[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"somatic-symptom-disorder-dsm-5\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:somatic-symptom-disorder-dsm-5":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,51,82,118,147],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100641903","an-ecological-momentary-intervention-for-the-reduction-of-impairment-in-somatic-symptom-disorder-100641903",false,"NCT07646509","An Ecological Momentary Intervention for the Reduction of Impairment in Somatic Symptom Disorder","Inclusion Criteria:\n\n* Somatic Symptom Disorder\n\nExclusion Criteria:\n\n* chronic physical illnesses that fully explain the somatic symptoms\n* current psychotic disorder\n* current bipolar disorder\n* current self-harming behavior\n* current suicidality\n* current psychotherapy\n* alcohol, drug, or medication dependence within the past 6 months","ALL","18 Years","65 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","Persistent somatic symptoms significantly impair the daily lives of individuals with Somatic Symptom Disorder (SSD). Negative psychological factors (NPFs), such as catastrophizing and negative affectivity, further compound this impairment. Yet, few studies have examined strategies in daily life that directly target somatic symptoms and their dynamic relationship with NPFs. The goal of this clinical trial is to investigate if an Ecological Momentary Intervention (EMI) using music listening and cognitive reappraisal can reduce the intensity of and impairment due to somatic symptoms in 40 individuals with Somatic Symptom Disorder (SSD), aged 18-65 years.\n\nParticipants will report symptom intensity, impairment, and NPFs up to four times daily via a smartphone app over a six-week period. Using an intraindividual randomized controlled design, during weeks two to five, participants will be randomly assigned in the ratio of 50:25:25 to no intervention, music listening, and cognitive reappraisal, both at fixed times (evening measurement) and during episodes of acute somatic impairment.",[26,27,28,29,30],"Somatic Symptom Disorder (DSM-5)","Impairment","Psychological Factors","Persistent Physical Symptoms","Medically Unexplained Symptoms",[32,33,34,35,36,37],"Ecological Momentary Intervention","Persistent Somatic Symptoms","Daily Life","Music","Cognitive reappraisal","Somatic Symptom disorder","RECRUITING","2026-06-09",{"date":41,"type":42},"2026-06-12","ACTUAL",{"date":44,"type":42},"2025-06-26",{"date":46,"type":20},"2026-10",{"name":48,"class":49},"University of Vienna","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100617806","transcranial-alternating-current-stimulation-for-refractory-constipation-with-somatic-symptom-disorder-100617806","NCT07323407","Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder","A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Transcranial Alternating Current Stimulation (tACS) for the Treatment of Refractory Constipation Comorbid With Somatic Symptom Disorder","RELIEF-tACS","Inclusion Criteria:\n\n1. Diagnosis of Functional Constipation (FC): Subjects must meet the diagnostic criteria for functional constipation as defined by the Rome IV criteria.\n2. Low Frequency of Complete Spontaneous Bowel Movements (CSBM): During the 2-week screening period, subjects must have ≤2 complete spontaneous bowel movements per week.\n3. Poor Response to Previous Treatment: Subjects must have been dissatisfied with prior treatments for functional constipation and have undergone at least 3 months of therapy (including laxatives or other prokinetic agents).\n4. Diagnosis of Somatic Symptom Disorder (SSD): Subjects must meet the DSM-5 diagnostic criteria for somatic symptom disorder (SSD). All subjects will undergo a semi-structured clinical interview based on DSM-5 criteria, conducted by professionals trained in SSD diagnosis.\n\n   * Criterion A: Presence of one or more distressing somatic symptoms that significantly affect daily life.\n   * Criterion B: At least one of the following must be met:\n\n     1. Excessive and persistent thoughts about the severity of symptoms;\n     2. Persistently high levels of anxiety about health or symptoms;\n     3. Excessive time and energy devoted to health concerns or symptoms.\n   * Criterion C: Symptoms must persist for at least 6 months.\n5. Age Range: Subjects must be between 18 and 80 years old.\n6. No Concurrent Clinical Trials: Subjects must not participate in any other clinical trials during the study period.