Rogers Memorial Hospital Incorporated

TREATING OBSESSIVE-COMPULSIVE DISORDER DURING THE PERINATAL PERIOD - PROJECT SUMMARY/ABSTRACT THE PERINATAL PERIOD (PREGNANCY THROUGH ONE YEAR AFTER GIVING BIRTH) IS A TIME OF SIGNIFICANTLY ELEVATED RISK FOR BOTH THE ONSET AND EXACERBATION OF OBSESSIVE-COMPULSIVE DISORDER (OCD). OCD IS DEBILITATING AND COSTLY IN THE GENERAL POPULATION, BUT FOR PERINATAL WOMEN UNTREATED OCD CONFERS A HOST OF ADDITIONAL RISKS RANGING FROM SERIOUS DELIVERY COMPLICATIONS TO DELETERIOUS HEALTH OUTCOMES FOR BOTH THE PARENT AND INFANT. ALTHOUGH EFFECTIVE TREATMENTS FOR OCD EXIST, PARTICULARLY EXPOSURE AND RESPONSE PREVENTION (ERP) AND SEROTONIN REUPTAKE INHIBITORS (SRIS), THESE TREATMENTS HAVE NOT BEEN SYSTEMATICALLY STUDIED IN PERINATAL WOMEN IN PART BECAUSE PREGNANT INDIVIDUALS HAVE BEEN EXCLUDED FROM CLINICAL TRIALS DUE TO SAFETY CONCERNS. HOWEVER, PERINATAL WOMEN ARE PHYSIOLOGICALLY AND PSYCHOLOGICALLY DISTINCT FROM THE NON-PERINATAL SAMPLES ON WHOM ERP AND SRIS WERE EMPIRICALLY TESTED, AND THERE ARE MANY REASONS TO EXPECT THAT THE UNIQUE BIOLOGICAL AND PSYCHOSOCIAL CONTEXT OF PERINATAL WOMEN MIGHT UNDERMINE THE EFFICACY, TOLERABILITY, AND SAFETY OF FIRST-LINE OCD TREATMENTS. DESPITE THE DEARTH OF DATA AND THE NUMEROUS WAYS THAT PERINATAL-SPECIFIC CONSIDERATIONS ALTER THE TREATMENT CONTEXT, BOTH PREGNANT AND POSTPARTUM WOMEN SUFFERING FROM OCD ROUTINELY PRESENT TO REAL-WORLD CLINICAL SETTINGS SEEKING TREATMENT. TO RESPOND TO THIS MATERNAL AND FILIAL HEALTH CRISIS, RESEARCH IS URGENTLY NEEDED TO DETERMINE IF FIRST- LINE OCD TREATMENTS ARE EFFECTIVE, SAFE, AND TOLERABLE FOR PERINATAL WOMEN, AND HOW STANDARD CARE NEEDS TO BE TAILORED TO FIT THE PERINATAL CONTEXT. THIS PROPOSAL WILL LEVERAGE EXISTING PATIENT DATA COLLECTED AS PART OF STANDARD CARE AT A LARGE NATURALISTIC BEHAVIORAL HEALTHCARE SYSTEM TO ADDRESS THIS CRITICAL, YET DIFFICULT TO STUDY, CLINICAL ISSUE AND INFORM LARGER-SCALE RANDOMIZED-CONTROLLED TRIALS (RCTS) AIMED AT IMPROVING OUTCOMES FOR BIRTHING PARENTS AND THEIR FAMILIES. USING THE LARGEST PERINATAL OCD SAMPLE TO DATE (N = 94; 43 PREGNANT, 51 POSTPARTUM) AND AN EQUAL NUMBER OF PROPENSITY-SCORE-MATCHED NON-PERINATAL CONTROLS (TOTAL N = 188), THIS STUDY WILL IMPLEMENT A CASE-CONTROL DESIGN, RETROSPECTIVE CHART REVIEW, AND STATISTICAL MODELING TO EVALUATE THE FOLLOWING AIMS: 1) DETERMINE WHICH INTERVENTIONS ARE ADMINISTERED TO PERINATAL PATIENTS WITH OCD IN A NATURALISTIC SETTING; 2) EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF FIRST-LINE OCD TREATMENTS IN THE PERINATAL PERIOD; AND, 3) TO INFORM PERSONALIZING EFFORTS, EXPLORE HOW STANDARD TREATMENTS ARE ADAPTED FOR USE WITH PERINATAL PATIENTS AND WHETHER THESE MODIFICATIONS IMPROVE OUTCOMES. THIS PROPOSAL IS IN LINE WITH THE STRATEGIC RESEARCH PRIORITIES SET FORTH BY THE NIMH PERTAINING TO INVESTIGATING PERSONALIZED INTERVENTION STRATEGIES (OBJECTIVE 3.2.A), ESTABLISHING THE SAFETY AND EFFICACY OF INTERVENTIONS FOR WOMEN AT VARIOUS PHASES OF THE REPRODUCTIVE CYCLE (INTEREST AREA 3), AND THE NEED FOR ADDITIONAL RESEARCH ON WOMEN’S MENTAL HEALTH DURING THE PERINATAL PERIOD (NOT-MH-21-270). THIS STUDY WILL PROVIDE PRELIMINARY DATA ATTESTING TO THE SAFETY, TOLERABILITY, AND EFFICACY OF STANDARD AND MODIFIED OCD TREATMENTS IN THE PERINATAL PERIOD, THEREBY JUSTIFYING THE INCLUSION OF PREGNANT PARTICIPANTS IN A LARGER-SCALE RCT TO BE PROPOSED IN A SUBSEQUENT R61/R33 APPLICATION AND INFORMING THE NATURE OF THE TREATMENTS TO BE EVALUATED.