The objective of this feasibility study is to evaluate the feasibility, acceptability, and potential usefulness of the investigational device, a mobile software application (app) (OC Free) for treatment of OCD (contamination obsession only), adjunctive to individuals receiving outpatient ERP therapy. OC Free is an iOS/Android app that provides treatment via computerized exposure and response prevention (ERP). The study will evaluate preliminary safety and effectiveness of the app using gold-standard, validated 'clinician-administered' and 'self-reporting measures.'
Obsessive Compulsive Disorder (OCD) is characterized by the presence of obsessions and/or compulsions that cause clinically significant distress or impairment in multiple areas of functioning. It has a lifetime prevalence of 1-3% and is considered 1 of the 10 most debilitating diseases by the World Health Organization (WHO). One of the most common types of OCD, affecting up to 46% of OCD patients, is characterized by severe contamination fears and excessive washing behaviors. These patients feel anxious even after incidents of minor "contamination" (for example, touching a door knob), and may spend up to several hours painstakingly washing and scrubbing their hands, sometimes causing bleeding and skin damage. Exposure and Response Prevention (ERP) treatment is often considered as a first-line intervention for contamination OCD in mild to moderate cases. It is a behavioral therapy with the strongest evidence that exposes patients to situations that provoke their obsessive thoughts while helping them cope with their compulsive rituals. Through repetitive "exposure" and "response prevention," patients with contamination OCD can recognize that the dreaded outcome of their obsession is not likely. Though ERP treatment may be the first-line and most effective psychotherapeutic intervention for contamination OCD, not everyone treated in this intervention show recovery. In fact, many patients fail to complete all of their ERP tasks such as engaging in the homework or ritual prevention techniques outside of the sessions. Therefore, there is an immediate need to encourage patients to engage ERP tasks between the therapy sessions and increase the retention rate of ERP treatment. To address the unmet needs described above, the proposed intervention is intended to encourage patients to complete their ERP tasks at home and increase retention in outpatient ERP therapy programs. This study aims to evaluate the clinical effectiveness and safety of an ERP - based digital treatment for patients with contamination OCD. The study will enroll up to 30 male or female subjects aged 18 years and older with a primary diagnosis of OCD based on the criteria. Subjects should have OCD with prominent contamination fears and obsessions as measured on the Padua Inventory Contamination Fear Subscale. Enrolled patients will receive ERP via OC Free for a 6-week treatment period, followed by a 4-week follow-up period to measure preliminary effectiveness and safety. The obsessive-compulsive symptom improvement (difference between baseline and end of treatment) will be determined by the Yale-Brown Obsessive-Compulsive scale (Y-BOCS). All subjects who have completed treatment with OC Free will be re-evaluated with the Y-BOCS 4 weeks after the end of the treatment (Week 10).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
OC Free is a 6-week ERP-based intervention to deliver Exposure and Response Prevention (ERP) to reduce the anxiety from obsessive thoughts and compulsive rituals.
Spectrum Neuroscience and Treatment Institute
New York, New York, United States
RECRUITINGYale-Brown Obsessive-Compulsive Scale (Y-BOCs)
The Y-BOCS is the gold-standard, semi-structured clinician-administered assessment of OCD severity. It contains 10 items ranging from 0 to 4, which are summed to generate a total score (range = 0-40). Higher scores indicate more severe OCD symptoms. The Y-BOCS will be used to assess change in OCD symptoms from baseline to endpoint.
Time frame: Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)
Clinical Global Impression - Improvement scale (CGI-I)
The CGI-I is a single-item clinician-rated measure of global improvement. Scores range from 1 (very much improved) to 7 (very much worse), with scores of 1 or 2 (much improved) indicating positive treatment response.
Time frame: Endpoint (week 6), Follow-up (week 10)
Clinical Global Impression-Severity Scale (CGI-S)
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. Scores range from 1 (Normal - not at all ill, symptoms of disorder not present past seven days) to 7 (extremely ill - pathology drastically interferes in many life functions; may be hospitalized).
Time frame: Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)
Beck Depression Inventory II
The BDI is a 21 item self-reporting measure of depression, rated on a 0-3 scale, with responses being specific to the questions. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.
Time frame: Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)
Beck Anxiety Inventory
The BAI is a 21 item self-reporting measure of anxiety, rated on a 0-3 scale, with 0 being not at all to 3 being severely-it bothered me a lot. A total score of 0-7 is interpreted as a "Minimal" level of anxiety; 8-15 as "Mild"; 16-25 as "Moderate", and; 26-63 as "Severe".
Time frame: Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)
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