\n7. Informed Consent: Subjects must voluntarily agree to participate and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Presence of organic diseases (such as tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, etc.), endocrine disorders (e.g., hypothyroidism), metabolic diseases (diabetes, thyroid dysfunction), or neurological disorders (e.g., Parkinson's disease);\n2. Long-term use of medications that may affect intestinal function or induce constipation, such as Parkinson's drugs (excluding conventional laxatives, antidiarrheals, or intestinal stimulants; during the trial, participants are only allowed to take prescribed emergency medications, with detailed records of usage required);\n3. History of chronic pain or substance abuse, such as opioids;\n4. Diagnosed mental disorders with psychotropic medication use for over 3 months prior to the visit, or history of psychotropic or hormonal medication use for over 3 months;\n5. Individuals at risk of self-harm or suicide, as assessed by a psychiatrist, or those requiring psychosomatic intervention;\n6. History of allergy to psychiatric medications (e.g., fluoxetine), or contraindications to fluoxetine such as liver\u002Fkidney impairment or prolonged Q-T interval on ECG;\n7. Pregnant or breastfeeding women;\n8. Patients with benign or malignant tumors or autoimmune diseases;\n9. Chronic conditions requiring long-term medication that may affect quality of life or interfere with examinations\u002Ftreatment, including cardiovascular diseases, coagulation disorders or regular anticoagulant use (warfarin\u002Fheparin), liver\u002Fkidney diseases, organ failure, cognitive impairment, aphasia, etc.","80 Years",{"count":61,"type":20},60,[23],"The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) in adults with refractory functional constipation comorbid with somatic symptom disorder. This population is characterized by persistent bowel dysfunction despite conventional treatments, frequent reliance on laxatives, and evidence of impaired brain-gut regulation contributing to chronic symptoms.\n\nThe study focuses on three primary domains:\n\nEfficacy - Bowel Function:\n\n• Assessment of whether a 4-week course of tACS improves bowel activity, measured by changes in Complete Spontaneous Bowel Movements (CSBM) and overall bowel-movement frequency over the treatment and follow-up period.\n\nEfficacy - Symptom and Quality of Life Burden:\n\n• Evaluation of the effect of tACS on constipation-related severity and patient-reported outcomes, including the Patient Assessment of Constipation-Symptoms (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL).\n\nSafety and Tolerability:\n\n• Documentation of adverse events associated with tACS, with particular attention to incidence, intensity, and overall patient tolerability compared with sham stimulation.",[65,26,66],"Functional Constipation (FC)","Refractory Constipation",[68,69,70,71],"Functional Constipation","Somatic Symptom Disorder","refractory constipation","transcranial alternating current stimulation","2026-01-07",{"date":74,"type":42},"2026-01-09",{"date":76,"type":42},"2025-08-20",{"date":78,"type":20},"2026-12-01",{"name":80,"class":49},"Xijing Hospital of Digestive Diseases",2,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":102,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":81},"100585999","ultra-brief-psychological-treatments-for-emotional-symptoms-and-disorders-100585999","NCT06909669","Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders","Ultra-brief Psychological Treatments for Emocional Symptoms and Disorders: An Efficacy and Efficiency Analysis","UltraPsyBrief","Inclusion Criteria:\n\n\\- Patients presenting negative emotional symptomatology (anxiety, depression or somatizations), mild or moderate. Specifically, they will be included in the study if they present a score ≥ 5 on the PHQ-9, the GAD-7 or the PHQ-15.\n\nExclusion Criteria:\n\n* Bipolar disorder, personality disorder, psychosis or substance abuse, indicated by SCID-5-CV\n* Recent suicide attempt.\n* Severe emotional symptoms (PHQ-15 or GAD-7 ≥ 15; or PHQ-9 ≥ 20).",{"count":91,"type":20},184,[23],"The main objective of this randomized clinical trial is to study if various modalities of brief (eight sessions) and ultra-brief (four sessions) transdiagnostic cognitive-behavioral treatment work for decrease emotional symptoms and disorders, as well as to find out which variables of cognition and of the intervention process itself are involved in the therapeutic improvement.\n\nThe investigators will compare the interventions of four groups: brief group treatment (1), ultra-brief group treatment (2), ultra-brief individual treatment (3) with the ultra-brief relaxation (control) group.\n\nThe main questions the study aims to answer are:\n\n* Will the brief and ultra-brief treatment formats works better than the relaxation-based control group?\n* Will results obtained between the brief group therapy group and the ultra-brief group therapy group be similar?\n* Will the individual ultra brief therapy be more effective than the two group therapies because of common factors, such as the therapeutic alliance?