Complex Post-Traumatic Stress Disorder (CPTSD)NCT07863089
RECONNECT - Treatments for Complex PTSD
A study testing Prolonged Exposure, EMDR and ESTAIR in people with Complex Post-Traumatic Stress Disorder (CPTSD), run by University of Copenhagen.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complex Post-Traumatic Stress Disorder (CPTSD)
- What is being tested?
- Prolonged Exposure, EMDR and ESTAIR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2027to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- concurrent psychotherapy
- changed dosage on psychotropic medication
- not fluent in Danish
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
Although 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.
Interventions
Prolonged 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.
Eye 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.
Enhanced 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.
### Objectives
The primary objective is to compare the effectiveness of individual PE, EMDR, and ESTAIR among adult psychiatric outpatients with a primary diagnosis of CPTSD.
The 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.
Hypothesis
The 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.
Study Design
RECONNECT 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.
Participants will be randomly allocated in equal proportions to one of three individual psychological treatments:
- Prolonged Exposure (PE)
- Eye Movement Desensitization and Reprocessing (EMDR)
- Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR)
Each 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.
- Being tested
- Prolonged Exposure, EMDR, ESTAIR
- Keywords
- Psychotherapy, Prolonged Exposure, EMDR, ESTAIR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged ExposureBehavioural
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
EMDRBehavioural
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
ESTAIRBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Prolonged Exposure |
| 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. Receives: Behavioral: EMDR |
| Enhanced Skills Training in Affective and Interpersonal Regulation | Experimental | 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. Receives: Behavioral: ESTAIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
The scale ranges from 0 to 24 for PTSD symptoms and 0 to 24 for DSO symptoms, with higher scores reflecting greater symptom severity.
Measured: From enrollment to 28 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start31 Jul 2027 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Post-Traumatic Stress Disorder (CPTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863089
- Sponsor's protocol ID
- H-26024063
- Other IDs
- 5331-00026B
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data cannot be shared publicly because our dataset involves subjects who did not explicitly consent to the publication of their pseudonymized data with is required to comply with the Danish Data Protection Act. Therefore, publishing the dataset does not align with the ethical standards of data management and regulations upheld at the University of Copenhagen. Data are available from the Data Management and Information Security department at the Department of Psychology, University of Copenhagen (contact via legal@samf.ku.dk) for researchers who meet the criteria for access to confidential data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECONNECT - Treatments for Complex PTSD
- ClinicalTrials.gov ID
- NCT07863089
- Acronym / sponsor ID
- H-26024063
- Keywords
- Psychotherapy, Prolonged Exposure, EMDR, ESTAIR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 31 Jul 2027 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Although 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.
Interventions
Prolonged 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.
Eye 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.
Enhanced 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.
### Objectives
The primary objective is to compare the effectiveness of individual PE, EMDR, and ESTAIR among adult psychiatric outpatients with a primary diagnosis of CPTSD.
The 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.
Hypothesis
The 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.
Study Design
RECONNECT 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.
Participants will be randomly allocated in equal proportions to one of three individual psychological treatments:
- Prolonged Exposure (PE)
- Eye Movement Desensitization and Reprocessing (EMDR)
- Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR)
Each 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure | Active comparator | Behavioral: Prolonged ExposurePE 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). |
| Eye Movement Desensitization and Reprocessing | Experimental | Behavioral: EMDREMDR 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. |
| Enhanced Skills Training in Affective and Interpersonal Regulation | Experimental | Behavioral: ESTAIRESTAIR 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- concurrent psychotherapy
- changed dosage on psychotropic medication
- not fluent in Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged ExposureAll 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 | Behavioural | Prolonged Exposure |
| EMDRAll 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 | Behavioural | Eye Movement Desensitization and Reprocessing |
| ESTAIRAll 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 | Behavioural | Enhanced Skills Training in Affective and Interpersonal Regulation |
Primary outcome
International Trauma Questionnaire
Time frame: From enrollment to 28 weeks post intervention
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"). The scale ranges from 0 to 24 for PTSD symptoms and 0 to 24 for DSO symptoms, with higher scores reflecting greater symptom severity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. Data cannot be shared publicly because our dataset involves subjects who did not explicitly consent to the publication of their pseudonymized data with is required to comply with the Danish Data Protection Act. Therefore, publishing the dataset does not align with the ethical standards of data management and regulations upheld at the University of Copenhagen. Data are available from the Data Management and Information Security department at the Department of Psychology, University of Copenhagen (contact via legal@samf.ku.dk) for researchers who meet the criteria for access to confidential data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure, EMDR and ESTAIR in people with Complex Post-Traumatic Stress Disorder (CPTSD), run by University of Copenhagen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Kerstine Kaya Nielsen, Assistant Professor, PhD (0045 35324542, sara.nielsen@psy.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Trauma Questionnaire (time frame: From enrollment to 28 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.