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CompletedNCT01659125Updated Jan 7, 2016Results posted

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

An interventional study of "OCFighter" in Obsessive-Compulsive Disorder, sponsored by Hartford Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2016-01-07.

Sponsored by Hartford Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 69 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Obsessive-Compulsive Disorder
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In context

Compulsive Personality Disorder

367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.

This study's enrollment of 26 is below the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.

Browse Compulsive Personality Disorder studies →

Lead sponsor

Hartford Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    OCFighter

    OCFighter

    Behavioral: "OCFighter"

Interventions

  • Behavioral"OCFighter"

    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).

    Also known as: OCFighter, Guided Self-help

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up

  2. 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).

    Time frame: Week 17 (post-treatment) and 6-month follow-up

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Results

Posted Jan 7, 2016

Participant flow

Participant flow — Overall Study
MilestoneOCFighter Participants
Started26
Initiated treatment24
Completed the posttreatment assessment17
Completed 3-month follow-up16
Completed 6-month follow-up12
Completed12
Not completed14
Withdrew: Withdrawal by subject2
Withdrew: Lost to follow-up7
Withdrew: Technical problem1
Withdrew: Time constraints2
Withdrew: Failed to start treatment2

Outcome measures

PrimaryChange 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.

Time frame:
Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up
Reported as:
Mean · units on a scale
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
units on a scaleOCFighter Participants
Baseline (pre-treatment)24.67 ± 5.16
week 17 (post-treatment)18.29 ± 9.06
6-month Follow-up18.46 ± 7.79
PrimaryResponder 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).

Time frame:
Week 17 (post-treatment) and 6-month follow-up
Reported as:
Number · participants
Responder Status
participantsOCFighter Participants
Week 17 (post-treatment)5
6- Month follow-up5

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
OCFighter Participants—1/24 (4.2%)0/24 (0%)
Most frequent serious events
Most frequent serious events
EventOCFighter Participants
Increased DepressionPsychiatric disorders1/24

Baseline characteristics

Age, Continuous
Age, Continuous(years)OCFighter Participants
Mean37.08 ± 12.57
Sex: Female, Male
Sex: Female, Male(Participants)OCFighter Participants
Female17
Male9
Region of Enrollment
Region of Enrollment(participants)OCFighter Participants
United States26
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Study locations

1 site
  • Hartford Hospital
    Hartford, Connecticut 06106, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01659125
Lead sponsor
Hartford Hospital
Responsible party
Sponsor
First posted
Aug 7, 2012
Start date
Aug 2012
Primary completion
Jun 2014
Completion
Jun 2014
Results posted
Jan 7, 2016
Last update
Jan 7, 2016

Study contacts

Gretchen Diefenbach, Ph.D.
principal investigator · Hartford Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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