protocolSection identificationModule nctId: NCT06388044, orgStudyIdInfo id: PRO00115010, briefTitle: ACT for Infertility: Case Series, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, descriptionModule briefSummary: In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT., conditionsModule conditions: Infertility, conditions: Psychological Distress, conditions: Acceptance and Commitment Therapy, conditions: Psychological Flexibility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Acceptance and Commitment Therapy, outcomesModule primaryOutcomes measure: Acceptability of the Intervention, secondaryOutcomes measure: Change in Fertility Problem Inventory (FPI), secondaryOutcomes measure: Change in Patient Health Questionnaire 9 (PHQ-9), secondaryOutcomes measure: Change in Patient Health Questionnaire 2 (PHQ-2), secondaryOutcomes measure: Change in Generalized Anxiety Disorder Questionnaire 7 (GAD-7), secondaryOutcomes measure: Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2), secondaryOutcomes measure: Change in Modified Differential Emotions Scale (mDES), secondaryOutcomes measure: Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15), secondaryOutcomes measure: Change in Intolerance of Uncertainty (IUS), secondaryOutcomes measure: Change in Valuing Questionnaire (VQ), secondaryOutcomes measure: Change in Values-Based Behavior, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke North Pavilion, city: Durham, state: North Carolina, zip: 27705, country: United States, contacts name: Francesca Scheiber, PhD, role: CONTACT, phone: 919-668-8696, email: fs158@duke.edu, contacts name: Julia Woodward, PhD, role: SUB_INVESTIGATOR, contacts name: Ashley Moskovich, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False