SCHIZOPHRENIA 1 (Disorder)PS-TraumaNCT07242586
PS-Trauma - Development of Trauma Treatment for Patients With Co-morbid Psychotic Disorders and Traumas
A study testing Prolonged Exposure and EMDR in people with SCHIZOPHRENIA 1 (Disorder) and Schizotypal Disorder, run by Nikolai Albert at 1 site in Denmark.
Trial summary
Overview: People with psychotic disorders frequently have a history of traumatic events such as neglect, bullying, or physical and sexual abuse. Many experience significant symptoms of post-traumatic stress, but trauma-focused treatment is rarely offered in standard psychiatric care. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder), Schizotypal Disorder, Post Traumatic Stress Symptoms
- What is being tested?
- Prolonged Exposure and EMDR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Oct 2025to 30 Jun 2026
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- over 18 years of age Diagnosis within schizophrenia spectrum (ICD10 F2X) PTSD symptoms equivalent to above 31 on the PCL-5 Included in Early intervention services (OPUS) Talks and understands Danish
Who cannot join
- Substance or alcohol abuse interfering with the therapy Indication of sever cognitive impairment Changes in antipsychotic treatment within the last month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Centre Copenhagen
Copenhagen, Denmark, 2900
Nikolai Albert, MD, PhD, +45 29925014, nikolai.albert@regionh.dk
Rikke Hilker, MD, PhD, +45 25775745, rikke.hilker@regionh.dk
About this study
Official title: PS-Trauma: Udvikling af Traumebehandling Til Psykiatriske Patienter Med Psykoselidelse - et Pilotstudie.
Overview:
People with psychotic disorders frequently have a history of traumatic events such as neglect, bullying, or physical and sexual abuse. Many experience significant symptoms of post-traumatic stress, but trauma-focused treatment is rarely offered in standard psychiatric care. This pilot study investigates whether two established trauma therapies can be delivered safely and acceptably to young adults with psychotic disorders receiving care in the OPUS early-intervention program.
Read more
Objectives:
The main aim is to evaluate the feasibility and acceptability of two trauma-focused treatments-Prolonged Exposure (PE) and Eye Movement Desensitization and Reprocessing (EMDR)-in patients with psychotic disorders and post-traumatic stress symptoms. The study is not designed to test treatment efficacy but to determine whether a larger randomized controlled trial is practical.
Study Design:
This is a pilot and feasibility study. Twenty OPUS patients with a diagnosis within the schizophrenia spectrum and clinically relevant PTSD symptoms will be randomly assigned to either PE or EMDR. All participants continue their usual OPUS care while attending weekly trauma-focused therapy sessions.
Assessments:
At baseline and follow-up, participants complete clinical interviews and questionnaires assessing trauma symptoms, psychotic symptoms, functioning, well-being, recovery experiences, and possible negative effects. Instruments include the PCL-5, CAPS-5, Mini-TALE, PANSS-6, PSP, WHO-5, Brief INSPIRE-O, NEQ, and CSQ.
Primary Feasibility Outcomes:
Recruitment: At least 80% of the planned sample enrolled within 6 months.
Retention: At least 70% completing ≥12 therapy sessions.
Acceptability: Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ).
Eligibility:
Inclusion:
Age ≥18
Diagnosis within the schizophrenia spectrum (ICD-10: F20-F29)
PTSD symptom score >31 on PCL-5
Current OPUS patient
Sufficient Danish language skills
Exclusion:
Substance use that prevents participation (e.g., attending sessions intoxicated)
Severe cognitive impairment
Recent changes in antipsychotic medication (within 1 month)
Risks and Safety:
Temporary increases in PTSD symptoms may occur when beginning trauma therapy; this pattern is well documented and typically followed by improvement. Previous studies show no higher risk of serious adverse events among patients with psychosis receiving trauma treatment compared with those who do not. Participants are closely monitored, and the study team works in continuous collaboration with OPUS clinicians. If a participant experiences significant clinical deterioration, the therapy can be paused or stopped, and supportive measures will be provided.
Potential Benefits:
Participants may experience a reduction in trauma-related symptoms and gain access to a treatment that is not otherwise routinely offered to patients with psychotic disorders. The study may help improve future care for this underserved population.
