protocolSection identificationModule nctId: NCT06301360, orgStudyIdInfo id: KOSMOS2 2023-04956-01, briefTitle: Internet Based Emotional Awareness and Expression Therapy for Functional Somatic Disorder With and Without Therapist Support, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Daniel Maroti, class: OTHER, collaborators name: Wayne State University, descriptionModule briefSummary: Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned.Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT).The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms/functional somatic symptoms (MUS/FSD). The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created.The research question for this specific study is:Is internet-based Emotional Awareness and Expression Therapy (I-EAET) with therapist more effective than without therapist support for patients with FSD?, conditionsModule conditions: Functional Somatic Disorder, conditions: Somatic Symptom Disorder, conditions: Functional Somatic Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RCT with two treatment arms, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Internet based Emotional Awareness and Expression Therapy (I-EAET), outcomesModule primaryOutcomes measure: Patient Health Questionnaire -15 (PHQ-15), primaryOutcomes measure: Numeric Rating Scales according to EURONET-SOMA, secondaryOutcomes measure: Generalized Anxiety Disorder-7 (GAD-7), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Post traumatic stress disorder checklist-5 (PCL-5), secondaryOutcomes measure: Difficulties in Emotion Regulation Scale-16 (DERS-16), secondaryOutcomes measure: Sheehan Disability Scale (SDS), secondaryOutcomes measure: The revised illness perception questionnaire (IPQ-R), otherOutcomes measure: Mediational measure: DERS-16, otherOutcomes measure: Mediational measure: PHQ-15, otherOutcomes measure: Mediational measure: PHQ-4, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stockholm University, status: RECRUITING, city: Stockholm, zip: 10691, country: Sweden, contacts name: Daniel Maroti, Med Dr, role: CONTACT, phone: +46738028474, email: daniel.maroti@su.se, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Stockholm University, status: RECRUITING, city: Stockholm, zip: 11419, country: Sweden, contacts name: Daniel Maroti, role: CONTACT, phone: 0738028474, email: daniel.maroti@su.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False