\n* Will group therapies be more beneficial for cost and in terms of capability to reduce emocional symptoms than individual therapy? Participants will be randomly assigned to each of the groups and will receive the corresponding treatment, with different number of sessions. They will answer a series of questionnaires at the beginning and at the end of the intervention, as well as 3 months and 6 months after the end of the treatment.",[95,96,97,98,99,26,100,101],"Depression - Major Depressive Disorder","Generalized Anxiety Disorder","Generalized Anxiety","Anxiety","Somatoform Disorders","Somatization","Emotional Disorders",[103,104,105,106,107],"ultra-brief therapy","brief therapy","transdiagnostic therapy","cognitive-behavioral therapy","randomized controled trial","NOT_YET_RECRUITING","2025-12-15",{"date":111,"type":42},"2025-12-22",{"date":113,"type":20},"2026-02",{"date":115,"type":20},"2028-09",{"name":117,"class":49},"Universidad de Córdoba",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":81},"100554980","phase-1-evaluation-of-fluoxetine-for-refractory-constipation-with-somatic-symptom-disorder-features-100554980","NCT06506136","Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features","Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Fluoxetine in Patients With Refractory Constipation Exhibiting Somatic Symptom Disorder Features","REFLECT","Participants in this study were recruited from a real-world outpatient constipation patient registry platform, which provides a comprehensive case database to support evidence-based research. Based on the characteristics of the primary target population identified in previous studies of fluoxetine, participants with refractory constipation were selected from the registry according to the following criteria:\n\nAll participants were required to meet the Rome IV diagnostic criteria for functional constipation.Specifically: 1) At least two of the following symptoms must be present during more than 25% of defecations: straining; lumpy or hard stools; sensation of incomplete evacuation; sensation of anorectal obstruction\u002Fblockage; manual maneuvers to facilitate defecation; fewer than three spontaneous bowel movements per week; 2) Loose stools are rarely present without the use of laxatives; 3) The criteria for IBS were not met.\n\nSymptoms must have been present for at least six months prior to diagnosis, with the diagnostic criteria fulfilled during the last three months. Participants who met the diagnostic criteria were further assessed against the inclusion and exclusion criteria outlined below. Patients who did not meet any inclusion criteria or met any exclusion criteria were not recruited.\n\nInclusion criteria\n\n1. Diagnosis of Functional Constipation (FC): Participants must meet the diagnostic criteria for functional constipation according to Rome IV criteria.\n2. Low CSBM Frequency: During the 2-week screening period, participants must experience Complete Spontaneous Bowel Movements (CSBM) ≤ 2 times per week.\n3. Unsatisfactory Previous Treatments: Participants must have been dissatisfied with previous treatments for functional constipation, having undergone at least 3 months of treatment, including laxatives or other prokinetic agents.\n4. Diagnosis of Somatic Symptom Disorder (SSD): Participants must meet the diagnostic criteria for Somatic Symptom Disorder (SSD) according to DSM-5. All participants will undergo a semi-structured clinical interview based on DSM-5 criteria, conducted by professionals trained in SSD diagnosis.\n\n   4.1. Criterion A: One or more physical symptoms that cause significant discomfort and\u002For disruption in daily life.\n\n   4.2. Criterion B: At least one of the following: 1) Excessive and persistent thoughts about the severity of symptoms. 2) Persistent high anxiety about health or symptoms. 3) Excessive time and energy spent on health concerns or symptoms.\n\n   4.3. Criterion C: The symptoms have persisted for at least 6 months.\n5. Age Range: Participants must be between the ages of 18 and 60 years.\n6. Not Participating in Other Ongoing Trials: Participants must not be involved in any other clinical trials during the study period.\n7. Informed Consent: Participants must voluntarily agree to participate in the study and sign an informed consent form.\n\nExclusion criteria\n\n1. Organic Diseases: Participants with organic diseases (e.g., tuberculosis, Crohn's disease, tumors, congenital megacolon), endocrine disorders (e.g., hypothyroidism), metabolic diseases (e.g., diabetes, thyroid dysfunction), or neurological disorders (e.g., Parkinson's disease).\n2. Use of Medications Affecting Bowel Function: Participants who require long-term use of medications that may affect bowel function or induce constipation, such as Parkinson's medications, except for routine laxatives, antidiarrheal agents, and intestinal stimulants. Note: During the trial, participants are only allowed to use the specified emergency medications, and all medication use must be carefully recorded.\n3. Chronic Pain or Substance Abuse: Participants with a history of chronic pain lasting more than 6 months or with a pain score ≥4 (based on the visual analog scale), or a history of substance abuse.\n4. Mental Health Disorders: Participants diagnosed with psychiatric disorders before the study and continuously using psychiatric medications for more than 3 months, or those with a history of using psychiatric medications and\u002For corticosteroids for more than 3 months before the study.\n5. Self-harm or Suicide Risk: Participants with a risk of self-harm or suicide, as assessed by a psychologist, or those requiring psychophysical interventions.\n6. Allergic Reactions or Contraindications to Psychiatric Medications: Participants with a history of allergy to psychiatric medications, including fluoxetine, or those with liver or kidney dysfunction, or any contraindications for fluoxetine, such as prolonged QT interval on ECG.