Funding:
The study is funded by the Nektar Foundation and conducted at the CORE Research Unit, Mental Health Services Copenhagen.
Read the detailed description
This pilot study evaluates the feasibility, acceptability, and procedural integrity of delivering trauma-focused psychotherapy to individuals with schizophrenia-spectrum disorders who exhibit clinically significant post-traumatic stress symptoms. Although traumatic experiences are common in this population, trauma-focused treatment remains underutilized in routine psychiatric services due to concerns regarding symptom destabilization, insufficient clinician training, and uncertainty about optimal therapeutic approaches. Emerging evidence indicates that established trauma-focused modalities-specifically Prolonged Exposure (PE) and Eye Movement Desensitization and Reprocessing (EMDR)-can be safely delivered in patients with psychosis when accompanied by close clinical monitoring. Nevertheless, feasibility and implementation data in early-intervention settings remain limited.
The present study is designed as a randomized, parallel-group feasibility trial conducted within the OPUS early-intervention program. The overarching aim is to determine whether a larger powered efficacy trial is practicable. The study systematically evaluates recruitment and retention rates, session attendance, intervention fidelity, acceptability, and the logistical compatibility of trauma-focused treatment with existing OPUS care structures. The pilot nature of the study means that statistical analyses are exploratory and focused on estimating parameters needed for the design of a subsequent definitive trial (e.g., variability of symptom change, pre-post correlations, and event rates).
Participants are randomized 1:1 to either PE or EMDR and receive up to 12 weekly individual sessions in addition to standard OPUS treatment. Therapists are certified in the respective modalities and receive protocol-specific supervision to ensure adherence. Treatment progression follows established manuals: PE focuses on imaginal and in-vivo exposure to trauma memories and avoided situations, whereas EMDR employs bilateral stimulation during structured processing of traumatic material. Both approaches incorporate ongoing risk monitoring, review of symptom trajectories, and coordination with OPUS clinicians.
Assessments are conducted at baseline and after treatment completion. Instruments include structured diagnostic interviews for trauma and psychosis, clinician-rated symptom scales, patient-reported outcomes (trauma symptoms, well-being, recovery experience), functioning measures, and standardized adverse-event reporting tools. Particular emphasis is placed on quantifying temporary symptom fluctuations often observed during trauma therapy, documenting any clinically significant deterioration, and evaluating whether such fluctuations differ across treatment arms.
Safety procedures include predetermined criteria for pausing or discontinuing therapy, rapid communication channels with OPUS teams, and access to supportive interventions when needed. Existing evidence suggests that trauma-focused treatment does not increase the risk of psychotic relapse or severe adverse events compared with non-exposed controls; the study therefore aims to replicate and refine these safety observations within the OPUS context.
Feasibility outcomes include: (1) proportion of eligible patients successfully recruited; (2) proportion of participants completing ≥12 sessions; (3) treatment adherence rated through fidelity checklists; (4) participant-reported acceptability and satisfaction; and (5) operational practicality, including therapist burden, integration with OPUS scheduling, and need for additional support structures. These metrics will inform the design parameters for a future multicenter randomized controlled trial.
Overall, this pilot study seeks to generate high-quality feasibility data on the integration of trauma-focused psychotherapy into early-intervention services for individuals with psychotic disorders. Findings will guide the refinement of recruitment strategies, safety procedures, intervention delivery, and outcome assessment protocols to support a subsequent adequately powered trial aimed at evaluating clinical efficacy.
- Being tested
- Prolonged Exposure, EMDR
- Keywords
- First episode psychosis, Trauma, Schizophrenia, psychotherapy, prolonged exposure, EMDR
- Medical subject headings
- Schizotypal Personality Disorder, Wounds and Injuries, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged ExposureBehavioural
Distinguishing Features - Prolonged Exposure (PE) Arm
This intervention is distinguished by its exclusive reliance on systematic, therapist-guided exposure procedures grounded in emotional-processing theory. PE uses structured imaginal and in-vivo exposure to reduce avoidance and fear responses and does not employ bilateral stimulation, cognitive restructuring, or memory-processing elements characteristic of other trauma-focused approaches. The protocol follows a fixed sequence emphasizing habituation and extinction learning, making it operationally and mechanistically distinct from EMDR and from supportive or stabilization-oriented therapies used in similar clinical studies.
