[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659344":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":22,"studyPopulation":13,"armGroups":23,"interventions":41,"overallOfficials":13,"centralContacts":52,"locations":13,"responsibleParty":58,"collaborators":13,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":13,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":13,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":80,"whyStopped":13,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":13},{"fullName":5,"class":6},"University of Copenhagen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"International Trauma Questionnaire","Self-report measuring CPTSD symptoms, with 18-items assessing for ICD-11 PTSD and complex PTSD (CPTSD). Respondents are asked to identify \"the experience that troubles you the most\" along with how long ago it occurred. Then they are asked to respond to symptom and functioning questions. Items are rated on a 5-point scale ranging from 0 (\"not at all\") to 4 (\"extremely\").\n\nThe scale ranges from 0 to 24 for PTSD symptoms and 0 to 24 for DSO symptoms, with higher scores reflecting greater symptom severity.","From enrollment to 28 weeks post intervention",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"SINGLE",[21],"OUTCOMES_ASSESSOR","Complex post-traumatic stress disorder (CPTSD) was introduced as a distinct diagnosis in the 11th revision of the International Classification of Diseases (ICD-11). CPTSD includes the core symptoms of post-traumatic stress disorder (PTSD)-re-experiencing, avoidance, and a persistent sense of current threat-as well as disturbances in self-organization (DSO). DSO symptoms comprise affective dysregulation, negative self-concept, and difficulties in relationships. CPTSD is frequently associated with prolonged or repeated trauma and may involve substantial functional impairment, dissociation, interpersonal difficulties, self-harm, and an increased risk of suicide.\n\nAlthough CPTSD is associated with considerable clinical burden, evidence regarding its optimal treatment remains limited. No single psychological treatment has been established as the preferred evidence-based intervention for all patients with CPTSD. The heterogeneity of CPTSD also suggests that treatment response may vary according to patients' clinical characteristics. Research is therefore needed both to compare potentially effective treatments and to identify factors that may inform future treatment selection.\n\nInterventions\n\nProlonged Exposure (PE) is an established trauma-focused psychological treatment for PTSD and is recommended in international clinical guidelines. However, evidence regarding its effectiveness specifically for CPTSD remains limited.\n\nEye Movement Desensitization and Reprocessing (EMDR) is also recommended for PTSD and has shown promising results among patients with complex trauma presentations, including dissociative symptoms and trauma related to sexual abuse. Preliminary studies indicate that EMDR may also be effective for CPTSD.\n\nEnhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) was developed specifically for CPTSD. It is a modular treatment comprising four components that address PTSD symptoms, emotion regulation, negative self-concept, and interpersonal difficulties. The modular structure allows the clinician and patient to determine the order and emphasis of the treatment components according to the patient's needs.\n\n\\### Objectives\n\nThe primary objective is to compare the effectiveness of individual PE, EMDR, and ESTAIR among adult psychiatric outpatients with a primary diagnosis of CPTSD.\n\nThe primary outcome is CPTSD symptom severity. Secondary outcomes include quality of life, dissociation, interpersonal difficulties, and emotion-regulation difficulties. The study will also explore whether baseline patient characteristics predict treatment outcomes or moderate the comparative effects of the three interventions.\n\nHypothesis\n\nThe primary hypothesis is that ESTAIR and EMDR will each be non-inferior to PE, which represents treatment as usual, in reducing CPTSD symptoms. CPTSD symptoms are measured using the International Trauma Questionnaire (ITQ) from baseline to post-treatment and at the 6-month follow-up. The predefined non-inferiority margin is 6 points on the ITQ.\n\nStudy Design\n\nRECONNECT is an investigator-initiated, multicenter, randomized, assessor-blinded, three-arm, non-inferiority clinical trial. A total of 315 adults aged 18-65 years with a primary diagnosis of CPTSD will be recruited from three outpatient clinics within the Danish Mental Health Services.\n\nParticipants will be randomly allocated in equal proportions to one of three individual psychological treatments:\n\n* Prolonged Exposure (PE)\n* Eye Movement Desensitization and Reprocessing (EMDR)\n* Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR)\n\nEach intervention consists of 18 weekly individual sessions lasting approximately 60 minutes. Outcomes will be assessed at baseline, during treatment, immediately after treatment, and at follow-up. Outcome assessors will be blinded to treatment allocation.",[24,30,36],{"label":25,"type":26,"description":27,"interventionNames":28},"Prolonged Exposure","ACTIVE_COMPARATOR","PE is a manualized, trauma-focused exposure therapy aimed at facilitating emotional processing of traumatic memories. In this study, PE is delivered over 18 sessions and includes three core components: (1) psychoeducation about trauma and PTSD, including a rationale for exposure-based treatment and the role of avoidance and maladaptive beliefs in maintaining symptoms; (2) in vivo exposure, involving repeated and graded confrontation with objectively safe but trauma-related situations, typically conducted as homework; and (3) imaginal exposure, in which patients repeatedly recount the traumatic memory aloud in session, followed by therapeutic processing and between-session listening to audio