PTSD - Post Traumatic Stress DisorderFLIP-ITNCT06700590
First-Line Intervention for PTSD - Intensive Treatment
A study testing Intensive Treatment and Treatment as usual in people with PTSD - Post Traumatic Stress Disorder, run by ARQ National Psychotrauma Centre at 4 sites in Netherlands.
Trial summary
The goal of this clinical trial is to learn if an intensive program can treat post-traumatic stress disorder (PTSD) in adults getting treatment for the first time, and whether it has lower societal costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Intensive Treatment and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 4 sitesNetherlands
- Study dates
- 21 Nov 2024to 1 Jul 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- PTSD diagnosis according to DSM-5 (CAPS-5);
- PTSD diagnosis stemming from 2 or more potentially traumatic events (PTEs)
- seeking first-time treatment for PTSD (or less than 8 sessions);
- employed (working or on sick leave for less than two years)
Who cannot join
- Current psychotic disorder, severe alcohol or substance use disorder, high suicidal intent (MINI-S for DSM-5) and a concrete suicide plan, or severe aggressive behavior that poses danger for others
- insufficient command of the Dutch language to be able to complete the assessments. This will be determined through clinical judgment at intake.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands4 sites, 4 recruiting
- Recruiting
ARQ IVP
Diemen, North Holland, 1112 XE
- Recruiting
Psy-Zo!
Groningen, Provincie Groningen, 9747 AN
- Recruiting
Psychotraumacentrum Haarlem
Haarlem, North Holland, 2011 VE
- Recruiting
ARQ Centrum'45
Oegstgeest, South Holland, 2342 AX
About this study
Official title: (Cost)-Effectiveness of Intensive Trauma-Focused Treatment Versus Spaced Trauma-Focused Treatment As First Line Treatment for Post-Traumatic Stress Disorder in Adults with Multiple Trauma Exposure: Randomized Controlled Trial
The goal of this clinical trial is to learn if an intensive program can treat post-traumatic stress disorder (PTSD) in adults getting treatment for the first time, and whether it has lower societal costs. The main questions it aims to answer are:
- Does an intensive program reduce PTSD symptoms?
- How expensive is it on a societal level? Researchers will compare the intensive program to the standard weekly treatment to see if the intensive program works to treat PTSD.
Participants will:
- Get 5 days of intensive treatment in two weeks (with two preparatory and closing sessions), or weekly sessions
- Get questionnaires and interviews 5 times in 9 months
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Intensive Treatment, Treatment as usual
- Keywords
- intensive treatment, massed treatment, randomized controlled trial, RCT, first time treatment
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive TreatmentBehavioural
Participants engage in two preparatory sessions once weekly, lasting 50 minutes each, which focus on psychoeducation and case conceptualization. The core treatment consists of five days of twice-daily sessions delivered over one or two weeks. The first session of the day consists of prolonged exposure (PE). The second session consists of eye movement desensitization and reprocessing (EMDR). Both treatments are performed in strict adherence to their respective manualized protocol. Two closing sessions focus on lessons learned, integration and a prevention plan. The treatment in total lasts 6 weeks and contains 800 minutes of treatment.
To enhance practicality, treatment rotation is allowed and encouraged. Rigorous checks on treatment adhenrence will be implemented.
Treatment as usualBehavioural
Spaced/weekly treatment consists of a treatment-as-usual condition, increasing the representativeness of the control condition. Treatment duration is 800 minutes, either 13 weeks of 60 minutes (with the last sessions being 80 minutes), or 16 weeks of 50 minutes. All evidence-based treatment modalities of the Dutch guidelines are allowed: PE, EMDR, brief eclectic psychotherapy for PTSD (BEPP), narrative exposure therapy (NET), and imaginary rescripting (ImRs). All have common elements of psychoeducation, imaginal exposure, emotional processing, cognitive restructuring and/or meaning making. Treatment adherence will be monitored throughout the intervention. Therapist rotation is not performed
| Study group | Role | What they receive |
|---|---|---|
| massed/intensive treatment | Experimental | Not described Receives: Behavioral: Intensive Treatment |
| spaced/weekly treatment | Active comparator | Not described Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
The primary outcome, severity of Post-Traumatic Stress Disorder (PTSD) is assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). CAPS-5 is a comprehensive 20-item clinical interview that assesses both the DSM-5 PTSD diagnostic criteria and the severity of PTSD symptoms. Scores range from 0 to 80, with higher scores denoting greater symptom severity. The CAPS-5 showed high internal consistency and interrater reliability, good test-retest reliability, and good validity. All the assessors are or will be trained to administer the Dutch versions of the CAPS-5. It requires a total of 225 minutes to complete at all measurement points.