EMDRBehavioural
Distinguishing Features - EMDR Arm
This intervention is distinguished by its use of the standardized eight-phase EMDR protocol, which combines brief exposure to trauma memories with bilateral sensory stimulation to facilitate adaptive information processing. EMDR does not require prolonged or repeated imaginal exposure, fear-hierarchy construction, or systematic in-vivo exposure, differentiating it from PE and other exposure-based trauma treatments. Its mechanism centers on accelerating memory reprocessing rather than habituation, and the protocol includes unique components such as cognition rating, desensitization with bilateral stimulation, installation, and body scan procedures.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure | Active comparator | Prolonged Exposure (PE) Arm:
Participants assigned to PE receive up to 12 weekly individual sessions delivered by trained clinicians following the standard PE manual. Treatment focuses on repeated, systematic confrontation with trauma-related memories (imaginal exposure) and avoided situations (in-vivo exposure) to reduce fear, distress, and maladaptive avoidance. Sessions include psychoeducation, breathing retraining, development of an exposure hierarchy, and structured review of homework assignments. Therapists monitor symptom fluctuations closely and coordinate with the OPUS clinical team. PE is provided in addition to participants' usual OPUS care, and all sessions follow predefined safety and fidelity procedures. Receives: Behavioral: Prolonged Exposure |
| EMDR | Active comparator | Eye Movement Desensitization and Reprocessing (EMDR) Arm:
Participants assigned to EMDR receive up to 12 weekly individual sessions delivered by certified EMDR therapists using the standard eight-phase protocol. Treatment targets distressing trauma memories through brief, repeated exposure combined with bilateral stimulation (e.g., eye movements or tactile taps) to facilitate adaptive information processing. Sessions include history taking, identification of target memories, assessment of negative and positive cognitions, desensitization, installation, and body scan procedures. Therapists monitor symptom changes throughout and coordinate with OPUS clinicians as needed. EMDR is provided alongside usual OPUS care, with adherence ensured through protocol-based supervision and fidelity checks. Receives: Behavioral: EMDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recrutment
80% of planed participants will be included within 6 months
Measured: 6 months
Retensionrate
A minimum of 70% of participants will conclude the therapy sessions
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start2 Oct 2025
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCHIZOPHRENIA 1 (Disorder)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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nikolai Albert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nikolai Albert, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Nikolai Albert, Principal investigator, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242586
- Sponsor's protocol ID
- H-25038884
- Acronym
- PS-Trauma
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If accepted the data will be deposited in the Danish National Archives
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PS-Trauma: Udvikling af Traumebehandling Til Psykiatriske Patienter Med Psykoselidelse - et Pilotstudie.
- ClinicalTrials.gov ID
- NCT07242586
- Acronym / sponsor ID
- PS-Trauma / H-25038884
- Keywords
- First episode psychosis, Trauma, Schizophrenia, psychotherapy, prolonged exposure, EMDR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nikolai AlbertUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Nov 2025 (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.
Overview:
People with psychotic disorders frequently have a history of traumatic events such as neglect, bullying, or physical and sexual abuse. Many experience significant symptoms of post-traumatic stress, but trauma-focused treatment is rarely offered in standard psychiatric care. This pilot study investigates whether two established trauma therapies can be delivered safely and acceptably to young adults with psychotic disorders receiving care in the OPUS early-intervention program.
Objectives:
The main aim is to evaluate the feasibility and acceptability of two trauma-focused treatments-Prolonged Exposure (PE) and Eye Movement Desensitization and Reprocessing (EMDR)-in patients with psychotic disorders and post-traumatic stress symptoms. The study is not designed to test treatment efficacy but to determine whether a larger randomized controlled trial is practical.
Study Design:
This is a pilot and feasibility study. Twenty OPUS patients with a diagnosis within the schizophrenia spectrum and clinically relevant PTSD symptoms will be randomly assigned to either PE or EMDR. All participants continue their usual OPUS care while attending weekly trauma-focused therapy sessions.
Assessments:
At baseline and follow-up, participants complete clinical interviews and questionnaires assessing trauma symptoms, psychotic symptoms, functioning, well-being, recovery experiences, and possible negative effects. Instruments include the PCL-5, CAPS-5, Mini-TALE, PANSS-6, PSP, WHO-5, Brief INSPIRE-O, NEQ, and CSQ.
