protocolSection identificationModule nctId: NCT06332066, orgStudyIdInfo id: 0046-24-COM, briefTitle: Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Shalvata Mental Health Center, class: OTHER, collaborators name: Clalit Health Services, descriptionModule briefSummary: In recent years there is a great interest in the possible role of Oxytocin (OT) as a facilitator for enhancing psychotherapeutic processes in patients with mental illnesses. Specific studies explored OT administration to patients, and the effect on psychotherapy on interaction within the therapeutic dyad. Nonetheless, studies exploring OT's effects of the therapists' side of the therapeutic dyad on the psychotherapy session and outcome, have not been conducted. The current study aims to assess the effect of OT administration to the therapists of psychiatric outpatients, on treatment process and outcome and specifically on the patient and therapist experience of the attunement and responsiveness toward the patient in the therapeutic encounter. Twenty staff members from Teradion Mental health Clinic of Clalit Health Services will be recruited, as well as 100 patients treated by these staff members. Therapists agreeing to participate will receive OT and PLC in a random order, at the same day they are seeing the same patients and the consecutive week. Patients agreeing to participate will complete a demographic questionnaire and all study measures, and will be scheduled to perform two consecutive research sessions with their therapists. The therapist will receive either OT or PLC in each of these two sessions, and right after the session the patients will complete the assessment scales. Multilevel models will be performed by the investigators to assess the effects of OT administration in therapists receiving OT versus receiving placebo. This research will be performed in accordance with ethical principles of Helsinki WMA Declaration. This study is the first to assess the effectiveness of hormonal augmentation for therapists and its influence on therapeutic process with patients suffering from acute distress in the public mental health domain., conditionsModule conditions: Mental Health Therapists, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Oxytocin nasal spray, outcomesModule primaryOutcomes measure: Attunement and Responsiveness towards patients, secondaryOutcomes measure: Attachment with Therapist, secondaryOutcomes measure: Working Alliance with Therapist, secondaryOutcomes measure: Patient Symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mental Health Clinic, Teradion, city: Misgav, country: Israel, contacts name: Ayelet Nir,, M.A., role: CONTACT, phone: 972-4-6025050, email: ayeletni1@clalit.org.il, contacts name: Galit, role: CONTACT, phone: 972-4-6026050, geoPoint lat: 32.86017, lon: 35.26165, hasResults: False