Obsessive-Compulsive Disorder
Conditions
Brief 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).
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.
Interventions
BEHAVIORALOCFighter
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).
Sponsors
Hartford Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Failed to Start Treatment | 2 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Technical Problem | 1 |
| Overall Study | Time Constraints | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | OCFighter Participants |
|---|---|
| Age, Continuous | 37.08 years STANDARD_DEVIATION 12.57 |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 1 / 24 |
Outcome results
Primary
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
Population: Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OCFighter Participants | Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | Baseline (pre-treatment) | 24.67 units on a scale | Standard Deviation 5.16 |
| OCFighter Participants | Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | week 17 (post-treatment) | 18.29 units on a scale | Standard Deviation 9.06 |
| OCFighter Participants | Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | 6-month Follow-up | 18.46 units on a scale | Standard Deviation 7.79 |
Primary
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
Population: Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OCFighter Participants | Responder Status | Week 17 (post-treatment) | 5 participants |
| OCFighter Participants | Responder Status | 6- Month follow-up | 5 participants |