Primary Feasibility Outcomes:
Recruitment: At least 80% of the planned sample enrolled within 6 months.
Retention: At least 70% completing ≥12 therapy sessions.
Acceptability: Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ).
Eligibility:
Inclusion:
Age ≥18
Diagnosis within the schizophrenia spectrum (ICD-10: F20-F29)
PTSD symptom score >31 on PCL-5
Current OPUS patient
Sufficient Danish language skills
Exclusion:
Substance use that prevents participation (e.g., attending sessions intoxicated)
Severe cognitive impairment
Recent changes in antipsychotic medication (within 1 month)
Risks and Safety:
Temporary increases in PTSD symptoms may occur when beginning trauma therapy; this pattern is well documented and typically followed by improvement. Previous studies show no higher risk of serious adverse events among patients with psychosis receiving trauma treatment compared with those who do not. Participants are closely monitored, and the study team works in continuous collaboration with OPUS clinicians. If a participant experiences significant clinical deterioration, the therapy can be paused or stopped, and supportive measures will be provided.
Potential Benefits:
Participants may experience a reduction in trauma-related symptoms and gain access to a treatment that is not otherwise routinely offered to patients with psychotic disorders. The study may help improve future care for this underserved population.
Funding:
The study is funded by the Nektar Foundation and conducted at the CORE Research Unit, Mental Health Services Copenhagen.
Detailed description
This pilot study evaluates the feasibility, acceptability, and procedural integrity of delivering trauma-focused psychotherapy to individuals with schizophrenia-spectrum disorders who exhibit clinically significant post-traumatic stress symptoms. Although traumatic experiences are common in this population, trauma-focused treatment remains underutilized in routine psychiatric services due to concerns regarding symptom destabilization, insufficient clinician training, and uncertainty about optimal therapeutic approaches. Emerging evidence indicates that established trauma-focused modalities-specifically Prolonged Exposure (PE) and Eye Movement Desensitization and Reprocessing (EMDR)-can be safely delivered in patients with psychosis when accompanied by close clinical monitoring. Nevertheless, feasibility and implementation data in early-intervention settings remain limited.
The present study is designed as a randomized, parallel-group feasibility trial conducted within the OPUS early-intervention program. The overarching aim is to determine whether a larger powered efficacy trial is practicable. The study systematically evaluates recruitment and retention rates, session attendance, intervention fidelity, acceptability, and the logistical compatibility of trauma-focused treatment with existing OPUS care structures. The pilot nature of the study means that statistical analyses are exploratory and focused on estimating parameters needed for the design of a subsequent definitive trial (e.g., variability of symptom change, pre-post correlations, and event rates).
Participants are randomized 1:1 to either PE or EMDR and receive up to 12 weekly individual sessions in addition to standard OPUS treatment. Therapists are certified in the respective modalities and receive protocol-specific supervision to ensure adherence. Treatment progression follows established manuals: PE focuses on imaginal and in-vivo exposure to trauma memories and avoided situations, whereas EMDR employs bilateral stimulation during structured processing of traumatic material. Both approaches incorporate ongoing risk monitoring, review of symptom trajectories, and coordination with OPUS clinicians.
Assessments are conducted at baseline and after treatment completion. Instruments include structured diagnostic interviews for trauma and psychosis, clinician-rated symptom scales, patient-reported outcomes (trauma symptoms, well-being, recovery experience), functioning measures, and standardized adverse-event reporting tools. Particular emphasis is placed on quantifying temporary symptom fluctuations often observed during trauma therapy, documenting any clinically significant deterioration, and evaluating whether such fluctuations differ across treatment arms.
Safety procedures include predetermined criteria for pausing or discontinuing therapy, rapid communication channels with OPUS teams, and access to supportive interventions when needed. Existing evidence suggests that trauma-focused treatment does not increase the risk of psychotic relapse or severe adverse events compared with non-exposed controls; the study therefore aims to replicate and refine these safety observations within the OPUS context.
Feasibility outcomes include: (1) proportion of eligible patients successfully recruited; (2) proportion of participants completing ≥12 sessions; (3) treatment adherence rated through fidelity checklists; (4) participant-reported acceptability and satisfaction; and (5) operational practicality, including therapist burden, integration with OPUS scheduling, and need for additional support structures. These metrics will inform the design parameters for a future multicenter randomized controlled trial.
