those obtained with clinician administered therapy. The long-term goal of this project is to improve clinical and occupational functioning and decrease disability associated with OCD by improving access to effective treatments through the use of web-based CBT treatment. The intervention involves a computer program (BT STEPS) and human interaction via telephone. The inclusion of human interaction for coaching and encouragement has been found to significantly increase compliance and success rates in computerized self-help. Whether treatment outcomes differ when this coaching is done by a therapist versus when done by a trained non-therapist has not been studied. This is the first program to examine a hybrid model involving different levels of remote clinician coaching in combination with an on-line self-help tutorial. In Phase I the investigators will test the efficacy and feasibility of computer therapy alone (n=35), computer plus nontherapist coach (n=35) and computer plus CBT therapist coach. In phase II the investigators will do a fully powered study comparing our model to traditional face-to-face therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BT STEPS alone | Active comparator | Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS)Subjects assigned to BT STEPS without coaching will receive computer assisted Cognitive Behavior Therapy. They will receive a welcome and orientation call from the project manager and up to three automated reminder e-mails if there is no activity in the BT Steps website for 5 days. E-mails will describe most recent "step" the participant used and what to expect in upcoming steps. The focus of reminder messages is on the patient"s progress through BT STEPS. |
| BT Steps with non-therapist coaching | Active comparator | Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS)Subjects randomized to BT STEPS with coaching will receive computer assisted Cognitive Behavior Therapy plus regularly scheduled weekly coaching, encouragement and support via phone. Calls will focus on user's progress in BT STEPS, troubleshoot problems the participant is having with the program, and set progress goals for the next coaching session. Coaches will be supervised by the CBT therapist, and may consult with the CBT clinician as needed. |
| BT STEPS with therapist coaching | Active comparator | Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS)Subjects randomized to BT STEPS with therapist coaching will receive computer-assisted Cognitive Behavior Therapy plus regularly scheduled weekly coaching and support from a CBT therapist via phone. Calls will focus on user's progress in BT STEPS, troubleshoot problems the participant is having with the program, and set progress goals for the next coaching session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or above
- Have clinically significant OCD
- YBOCS score of 16-32
Key exclusion criteria (3 listed)
- Significant comorbid depression
- Serious suicide risk
- Psychosis or psychotic 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 |
|---|---|---|
| Computer-Assisted Cognitive Behavior Therapy (BT STEPS)Also: Cogntive Therapy, Behavior Therapy, Cognitive-Behavior TherapyBT STEPS is a computer-assisted self help treatment for OCD. Clients work through the program at their own pace. | Behavioural | BT STEPS alone, BT STEPS with therapist coaching, BT Steps with non-therapist coaching |
Primary outcome
Yale Brown Obsessive Compulsive Scale (YBOCS)
Time frame: Change from Baseline on YBOCS at 12 weeks
YBOCS measures severity of obsessions and compulsions
2 secondary outcomes
PHQ-9
Time frame: Change from baseline on PHQ9 at 12 weeks
Work and Social Adjustment Scale (WSA)
Time frame: Change from baseline on WSA at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
- Background: PubMed 11874215Greist JH, Marks IM, Baer L, Kobak KA, Wenzel KW, Hirsch MJ, Mantle JM, Clary CM. Behavior therapy for obsessive-compulsive disorder guided by a computer or by a clinician compared with relaxation as a control. J Clin Psychiatry. 2002 Feb;63(2):138-45. doi: 10.4088/jcp.v63n0209.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computer-Assisted Cognitive Behavior Therapy (BT STEPS) in people with Obsessive Compulsive Disorder, run by Center for Psychological Consultation 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 3 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: finished, as of the sponsor's last update on 14 Mar 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (YBOCS) (time frame: Change from Baseline on YBOCS at 12 weeks). 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 NCT01522287, 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 14 Mar 2014.