[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adjustment-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adjustment-disorders":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,64,88,114,149],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100474291","phase-2-mdma-assisted-therapy-for-stress-disorders-in-healthcare-workers-and-first-responders-100474291",false,"NCT05455996","MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First Responders","An Open Label Study to Treat Post-Traumatic Stress in Frontline Healthcare Workers and First Responders Using MDMA-Assisted Therapy","Inclusion Criteria:\n\n* Were exposed to stressors related to their work in a health care setting or emergency response system\n* Are fluent in speaking and reading English.\n* Are able to swallow pills.\n* Agree to have study visits recorded, including Experimental Sessions, and non-drug therapy sessions.\n* Have a contact (relative, spouse, close friend or other Support Person) who is willing and able to be reached by the Sponsor-Investigators in the event of a participant becoming suicidal or unreachable.\n* Agree to inform the Sponsor-Investigators within 48 hours of any medical conditions and procedures.\n* If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.\n* Comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, be driven home after Experimental Sessions, and commit to medication dosing, therapy, and study procedures.\n\nExclusion Criteria:\n\n* Have previously participated in a clinical treatment trial using MDMA.\n* Have a past diagnosis of PTSD unrelated to their work in the healthcare or emergency response systems.\n* Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.\n* Have a history of or a current primary psychotic disorder or bipolar I disorder\n* Have a current eating disorder with active purging\n* Have current major depressive disorder with psychotic features\n* Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate\n* Have uncontrolled essential hypertension\n* Have a history of ventricular arrhythmia at any time, other than premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n* Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n* Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.\n* Have a marked Baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\>450 milliseconds \\[ms\\] in males and \\>460 ms in females corrected by Fridericia's formula).\n* Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n* Require use of concomitant medications that prolong the QT\u002FQTc interval during Experimental Sessions.\n* Have symptomatic liver disease or have significant liver enzyme elevations.\n* Have a history of hyponatremia or hyperthermia.\n* Weigh less than 48 kilograms (kg).\n* Are pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Frontline Health Care Workers and First Responders suffering from symptoms of Post-Traumatic Stress.",[26,27],"Post-Traumatic Stress Disorder","Adjustment Disorders","NOT_YET_RECRUITING","2026-04-30",{"date":31,"type":32},"2026-05-05","ACTUAL",{"date":34,"type":20},"2026-10",{"date":36,"type":20},"2028-06",{"name":38,"class":39},"Nautilus Sanctuary","OTHER",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":63},"100484191","phase-2-mdma-assisted-therapy-for-adjustment-disorder-ad-in-dyads-of-patients-with-cancer-and-a-concerned-significant-other-100484191","NCT05584826","MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other","Inclusion Criteria:\n\n1. Are at least 18 years old\n2. Are considered important to their well-being by patient participants (e.g., spouse or close family member)\n3. Meet DSM-5 criteria for current AD (no criteria for another mental disorder and does not correspond to an exacerbation of a preexisting mental disorder. Does not represent a normal bereavement)\n4. Satisfies diagnostic criteria for AD using the ADNM-2020 (score ≥ 47.5 on the scale)\n5. Are able to swallow pills.\n6. Are willing to be driven home after the experimental sessions, either by a driver arranged by the participant or by the site personnel or taxi and agree not to drive after each Experimental Session until the therapists deem it safe to do so\n7. If able to become pregnant (i.e. assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).\n8. Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures\n9. Are proficient in speaking and reading English\n10. Agree to have all clinic visit sessions recorded to audio and video\n11. Agree to the following lifestyle modifications (described in more detail in Section 4.3 Lifestyle Modifications): comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not enroll in any other interventional clinical trials during the duration of the study, be driven home after each Experimental Session, and commit to medication dosing, therapy, and study procedures.\n12. May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.\n13. May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.