Overall, this pilot study seeks to generate high-quality feasibility data on the integration of trauma-focused psychotherapy into early-intervention services for individuals with psychotic disorders. Findings will guide the refinement of recruitment strategies, safety procedures, intervention delivery, and outcome assessment protocols to support a subsequent adequately powered trial aimed at evaluating clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure | Active comparator | Behavioral: Prolonged ExposureProlonged Exposure (PE) Arm: Participants assigned to PE receive up to 12 weekly individual sessions delivered by trained clinicians following the standard PE manual. Treatment focuses on repeated, systematic confrontation with trauma-related memories (imaginal exposure) and avoided situations (in-vivo exposure) to reduce fear, distress, and maladaptive avoidance. Sessions include psychoeducation, breathing retraining, development of an exposure hierarchy, and structured review of homework assignments. Therapists monitor symptom fluctuations closely and coordinate with the OPUS clinical team. PE is provided in addition to participants' usual OPUS care, and all sessions follow predefined safety and fidelity procedures. |
| EMDR | Active comparator | Behavioral: EMDREye Movement Desensitization and Reprocessing (EMDR) Arm: Participants assigned to EMDR receive up to 12 weekly individual sessions delivered by certified EMDR therapists using the standard eight-phase protocol. Treatment targets distressing trauma memories through brief, repeated exposure combined with bilateral stimulation (e.g., eye movements or tactile taps) to facilitate adaptive information processing. Sessions include history taking, identification of target memories, assessment of negative and positive cognitions, desensitization, installation, and body scan procedures. Therapists monitor symptom changes throughout and coordinate with OPUS clinicians as needed. EMDR is provided alongside usual OPUS care, with adherence ensured through protocol-based supervision and fidelity checks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- over 18 years of age Diagnosis within schizophrenia spectrum (ICD10 F2X) PTSD symptoms equivalent to above 31 on the PCL-5 Included in Early intervention services (OPUS) Talks and understands Danish
Key exclusion criteria (1 listed)
- Substance or alcohol abuse interfering with the therapy Indication of sever cognitive impairment Changes in antipsychotic treatment within the last month
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 ExposureDistinguishing Features - Prolonged Exposure (PE) Arm This intervention is distinguished by its exclusive reliance on systematic, therapist-guided exposure procedures grounded in emotional-processing theory. PE uses structured imaginal and in-vivo exposure to reduce avoidance and fear responses and does not employ bilateral stimulation, cognitive restructuring, or memory-processing elements characteristic of other trauma-focused approaches. The protocol follows a fixed sequence emphasizing habituation and extinction learning, making it operationally and mechanistically distinct from EMDR and from supportive or stabilization-oriented therapies used in similar clinical studies. | Behavioural | Prolonged Exposure |
| EMDRDistinguishing Features - EMDR Arm This intervention is distinguished by its use of the standardized eight-phase EMDR protocol, which combines brief exposure to trauma memories with bilateral sensory stimulation to facilitate adaptive information processing. EMDR does not require prolonged or repeated imaginal exposure, fear-hierarchy construction, or systematic in-vivo exposure, differentiating it from PE and other exposure-based trauma treatments. Its mechanism centers on accelerating memory reprocessing rather than habituation, and the protocol includes unique components such as cognition rating, desensitization with bilateral stimulation, installation, and body scan procedures. | Behavioural | EMDR |
Primary outcome
Recrutment
Time frame: 6 months
80% of planed participants will be included within 6 months
Retensionrate
Time frame: 8 months
A minimum of 70% of participants will conclude the therapy sessions
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 10 Dec 2025.
- Individual participant dataSharing planned: Yes. If accepted the data will be deposited in the Danish National Archives
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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.
Nikolai Albert principal investigator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure and EMDR in people with SCHIZOPHRENIA 1 (Disorder) and Schizotypal Disorder, run by Nikolai Albert at 1 site in Denmark.
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 1 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: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Nikolai Albert, MD, PhD (+45 29925014, nikolai.albert@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recrutment (time frame: 6 months). The study lists 2 primary outcomes in all. 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 10 Dec 2025.