Measured: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Cost-effectiveness (Quality of life)
Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs.
Quality of life will be assessed using the Euro Quality of Life 5 Dimensions (EQ-5D-5L) scale. This scale comprises 14 items categorized into various aspects of health status, rated on a three-point scale.
Measured: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Cost-effectiveness (Mental Health Quality of Life Questionnaire)
Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs.
The Mental Health Quality of Life Questionnaire (MHQoL) will be utilized to assess the quality of life among individuals with mental health issues. The MHQoL comprises a descriptive system (the MHQoL-7D) and a visual analog scale (MHQoL-VAS).
Measured: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Cost-effectiveness (Treatment inventory of costs)
Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. The Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P) will be utilized to map the costs arising from psychosocial problems in adults. It consists of three components: general questions, questions regarding medical care utilization, and questions related to work.
Measured: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Secondary outcomes (10)
International Trauma Questionnaire (ITQ)
The International Trauma Questionnaire (ITQ; Dutch translation) will be used to address the core features of the diagnosis of Post Traumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD) according to the ICD-11 as main study parameter. Several studies have indicated that the preliminary version of the ITQ is a reliable and valid measure of PTSD symptoms. The ITQ assessments will be conducted at all time points, with a total assessment duration of 50 minutes.
Measured: At baseline (T0).
Moral Injury Outcome Scale (MIOS)
Moral Injury will be assessed by the Moral Injury Outcome Scale (MIOS). This scale comprises 14 items categorized into two subscales: Shame-Related and Trust-Violation Related Outcomes. It is used to determine if respondents experienced a Potentially Morally Injurious Event (PMIE) and assess the impact of these experiences on well-being. The MIOS also addresses PTSD symptoms related to PMIE. The 14-item MIOS demonstrates invariance and reliability across countries and exhibits two factors: Shame-Related and Trust-Violation-Related Outcomes.
Measured: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is employed to measure core symptoms of anxiety and depression, excluding physical symptoms. It consists of separate anxiety and depression scales, each with 7 items. The HADS exhibits good homogeneity and test-retest reliability for the total scale and subscales, and its dimensional structure and reliability are stable across different medical settings and age groups.
Measured: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Acceptance and Action Questionnaire (AAQ-II)
Experiential Avoidance will be assessed by the Experiential Avoidance Assessment (AAQ-II): In its Dutch-language version, the Acceptance and Action Questionnaire-II will be used to assess experiential avoidance. It consists of 7 statements, with higher scores indicating lower experiential avoidance and greater acceptance of unpleasant inner experiences. The Dutch AAQ-II has demonstrated similar construct validity and reliability to the English version.
Measured: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Personality Inventory for DSM-5-Brief Form-Adult (PID-5-BF-NL)
Maladaptive Personality Traits will be assessed by the Personality Inventory for DSM-5-Brief Form-Adult (PID-5-BF-NL). The PID-5-BF-NL will be employed to assess maladaptive personality traits as defined in the alternative DSM-5 model for personality disorders. This self-rated scale comprises 25 items evaluating five personality trait domains. The reliability and validity of the PID-5-BF-NL have demonstrated adequacy to good.
Measured: At baseline (T0), and at 6 months (T3)
Dissociative Symptoms Assessment (DSS-4)
Dissociative Symptoms will be assessed using the Dissociative Symptoms Assessment (DSS-4): The DSS, will be utilized to assess psychoform and somatoform dissociative symptoms experienced in the past week. The scale comprises 21 items and exhibits high internal consistency (Cronbach's alpha = .92) and reliability.
Measured: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Crisis Support Scale (CSS)
Social Support will be administered by the Crisis Support Scale (CSS) to evaluate social support, assessing total social support and satisfaction with support. The CSS consists of 7 items and has demonstrated both good validity and reliability. The CSS assessments will be conducted at baseline (T0) and 6 months (T3), with a total assessment duration of 10 minutes.
Measured: At baseline (T0), after 6 months (T3)
Verbal Learning and Memory Test (VLGT)
The Verbal Learning and Memory Test (VLGT), a Dutch version of the American California Verbal Learning Test by Delis, will be employed to assess verbal memory functions in adults. This test evaluates learning performance, speed of learning and forgetting, encoding modes, memorization, recognition over time, sensitivity to interference, the tendency to confabulate, and persistence. The VLGT is a reliable and valid test.
