An ERP-based Mobile Intervention as an Adjunctive Treatment for OCD

Inclusion Criteria:

• Ages 18 years and older
• Primary DSM-5 diagnosis of obsessive-compulsive disorder
• Mild to Moderate OCD severity (8 ≤ Y-BOCS ≤ 23)
• Subjects must currently be engaged (initiated and ongoing) in formal psychotherapy,ERP, prior to enrollment
• Subjects currently on medication that wish to participate in the study: Taking aconfirmed adequate and stable dose of a Serotonin Reuptake Inhibitor (SRI) orSelective Serotonin Reuptake Inhibitor (SSRI), as determined by the Investigator, forat least 6 consecutive weeks prior to screening
• Confirmed contamination fears, as defined by a score of at least 10 points on thePadua Inventory Contamination Fear Subscale 30 (PI CF) during the initial telephonescreening and at least 9 on the PI CF during the first laboratory testing session
• CGI-Severity score ≥ 2
• Currently living in the United States
• Ability to read, write, and comprehend English
• Patient willing to provide informed consent

Exclusion Criteria:

• Subjects who are study site staff members or subjects who are employees directlyinvolved in the conduct of the study
• Subjects with a history of at least two (2) treatment failures with a SerotoninReuptake Inhibitor (SRI) and/or Selective Serotonin Reuptake Inhibitor (SSRI) at aconfirmed adequate dose and for an adequate duration, as determined by theinvestigator
• Severe and extreme OCD severity (Y-BOCS ≥ 24)
• Current or previous symptoms of psychosis, including delusions, or history consistentwith a psychotic disorder, in the opinion of the investigator
• Current or previous compulsions that may place the subject or others at risk, in theopinion of the Investigator
• History of a violent tendencies, action(s) or thoughts or predilection towardsviolence in the opinion of the Investigator
• Any comorbid diseases or disorders (as determined by clinical judgement and supportedby the MINI v.6 diagnostic instrument) that significantly elevates the risk of studyparticipation or obscure the evaluation of effectiveness (e.g., psychotic disorders,Major Depressive Disorder, Bipolar Disorder, evidence of dementia or other CognitiveDisorder)
• Baseline C-SSRS: answer of yes to items 3, 4 or 5 within previous 12-month period)and/or BDI-II Exclusion (item 9, score of 2 or 3)
• History of one or more suicide attempts (in the last 12 months) or subjects who, inthe opinion of the investigator, present a serious risk of suicide, determined also byC-SSRS
• Subjects presenting a risk for self-harm or self-injurious behavior(s) or a risk ofharming others (in the last 12 months) as judged by the investigator in consultationwith the medical monitor
• Current severe substance use disorder as determined by the M.I.N.I diagnosticinstrument excluding caffeine
• Vision or hearing impairment that, in the opinion of the Investigator, might reduce,limit or adversely affect the subject's ability to comply with the requirements of thestudy or might affect the integrity of the data
• Does not own a supported mobile smartphone with a data plan
• Any physical, medical (including psychiatric) or other condition that, in the opinionof the investigator, might reduce, limit or adversely affect the subject's ability tocomply with the requirements of the study or might affect the integrity of the data
• Use of a smartphone app in past for treatment of any psychiatric disorder, includingOCD, depression or anxiety disorder
• A history of addiction to, dependence on, abuse of, misuse of, distribution of or useof any substance, including alcohol and nicotine, within the past one year