\n7. Pregnant or Breastfeeding Women: Pregnant or breastfeeding women.\n8. Other Malignant or Benign Tumors: Participants with other malignant or benign tumors or autoimmune diseases.\n9. Chronic Diseases Impacting Life Quality: Participants with cardiovascular diseases, clotting disorders (e.g., those on long-term warfarin or heparin therapy), liver or kidney diseases, organ failure, cognitive disorders, aphasia, or any other chronic diseases requiring long-term medication, which may significantly affect their quality of life and the evaluation of treatment outcomes.","60 Years",{"count":128,"type":20},194,[130,131],"PHASE1","PHASE2","The purpose of this randomized, double-blind, placebo-controlled trial is to determine whether fluoxetine is effective and safe for adults with refractory constipation that exhibits Somatic Symptom Disorder (SSD) features-namely, persistent preoccupation with bowel function, heightened perception of defecatory discomfort, and clinically significant somatic symptom burden (PHQ-15 ≥ 10) in the absence of IBS-C abdominal pain criteria.\n\nThe study will address three primary questions:\n\nEfficacy-Bowel Function:\n\n• Does 12 weeks of fluoxetine increase Complete Spontaneous Bowel Movements (CSBM) and overall bowel-movement frequency compared with placebo?\n\nEfficacy-Somatic Symptom Burden:\n\n• Does fluoxetine reduce SSD severity, as measured by the Patient Health Questionnaire-15 (PHQ-15) and the Somatic Symptom Scale-8 (SSS-8)?\n\nSafety and Tolerability:\n\n• What adverse events occur during fluoxetine treatment, and how do their incidence and intensity compare with placebo?",[66,26,65],[70,135,136,137],"fluoxetine","somatic symptom disorder","functional constipation","2025-08-03",{"date":140,"type":42},"2025-08-06",{"date":142,"type":20},"2025-09-01",{"date":144,"type":20},"2027-05-30",{"name":146,"class":49},"Zhifeng Zhao, PhD",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":162,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100564648","emotional-awareness-and-expression-therapy-for-patients-with-persistent-physical-symptoms-in-routine-psychiatric-care-a-pilot-study-100564648","NCT06631911","Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms in Routine Psychiatric Care: A Pilot Study","EAET for PPS","Inclusion Criteria:\n\n* The participant certifies that they have undergone a medical assessment for their physical symptoms (see separate certificate).\n* The participant rates either moderate distress from physical symptoms on the PHQ-15 questionnaire (over 10 points) or significant distress from a single physical symptom (at least 2 points for that symptom).\n* The participant expresses interest in exploring whether emotional factors, such as stress, may contribute to their symptom profile.\n* Any prescribed medications must have been stable for at least one month.\n\nExclusion Criteria:\n\n* Participants suffer from ongoing substance abuse (alcohol or drugs) or are assessed to have severe mental health issues (psychotic disorders, moderate to high suicide risk, antisocial personality disorder, etc.).\n* Participants are currently prescribed medications that are clearly addictive and sedative in nature (e.g., benzodiazepines).\n* Participants are involved in other psychological treatments focused on physical symptoms. However, other psychological treatments are permitted as long as the supportive therapy does not occur more than once a month.\n* Participants do not have sufficient proficiency in the Swedish language.\n\nPlease note that it is the chief physician of each respective research sponsor who, based on collected anamnesis and self-assessment information, makes the final decision regarding whether a participant should be included or excluded from the research project.",{"count":155,"type":20},50,[23],"Emotional Awareness and Expression Therapy (EAET) has emerged as a promising approach for addressing persistent physical symptoms (PPS). Investigating EAET within the context of routine psychiatric care is crucial for several reasons:\n\nMany patients with PPS experience significant distress and functional impairment, yet traditional medical treatments often fail to provide adequate relief. Integrating EAET into routine care could offer a valuable therapeutic option for this population.\n\nPreliminary studies suggest that EAET can lead to significant reductions in pain and other somatic symptoms. Investigating its effectiveness in routine care settings could enhance treatment outcomes for patients who have not responded to conventional therapies.\n\nThere is often a disconnect between mental health and physical health treatment in routine care. Investigating EAET can help bridge this gap, fostering collaboration between mental health professionals and primary care providers to address the complexities of patients\\' health issues.",[159,160,161,26],"Persistent Physical Symptoms (PPS)","Functional Somatic Disorder","Functional Somatic Syndromes",[163,164,165],"Emotional Awareness and Expression Therapy","Group psychotherapy","routine care","2024-10-07",{"date":168,"type":42},"2024-10-08",{"date":170,"type":20},"2024-11-01",{"date":172,"type":20},"2025-12-31",{"name":174,"class":49},"Daniel Maroti"]