Trial Outcomes & Findings for Effectiveness and Neuropsychological Predictors of Guided Self-Help for Obsessive-Compulsive Disorder (OCD) (NCT NCT01659125)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

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

Results posted on

2016-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	OCFighter Participants OCFighter "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).
Overall Study STARTED	26
Overall Study Initiated Treatment	24
Overall Study Completed the Posttreatment Assessment	17
Overall Study Completed 3-month Follow-up	16
Overall Study Completed 6-month Follow-up	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	OCFighter Participants OCFighter "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).
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	7
Overall Study Technical Problem	1
Overall Study Time Constraints	2
Overall Study Failed to Start Treatment	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OCFighter Participants n=26 Participants OCFighter "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).
Age, Continuous	37.08 years STANDARD_DEVIATION 12.57 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	OCFighter Participants n=24 Participants Participants who initiated treatment
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Baseline (pre-treatment)	24.67 units on a scale Standard Deviation 5.16
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) week 17 (post-treatment)	18.29 units on a scale Standard Deviation 9.06
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) 6-month Follow-up	18.46 units on a scale Standard Deviation 7.79

PRIMARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	OCFighter Participants n=24 Participants Participants who initiated treatment
Responder Status 6- Month follow-up	5 participants
Responder Status Week 17 (post-treatment)	5 participants

Adverse Events

OCFighter Participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OCFighter Participants n=24 participants at risk OCFighter "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).
Psychiatric disorders Increased Depression	4.2% 1/24 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Gretchen J. Diefenbach

Institute of Living

Phone: 860-545-7685

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place