Measured: At baseline (T0), after weekly treatment (T2, 17 weeks)
Harms
Harms will be assessed by inquiring, 'Have you experienced any issues since your last visit?' following the recommendation by the STRONG STAR consortium.
Measured: After intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Treatment satisfaction
Treatment satisfaction will be assessed at 7 weeks (T1) and 17 weeks (T2) for the intensive treatment and treatment as usual, respectively. The Client Satisfaction Questionnaire 8 (CSQ-8) and the Visual Analog Scale will be used. The CSQ-8 is a questionnaire with 8 questions rated on a four-point Likert scale, validated in Dutch samples with high internal consistency and similar psychometric properties to the English version. The Visual Analog Scale with 1 indicating the lowest possible rating and 10 representing the highest possible rating, is utilized for assessing the treatment. Additionally, it includes an inquiry about what modifications or improvements are required to achieve a perfect rating of 10.
Measured: at 7 weeks (T1) and 17 weeks (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start21 Nov 2024
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARQ National Psychotrauma Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Rijksuniversiteit Groningen, Psychotraumacentrum Haarlem, ARQ IVP BV, Militaire GGZ, Psy-zo BV, Erasmus University Rotterdam
- Responsible party
- Sponsor
- Investigators
- Mirjam Mink-Nijdam, PhD, Principal investigator, ARQ National Psychotrauma Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700590
- Sponsor's protocol ID
- NL86057.018.24
- Other IDs
- 10390092110006
- Acronym
- FLIP-IT
- Status last verified
- Jan 2025
- First submitted
- 18 Nov 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Metadata will be placed in a data repository. IPD can be requested with the research team.
Publications
Kemmere B, van Pelt YT, Lommen MJJ, Huntjens RJC, Olff M, Mendez MZ, Matthijssen S, Hakkaart-van Roijen L, Nijdam MJ, Heide FJJT. Cost-effectiveness of massed versus spaced trauma-focused treatment as first-line treatment for post-traumatic stress disorder in adults with multiple trauma exposure: protocol for a single-blind non-inferiority randomised controlled trial. BMJ Open. 2025 May 23;15(5):e102530. doi: 10.1136/bmjopen-2025-102530.
PubMed 40409963
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Cost)-Effectiveness of Intensive Trauma-Focused Treatment Versus Spaced Trauma-Focused Treatment As First Line Treatment for Post-Traumatic Stress Disorder in Adults with Multiple Trauma Exposure: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06700590
- Acronym / sponsor ID
- FLIP-IT / NL86057.018.24
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- intensive treatment, massed treatment, randomized controlled trial, RCT, first time treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- ARQ National Psychotrauma CentreUniversity, hospital or other
- Collaborators
- Rijksuniversiteit Groningen, Psychotraumacentrum Haarlem, ARQ IVP BV, Militaire GGZ, Psy-zo BV, Erasmus University Rotterdam
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 22 Nov 2024 (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.
The goal of this clinical trial is to learn if an intensive program can treat post-traumatic stress disorder (PTSD) in adults getting treatment for the first time, and whether it has lower societal costs. The main questions it aims to answer are:
- Does an intensive program reduce PTSD symptoms?
- How expensive is it on a societal level? Researchers will compare the intensive program to the standard weekly treatment to see if the intensive program works to treat PTSD.
Participants will:
- Get 5 days of intensive treatment in two weeks (with two preparatory and closing sessions), or weekly sessions
- Get questionnaires and interviews 5 times in 9 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| massed/intensive treatment | Experimental | Behavioral: Intensive Treatment |
| spaced/weekly treatment | Active comparator | Behavioral: Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- PTSD diagnosis according to DSM-5 (CAPS-5);
- PTSD diagnosis stemming from 2 or more potentially traumatic events (PTEs)
- seeking first-time treatment for PTSD (or less than 8 sessions);
- employed (working or on sick leave for less than two years)
Key exclusion criteria (2 listed)
- Current psychotic disorder, severe alcohol or substance use disorder, high suicidal intent (MINI-S for DSM-5) and a concrete suicide plan, or severe aggressive behavior that poses danger for others
- insufficient command of the Dutch language to be able to complete the assessments. This will be determined through clinical judgment at intake.
