Obsessive-Compulsive DisorderNCT01659125

Effectiveness and Neuropsychological Predictors of Guided Self-Help for Obsessive-Compulsive Disorder (OCD)

A study testing "OCFighter" in people with Obsessive-Compulsive Disorder, run by Hartford Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary aim of this study is to learn about who is most likely to benefit from guided self-help (GSH) for obsessive-compulsive disorder (OCD). 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?: "OCFighter"
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Aug 2012to Jun 2014
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

Principal or co-principal diagnosis of OCD
Clinical global impression score greater than or equal to 4
Y-BOCS score great than or equal to 8
Fluency in English
Capacity to understand the nature of the study and willingness to sign informed consent form

Who cannot join

Active manic episode, psychosis, pervasive developmental disorder, mental retardation
Concurrent OCD psychotherapy
Current threat of harm to self or others
Previous adequate trial of therapist-administered or self-administered exposure and response prevention for OCD

Trial locations and contacts

1 site in 1 country.

United States1 site

Hartford Hospital
Hartford, Connecticut, 06106

Other trials in United States

About this study

Official title: Effectiveness and Neuropsychological Predictors of Guided Self-Help for OCD

The primary aim of this study is to learn about who is most likely to benefit from guided self-help (GSH) for obsessive-compulsive disorder (OCD).

Read the detailed description

40 Participants with OCD will be recruited. They will be given access to OC Fighter, an internet OCD treatment program. During the 17 week program, participants will meet with a therapist 9 times. Assessments will occur at pretreatment, post-treatment, 3-month follow up and 6-month follow up.

Conditions: Obsessive-Compulsive Disorder
Being tested: "OCFighter"
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.

"OCFighter"Behavioural
Also called OCFighter, Guided Self-help
OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP).

Study groups in NCT01659125
Study group	Role	What they receive
OCFighter	Experimental	OCFighter Receives: Behavioral: "OCFighter"

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
The Y-BOCS is a semi-structured interview that assesses severity of obsessions and compulsions. The total score is reported here and ranges from 0 to 40 with higher scores indicating more severe OCD symptoms.
Measured: Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up
Responder Status
Participants who experienced a clinically significant change in Y-BOCS score defined as posttreatment YBOCS score that (a) has decreased by a reliable level (at least 1.96 times the standard deviation of that measure, taking into account the reliability of the measure itself; in this case, a decrease of 5 points or more), and (b) is within the nonclinical range of scores (in this case, a score of 13 or below).
Measured: Week 17 (post-treatment) and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Jun 2014

First posted7 Aug 2012 (estimated)
Study startAug 2012
Primary completionJun 2014
Study completionJun 2014

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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01659125
Sponsor's protocol ID: DIEF003581HI
Status last verified: Dec 2015
First submitted: 3 Aug 2012
Last updated: 7 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Treatment-refractory Obsessive-compulsive Disorder (trOCD)

All Obsessive-Compulsive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Neuropsychological Predictors of Guided Self-Help for OCD
ClinicalTrials.gov ID: NCT01659125
Acronym / sponsor ID: DIEF003581HI
Conditions: Obsessive-Compulsive Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Hartford HospitalUniversity, hospital or other
Study start: Aug 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 7 Aug 2012 (estimated)
Results: Posted 7 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary aim of this study is to learn about who is most likely to benefit from guided self-help (GSH) for obsessive-compulsive disorder (OCD).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OCFighter	Experimental	Behavioral: "OCFighter"OCFighter

Who may qualify

Ages: 18 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Principal or co-principal diagnosis of OCD
Clinical global impression score greater than or equal to 4
Y-BOCS score great than or equal to 8
Fluency in English
Capacity to understand the nature of the study and willingness to sign informed consent form

Key exclusion criteria (4 listed)

Active manic episode, psychosis, pervasive developmental disorder, mental retardation
Concurrent OCD psychotherapy
Current threat of harm to self or others
Previous adequate trial of therapist-administered or self-administered exposure and response prevention for OCD

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
"OCFighter"Also: OCFighter, Guided Self-helpOCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP).	Behavioural	OCFighter

Primary outcome

Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Time frame: Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up
The Y-BOCS is a semi-structured interview that assesses severity of obsessions and compulsions. The total score is reported here and ranges from 0 to 40 with higher scores indicating more severe OCD symptoms.
Responder Status
Time frame: Week 17 (post-treatment) and 6-month follow-up
Participants who experienced a clinically significant change in Y-BOCS score defined as posttreatment YBOCS score that (a) has decreased by a reliable level (at least 1.96 times the standard deviation of that measure, taking into account the reliability of the measure itself; in this case, a decrease of 5 points or more), and (b) is within the nonclinical range of scores (in this case, a score of 13 or below).

Results and safety

Results posted to the registry on 7 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OCFighter Participants	26	12

Primary outcome: Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

Time frame: Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	OCFighter Participants n = 24
Baseline (pre-treatment)	24.67 (5.16)
week 17 (post-treatment)	18.29 (9.06)
6-month Follow-up	18.46 (7.79)

Population analysed: Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).

Primary outcome: Responder Status

Time frame: Week 17 (post-treatment) and 6-month follow-up. Number. Unit: participants

Measure	OCFighter Participants n = 24
Week 17 (post-treatment)	5
6- Month follow-up	5

Population analysed: Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OCFighter Participants	1 of 24 (4.2%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obsessive-Compulsive Disorder

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.

Gretchen Diefenbach, Ph.D. principal investigator

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 "OCFighter" 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 5 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 7 Jan 2016. 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 7 Jan 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?

Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) (time frame: Baseline (pretreatment), 17-weeks (posttreatment), and 6 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 NCT01659125.

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 7 Jan 2016.