recordings. Through repeated exposure, PE seeks to modify maladaptive beliefs and reduce symptoms by enabling patients to integrate corrective information and process trauma-related distress (McLean \\& Foa, 2011).",[29],"Behavioral: Prolonged Exposure",{"label":31,"type":32,"description":33,"interventionNames":34},"Eye Movement Desensitization and Reprocessing","EXPERIMENTAL","EMDR is an eight-phase, trauma-focused psychotherapy designed to facilitate the processing of distressing memories. In this study, EMDR is delivered over 18 sessions. Core elements include focusing on emotionally salient aspects of traumatic memories while engaging in bilateral stimulation (e.g., eye movements, sounds, or tapping), with brief feedback provided between stimulation sets to monitor processing. This process is repeated until the memory no longer elicits distress. The eight phases encompass history-taking, preparation, assessment, reprocessing, closure, and re-evaluation. EMDR follows a three-pronged approach targeting past experiences, present triggers, and future templates, aiming to promote adaptive resolution reflected in changes in emotions, cognitions, somatic responses, and behavior (F. Shapiro, 1995; F. Shapiro \\& Maxfield, 2002). In our trial we use the Standard EMDR Protocol (E. Shapiro \\& Laub, 2014) with Developmental sensitive interventions.",[35],"Behavioral: EMDR",{"label":37,"type":32,"description":38,"interventionNames":39},"Enhanced Skills Training in Affective and Interpersonal Regulation","ESTAIR is a modular, manualized treatment for CPTSD, delivered in 18 sessions in this study. It includes an initial case formulation followed by four modules: (1) affect regulation, targeting identification and modulation of emotions, distress tolerance, and acceptance; (2) disturbances in relationships, focusing on maladaptive schemas, assertiveness, and interpersonal flexibility; (3) negative self-concept, including self-narrative, addressing dissociation, self-compassion, mindfulness, and cognitive restructuring; and (4) PTSD, involving trauma memory processing through verbal narration and cognitive reappraisal, targeting core PTSD symptoms.",[40],"Behavioral: ESTAIR",[42,46,49],{"type":43,"name":25,"description":44,"armGroupLabels":45,"otherNames":13},"BEHAVIORAL","All treatments are delivered as 18 weekly, individual, 1-hour sessions by trauma clinicians (psychologists and psychiatrists), who will be trained and certified in all three interventions at the beginning of the project. To ensure treatment quality and adherence to the manuals, clinicians will receive bi-weekly video-based group supervision in the first year and then titrated to monthly in the second year and onwards. All three arms follow the same outpatient-clinic guidelines: 1) treatment must be offered within 30 days of referral; 2) treatment duration is 18 weeks; 3) treatment is discontinued if a patient misses four sessions. Each arm will be trained and supervised by a specialist in that treatment: the EMDR-arm by EMDR specialist Sophie Hallin Iuel-Brockdorff; the ESTAIR arm by Prof. Marylene Cloitre, who developed the intervention; and the PE-arm by PE-specialist Sandra Capaldi, a member of the late Prof. Edna Foa's team. Although PE serves as TAU, we have matched the clinical t",[25],{"type":43,"name":47,"description":44,"armGroupLabels":48,"otherNames":13},"EMDR",[31],{"type":43,"name":50,"description":44,"armGroupLabels":51,"otherNames":13},"ESTAIR",[37],[53],{"name":54,"role":55,"phone":56,"phoneExt":13,"email":57},"Sara Kerstine Kaya Nielsen, Assistant Professor, PhD","CONTACT","0045 35324542","sara.nielsen@psy.ku.dk",{"type":59,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659344","reconnect---treatments-for-complex-ptsd-100659344",false,"NCT07863089","RECONNECT - Treatments for Complex PTSD","Inclusion Criteria:\n\na) CPTSD as the primary diagnosis (ICD-11 code 6B41) measured with International Trauma Questionnaire ((ITQ) Cloitre et al., 2021); b) age 18-65; c) no alcohol or substance abuse; d) no concurrent psychotherapy; e) medication free or stable on psychotropic medication for at least five weeks; f) fluency in Danish; and g) written informed consent.\n\nExclusion Criteria:\n\n1. concurrent psychotherapy\n2. changed dosage on psychotropic medication\n3. not fluent in Danish","ALL","18 Years","65 Years",{"count":70,"type":71},225,"ESTIMATED","INTERVENTIONAL",[74],"NA","Complex PTSD (CPTSD) is a new diagnosis for which no established gold-standard treatment(s) yet exists. In this trial, three psychotherapies, Prolonged Exposure (PE), Eye Movement Desensitization and Reprocessing (EMDR), and Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR), are compared in a multisite trial. Methods: The study is a single-blinded, pragmatic, non-inferiority, multi-center randomized controlled trial (RCT) comparing ESTAIR, EMDR vs PE for CPTSD, each delivered as 18 weekly individual sessions. In total, 315 patients will be recruited from three outpatient clinics in the Capital Region of Denmark and randomized to one of the three intervention arms. The primary outcome is patient-rated CPTSD symptoms assessed with the International Trauma Questionnaire (ITQ); secondary outcomes include clinician-rated CPTSD symptoms assessed with the International Trauma interview (ITI), as well as dissociation, quality of life, attachment, interpersonal problems, and emotion regulation. Assessments are conducted before and after therapy (18 weekly sessions) treatment and at 6-month follow-up. Weekly patient- and clinician-rated outcomes are collected at every treatment session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, while fidelity assessors will monitor manual adherence.",[77],"Complex Post-Traumatic Stress Disorder (CPTSD)",[79,25,47,50],"Psychotherapy","NOT_YET_RECRUITING","2026-10-01",{"date":83,"type":84},"2026-10-07","ACTUAL",{"date":86,"type":71},"2027-07-31",{"date":88,"type":71},"2029-12-31",{"name":5,"class":6}]