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 |
|---|---|---|
| Intensive TreatmentParticipants engage in two preparatory sessions once weekly, lasting 50 minutes each, which focus on psychoeducation and case conceptualization. The core treatment consists of five days of twice-daily sessions delivered over one or two weeks. The first session of the day consists of prolonged exposure (PE). The second session consists of eye movement desensitization and reprocessing (EMDR). Both treatments are performed in strict adherence to their respective manualized protocol. Two closing sessions focus on lessons learned, integration and a prevention plan. The treatment in total lasts 6 weeks and contains 800 minutes of treatment. To enhance practicality, treatment rotation is allowed and encouraged. Rigorous checks on treatment adhenrence will be implemented. | Behavioural | massed/intensive treatment |
| Treatment as usualSpaced/weekly treatment consists of a treatment-as-usual condition, increasing the representativeness of the control condition. Treatment duration is 800 minutes, either 13 weeks of 60 minutes (with the last sessions being 80 minutes), or 16 weeks of 50 minutes. All evidence-based treatment modalities of the Dutch guidelines are allowed: PE, EMDR, brief eclectic psychotherapy for PTSD (BEPP), narrative exposure therapy (NET), and imaginary rescripting (ImRs). All have common elements of psychoeducation, imaginal exposure, emotional processing, cognitive restructuring and/or meaning making. Treatment adherence will be monitored throughout the intervention. Therapist rotation is not performed | Behavioural | spaced/weekly treatment |
Primary outcome
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
The primary outcome, severity of Post-Traumatic Stress Disorder (PTSD) is assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). CAPS-5 is a comprehensive 20-item clinical interview that assesses both the DSM-5 PTSD diagnostic criteria and the severity of PTSD symptoms. Scores range from 0 to 80, with higher scores denoting greater symptom severity. The CAPS-5 showed high internal consistency and interrater reliability, good test-retest reliability, and good validity. All the assessors are or will be trained to administer the Dutch versions of the CAPS-5. It requires a total of 225 minutes to complete at all measurement points.
Cost-effectiveness (Quality of life)
Time frame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. Quality of life will be assessed using the Euro Quality of Life 5 Dimensions (EQ-5D-5L) scale. This scale comprises 14 items categorized into various aspects of health status, rated on a three-point scale.
Cost-effectiveness (Mental Health Quality of Life Questionnaire)
Time frame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. The Mental Health Quality of Life Questionnaire (MHQoL) will be utilized to assess the quality of life among individuals with mental health issues. The MHQoL comprises a descriptive system (the MHQoL-7D) and a visual analog scale (MHQoL-VAS).
Cost-effectiveness (Treatment inventory of costs)
Time frame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. The Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P) will be utilized to map the costs arising from psychosocial problems in adults. It consists of three components: general questions, questions regarding medical care utilization, and questions related to work.
10 secondary outcomes
International Trauma Questionnaire (ITQ)
Time frame: At baseline (T0).
Moral Injury Outcome Scale (MIOS)
Time frame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Acceptance and Action Questionnaire (AAQ-II)
Time frame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Personality Inventory for DSM-5-Brief Form-Adult (PID-5-BF-NL)
Time frame: At baseline (T0), and at 6 months (T3)
Dissociative Symptoms Assessment (DSS-4)
Time frame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Crisis Support Scale (CSS)
Time frame: At baseline (T0), after 6 months (T3)
Verbal Learning and Memory Test (VLGT)
Time frame: At baseline (T0), after weekly treatment (T2, 17 weeks)
Harms
Time frame: After intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Treatment satisfaction
Time frame: at 7 weeks (T1) and 17 weeks (T2)
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 3 Mar 2025.
- Derived from this study: PubMed 40409963Kemmere B, van Pelt YT, Lommen MJJ, Huntjens RJC, Olff M, Mendez MZ, Matthijssen S, Hakkaart-van Roijen L, Nijdam MJ, Heide FJJT. Cost-effectiveness of massed versus spaced trauma-focused treatment as first-line treatment for post-traumatic stress disorder in adults with multiple trauma exposure: protocol for a single-blind non-inferiority randomised controlled trial. BMJ Open. 2025 May 23;15(5):e102530. doi: 10.1136/bmjopen-2025-102530.
- Individual participant dataSharing planned: Yes. Metadata will be placed in a data repository. IPD can be requested with the research team.
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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.
Mirjam Mink-Nijdam, PhD principal investigator
ARQ National Psychotrauma Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Treatment and Treatment as usual in people with PTSD - Post Traumatic Stress Disorder, run by ARQ National Psychotrauma Centre at 4 sites in Netherlands.
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 5 inclusion and 2 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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 Mirjam Mink-Nijdam, PhD (+31(0)20 840 7640, m.mink@centrum45.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06700590, which also lists 1 linked publication.
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 3 Mar 2025.