\n14. May have alcohol or substance use disorder if participant is not in withdrawal or requiring detox. Participants must have a plan, agreed upon by investigator, therapy team, and study physician, to reduce use of alcohol or other substances and to manage symptoms without self-medicating. Enrollment will require that, in the judgment of the investigator, therapy team, and study physician, the plan for decreasing substance use is realistic and has a good chance of succeeding in order to prevent substance use from impacting the safety or efficacy of the investigational treatment.\n15. May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the study physician.\n16. May have hypothyroidism if taking adequate and stable thyroid replacement medication.\n17. May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.\n\nExclusion Criteria:\n\n1. Concurrent or recent (less than four weeks) cytotoxic chemotherapy or radiation therapy, that impairs general level of physical functioning (index participant)\n2. Weigh less than 48 kg\n3. Condition impairing oral intake or digestive absorption\n4. Are not able to give adequate informed consent\n5. Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 6 months or at V0 (see Appendix A)\n6. Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation\n7. Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.\n8. Have a history of, or a current primary psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1 or history of or current dissociative identity disorder\n9. Require ongoing concomitant therapy with a psychiatric medication with exceptions described in Section 8.0: Concomitant Medications.\n10. Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.\n11. Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session;\n12. Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n13. Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n14. Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.\n\n    Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs, and confirmed by a cardiologist.\n15. Have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration (participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded). Note: if participants present with a history of glaucoma, enrollment would be allowed only with the approval of their ophthalmologist\n16. Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140\u002F90 milligrams of Mercury \\[mmHg\\] or higher assessed on three separate occasions)\n17. Have a heart rate \\> 100 bpm on three separate occasions\n18. Have a marked Baseline prolongation of QT\u002FQTc interval (For purposes of eligibility, this is defined as repeated demonstration of a QT interval corrected using Fridericia's formula \\[QTcF\\] \\>450 milliseconds \\[ms\\] and \\>460 ms in females. For transgender or non-binary participants, QTc interval will be evaluated based on sex assigned at birth, unless the participant has been on hormonal treatment for five or more years.\n19. Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n20. Require use of concomitant medications that prolong the QT\u002FQTc interval during Experimental Sessions. Refer to Section 12.0 Concomitant Medications.\n21. Have symptomatic liver disease\n22. Have history of hyponatremia or hyperthermia\n23. Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control.\n24. Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).",{"count":48,"type":20},20,[23],"The goal of this clinical trial is to assess feasibility, tolerability and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in 10 dyads of patients with cancer and a concerned significant other (CSO) (20 participants total).\n\nParticipants will undergo an 8-week treatment period which will include two doses of MDMA, two Preparatory Sessions and four Integrative Sessions of non-drug therapy.",[52,27],"Cancer","RECRUITING","2026-04-28",{"date":56,"type":32},"2026-05-04",{"date":58,"type":32},"2022-10-06",{"date":60,"type":20},"2028-11",{"name":62,"class":39},"Sunstone Medical",1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":40},"100584147","adjustment-disorders-in-the-us-military-disease-trajectories-and-adnm-20-mil-validation-100584147","NCT06885554","Adjustment Disorders in the US Military: Disease Trajectories and ADNM-20-Mil Validation","Inclusion Criteria:\n\n* Age 18-64\n* Serving as active duty in the US Military\n* Diagnosed with adjustment disorder (with or without depression and\u002For anxiety) within the last 3 months\n* No other mental health diagnosis (e.g., schizophrenia spectrum and other psychotic disorders, substance use disorder, bipolar and related disorders, TBI)\n* No current thoughts of or serious risk of suicide\n* Willing and available (e.g., no upcoming deployments or station changes within the next 6 months) to be participate in all study activities if eligible and enrolled\n* Any psychotropic drug therapy regimen must be stable (unchanging) for at least 4 weeks prior to enrollment and remain steady throughout the study\n* Must have and be willing to use an internet-enabled smartphone or tablet for the study\n* Provision of appropriate storage and charging for study equipment in a generally safe and dry condition\n* In treatment through the Military Health System for adjustment disorder\n\nExclusion Criteria:\n\n* Significant medical conditions or other circumstances which would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the patient from safely participating in study.\n* Does not meet the eligibility criteria\n* Unable to read, speak, or comprehend English\n* Unable or unwilling to give informed consent\n* No current pregnancy or intention\u002Fplanned pregnancy during study duration, or lactation\n* Study participants of childbearing potential who are unwilling to use an effective method of contraception during the use of SANA device\n* History or presence of photo-sensitive epilepsy or other photo-sensitive condition\n* History or presence of condition(s) that may affect balance, such as seizure disorders or vertigo\n* History or presence of severe and continuous tinnitus\n* History or presence of migraine headaches\n* Surgery or trauma requiring rehabilitation within the last 12 weeks\n* Presence of cancer pain, acute pain following injury or other severe pain that would be anticipated to change during the course of the study\n* Vision impairments that affect perception of light, color, or brightness in one or both eyes, and differences in visual perception between eyes\n* Deafness in one or both ears, perceived differences in hearing between ears\n* Current ear or eye infection, untreated allergies, or acute illness that may affect eyes or hearing (e.g., due to congestion)\n* Presence of inflammation or broken skin around the eyes in the area of the mask\n* Presence of narcolepsy or untreated sleep apnea. Note: presence of sleep apnea is permitted, so long as patients feel comfortable to use both apnea mask and Sana device in conjunction.\n* Participation in any other clinical study in which medication(s) are being delivered or have used an investigational drug or device within the last 30 days.\n* Current thoughts of suicide","64 Years",{"count":72,"type":20},60,[74],"NA","Adjustment disorders (AjDs) - a group of mental health diagnosis given following exposure to a stressor that results in preoccupation, failure to adapt, and\u002For functional impairments - have consistently remained the most common mental health diagnoses in the US military across branches for more than a decade. AjDs can be dangerous and negatively affect military readiness by reducing availability of members and through use of resources to allow evacuations from combat. Diagnosing AjDs can be challenging as it is closely related to other well-defined mental health disorders and assessment and research on AjDs have historically been difficult due to the lack of clarity in the disorder's diagnostic criteria. However, the Adjustment Disorder New Module (ADNM-20) is a recently developed instrument that has shown promise.\n\nIn previous work, our team adapted the ADNM-20 to the US military population after finding that there was a need for an AjD-specific diagnostic instrument in this population; this instrument is referred to as the ADNM-20-Mil. The principal focus of this study is the longitudinal psychometric validation of the ADNM-20-mil. However, another goal of the proposed study is to pilot test the audio-visual stimulation device SANA for AjD as pilot testing such a device for AjD is a needed next step. Furthermore, the proposed, longitudinal study provides an ideal platform to test the ADNM-20-Mil's sensitivity to change in the context of this pilot trial to address this critical area of need.",[27],[27,78],"Military","2025-11-18",{"date":81,"type":32},"2025-11-21",{"date":83,"type":32},"2025-10-06",{"date":85,"type":20},"2028-01-01",{"name":87,"class":39},"Henry M. Jackson Foundation for the Advancement of Military Medicine",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":5},"100580879","phase-4-efficacy-and-safety-of-ranquilon-in-patients-with-anxiety-disorders-due-to-neurasthenia-and-adjustment-disorders-100580879","NCT06843044","Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders","An Open-label, Comparative, Randomized, Multicenter Phase IV Clinical Study to Evaluate the Clinical Efficacy and Safety of the Drug Ranquilon, Tablets, 1 mg, in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders","Inclusion Criteria:\n\n1. Males and females aged 18 to 70 years;\n2. Written informed consent form in accordance with current legislation;\n3. Patients with anxiety and established diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2);\n4. Anxiety severity on the HARS scale of 18-24 points;\n5. Assessment of the severity of suicidal thoughts using the Columbia scale \\\u003C3 points;\n6. Severity of asthenia on the Multidimensional Fatigue Inventory Scale (MFI-20) greater than 50 points;\n7. Total score on the Hamilton Depression Rating Scale (HAMD-17) \\\u003C 6;\n8. Score on the CGI-s scale of at least 4 points;\n9. Negative pregnancy test for women of childbearing potential;\n10. Agreement to use effective contraceptive methods throughout the study and for 30 days after its completion (for women of childbearing potential and men);\n11. Ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of health-related information), and comply with the procedures outlined in the study protocol.\n\nNon-inclusion Criteria:\n\n1. Known intolerance to the active and\u002For excipient substances contained in the study drugs;\n2. Known lactase deficiency, lactose intolerance, glucose-galactose malabsorption, or galactose intolerance;\n3. Patients requiring prohibited concomitant therapy within this study (MAO inhibitors, antidepressants, neuroleptics, anxiolytics and sedatives (including herbal), hypnotics when used on a regular basis), or who have taken these medications within the last month;\n4. Established or suspected alcohol\u002Fnarcotic substance use at the time of screening or randomization, and\u002For a history of alcohol, narcotic, or drug dependence;\n5. Presence of oncological diseases, including in history (except for cured tumors with stable remission for more than 5 years);\n6. Tuberculosis, including in history;\n7. Presence of HIV, chronic viral hepatitis B\u002FC, syphilis (including past history), or a positive test for HIV, hepatitis B\u002FC, or syphilis at screening;\n8. Patients with a diagnosis of other anxiety disorders (F41) established based on ICD-10 criteria;\n9. Schizophrenia, schizoaffective disorders, affective disorders, and panic disorders;\n10. Acute psychosis (endogenous-processual, organic, or somatogenic), including in history;\n11. Organic lesions of the central nervous system of traumatic and alcoholic origin;\n12. Post-encephalitic syndrome;\n13. History of brain tumors (including past diagnoses);\n14. Degenerative diseases of the central nervous system (CNS), particularly multiple sclerosis;\n15. History of depression (including past episodes);\n16. Suicide attempts in history;\n17. Generalized anxiety disorder, including in history;\n18. History of epilepsy and seizures (including past episodes);\n19. Decompensated diabetes mellitus;\n20. Established diagnosis of chronic kidney disease stage 3A and above, or estimated glomerular filtration rate (eGFR) calculated by the Cockcroft-Gault formula ≤ 59 ml\u002Fmin\u002F1.73 m²;\n21. Established diagnosis of liver failure of any severity, or elevated levels of ALT, AST or total bilirubin \\>3 times the upper limit of normal according to laboratory standards;\n22. History of major surgical interventions within six months prior to screening;\n23. Chronic heart failure III-IV functional class according to the New York Heart Association (NYHA) classification;\n24. Severe, decompensated, or unstable diseases (any diseases or conditions that poses a life-threatening risk to the patient, worsens the patient's prognosis, or makes participation in the clinical study impossible);\n25. Pregnant women, breastfeeding women, or women planning to become pregnant during the study or within 30 days after participation ends;\n26. Refusal by the patient to use permitted methods of contraception or to completely abstain from sexual contact throughout the entire period of participation in the study starting from Visit 0 and for 30 days after completion of participation;\n27. Current participation or planned participation by the patient in psychological or psychotherapeutic activities aimed at treating anxiety disorder during the clinical trial period;\n28. Participation in any other clinical trial within 90 days prior to the start of the screening period;\n29. Lack of patient cooperation;\n30. Other reasons, at the investigator's discretion, that may hinder the patient's participation in the study or pose unjustified risk to the patient.\n\nExclusion Criteria:\n\n1. The patient's decision to withdraw from the study (revocation of informed consent);\n2. Each patient has the right to discontinue participation in the study at any time without explanation. Withdrawal from the study will not affect the medical care provided to the patient in the future;\n3. The investigator's decision that the patient needs to be excluded in the best interest of the patient;\n4. The patient refuses to cooperate with the investigator or is non-compliant;\n5. Emergence of reasons\u002Fsituations during the study that threaten the patient's safety (e.g., hypersensitivity reactions, serious adverse events, etc.);\n6. Inclusion of a patient in the study that does not meet the inclusion\u002Fexclusion criteria, including cases of deviation from normal values in laboratory test results obtained at Visit 0;\n7. Significant violation of the treatment regimen.\n\n   A significant violation is considered:\n   1. Missing doses of the study drugs for 2 consecutive days or more, or\n   2. Taking a total number of tablets \\\u003C 80% or \\> 120% of the full course (the full course for Ranquilon is 168 tablets, and for Afobazole, it is 84 tablets).\n8. Positive pregnancy test;\n9. Confirmed diagnosis of COVID-19;\n10. Emergence of other reasons during the study that prevent its conduct according to the protocol;\n11. Patient death;\n12. Sponsor-initiated study termination;\n13. Termination of the study by the Investigator;\n14. Termination of the study by regulatory authorities.","70 Years",{"count":97,"type":20},250,[99],"PHASE4","Study is to evaluate the efficacy and safety of the drug Ranquilon, 1 mg tablets, at a dosage of 6 mg\u002Fday compared to the drug Afobazole, 10 mg tablets, at a dosage of 30 mg\u002Fday for the treatment of patients with anxiety disorders due to neurasthenia and adjustment disorders.",[102,103,27],"Anxiety","Neurasthenia","2025-07-02",{"date":106,"type":32},"2025-07-08",{"date":108,"type":32},"2025-01-13",{"date":110,"type":20},"2027-12-31",{"name":112,"class":113},"Valenta Pharm JSC","INDUSTRY",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100431588","evaluation-of-primary-care-behavioral-health-pcbh-with-the-addition-of-self-help-cbt---a-randomized-multicenter-trial-100431588","NCT04900064","Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial","Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial for Superiority and Non-superiority Comparisons of Effects on Patients' Everyday Function, Symptoms, and Experiences","KAIROS","Inclusion Criteria:\n\n* All patients from age 18 who seek care at the PCC, who are deemed to be suitable for Behavioural Health interventions and booked to the mental health professionals at the PCC, according to screening methods and\u002For clinical assessments made by health care personnel at the PCC, will be included. This broad criteria reflects the naturalistic setting where decisions of clinicians, rather than highly standardized criteria, are the basis for inclusion.\n\nExclusion Criteria:\n\n* Does not speak Swedish well enough to fill out questionnaires or to receive self-help CBT in Swedish.\n* Is in need of emergency type care, like with suicidal ideation or behaviours, ongoing psychosis or mania.",{"count":123,"type":20},1242,[74],"In this multicenter study, the investigators want to find out if an addition of an diagnostic assessment and possibility of treatment with guided self-help CBT can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH which uses contextual assessment and brief interventions. In addition to this, the study will investigate the overall effect of PCBH on both patient and organisation level outcomes.",[127,128,129,130,131,132,133,27,134,135,136,137,138],"Panic Disorder","Social Anxiety Disorder","Depression","Hypochondriasis","Insomnia","Generalized Anxiety Disorder","Burnout","Stress, Psychological","Obsessive-Compulsive Disorder","Life Stress","Life Style Induced Illness","Psychological Distress","2025-04-08",{"date":141,"type":32},"2025-04-11",{"date":143,"type":32},"2021-06-14",{"date":145,"type":20},"2026-12-31",{"name":147,"class":39},"Linnaeus University",4,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":63},"100549381","transdiagnostic-behavior-therapy-vs-tau-for-adjustment-disorder-following-traumatic-event-exposure-100549381","NCT06433271","Transdiagnostic Behavior Therapy Vs TAU for Adjustment Disorder Following Traumatic Event Exposure","Comparative Effectiveness of Transdiagnostic Behavior Therapy Vs TAU for Adjustment Disorder Following Traumatic Event Exposure","Inclusion Criteria:\n\n* Adult male or female over the age of 18 that has served, or is currently serving, in the military.\n* Stable psychotropic medication for at least 4 weeks if applicable\n* Current DSM-5 diagnosis of Adjustment Disorder\n\nExclusion Criteria:\n\n* Active psychosis\n* Suicidal ideation with clear intent\n* Severe substance use",{"count":157,"type":20},150,[74],"Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials. This study seeks to build on the research team's pilot work across several disorders study to benefit service members and Veterans with AjD, a highly prevalent but frequently inadequately treated condition.\n\nThe investigators will compare the effects of Transdiagnostic Behavior Therapy (TBT) vs treatment as usual which is Moving Forward Problem Solving Therapy (TAU-PST) on AjD symptom outcomes. The investigators hypothesize that TBT will result in greater overall symptom reduction compared to TAU-PST.",[27,161],"Mental Disorder",[163,164],"Veterans","Military Personnel","2024-12-03",{"date":167,"type":32},"2024-12-06",{"date":169,"type":32},"2024-10-08",{"date":171,"type":20},"2029-01",{"name":173,"class":39},"The University of Texas Health Science Center, Houston"]