Post-traumatic Stress DisorderNCT06143982
Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (s)PTSD: a Multi-center RCT
A study testing Brief Intensive Trauma Treatment in people with Post-traumatic Stress Disorder, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in 2 countries.
Trial summary
The primary objective of this study is to examine the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents with (s)PTSD. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Brief Intensive Trauma Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 5 Oct 2022to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 12-18 years of age;
- with a history of psychological trauma (conform the Life Events Checklist of the Clinician Administered PTSD Scale for Children and Adolescents DSM-5 (CAPS-CA DSM-5) (Nader, 2004; van Meijel et al., 2019);
- at least subthreshold PTSD criteria, conform the CAPS-CA DSM-5, i.e.;
- fully meeting criterion A, F and G and at least one symptom of criteria B, C, D and E;
- or fully meeting criterion A, F, G and at least the B, C, D or E symptom clusters;
- and written informed consent must be provided by the adolescent and, for adolescents aged 12-15 years, all legal guardians.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study in case of:
- inability to speak and write Dutch;
- estimated or determined mental retardation (IQ <70);
- suffering from ongoing trauma by a parent who is part of the adolescent's current primary-care system.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites, 2 recruiting
- Recruiting
Karakter
Almelo, Overijsel, 7600 AP
Rik Knipschild,, MSc, 31629607864, r.knipschild@karakter.com
- Recruiting
Amsterdam UMC, location AMC/Levvel
Amsterdam, North Holland, 1105 AZ
Myrna Westerveld, MSc, +31643300014, m.m.westerveld@amsterdamumc.nl
Bonaire, Saint Eustatius and Saba 1 site, 1 recruiting
- Recruiting
Mental Health Caribbean
Kralendijk
Marielle Hoekstra, MSc, +599-7170125, marielle.hoekstra@mentalhealthcaribbean.com
About this study
Official title: Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (Subclinical) PTSD: a Multi-center Randomized Controlled Trial
The primary objective of this study is to examine the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents with (s)PTSD.
Read the detailed description
This study is a multi-center, single-blinded RCT. Adolescents (12-18 years old) with (s)PTSD will be randomly allocated by an independent researcher to the BITT (n=50) versus a waitlist control group (WLCG; n=50), stratified by center. Measurements are done at comparable time intervals for both groups: at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up. The WLCG receives BITT after the 3 months follow-up.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Brief Intensive Trauma Treatment
- Keywords
- PTSD, Trauma, Intensive treatment, BITT, Adolescents
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Intensive Trauma TreatmentBehavioural
BITT is an outpatient, intensive, one-week individual trauma therapy program. BITT is based on well-established protocols, consisting of two 90-minutes trauma therapy sessions a day (trauma exposure in the morning and EMDR in the afternoon), two psychomotor therapy sessions a day (1x60 minutes, 1x45 minutes), one 90-minutes psycho-education and social support skill training for parents a day, and a 90-minutes family therapy session at the end of the week (sharing the trauma narrative).
| Study group | Role | What they receive |
|---|---|---|
| Brief Intensive Trauma Treatment | Experimental | If allocated to the intervention group, participants follow the Brief Intensive Trauma Treatment (BITT). Receives: Behavioral: Brief Intensive Trauma Treatment |
| Waitlist control group | No intervention | When allocated to the WLCG, participants receive BITT after a 3 months waiting period. The WLCG receives no care during the treatment phase (one week) of the intervention group. Besides this week the WLCG can undergo every treatment including EMDR and TF-CBT during the 3 months waiting period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Posttraumatic stress symptoms (CAPS-CA)
The primary objective of this study is to test the effectiveness of BITT versus a WLCG on adolescents (12-18 years) with (s)PTSD. PTSD symptoms will be assessed by the Clinician Administered PTSD Scale for Children and Adolescents DSM-5 (CAPS-CA DSM 5; Van Meijel et al., 2013). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on (s)PTSD symptoms will be tested.
Measured: PTSD symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Posttraumatic stress symptoms (KJTS)
The primary objective of this study is to test the effectiveness of BITT versus a WLCG on adolescents (12-18 years) with (s)PTSD. PTSD symptoms will be assessed by the Child and Adolescent Trauma Screening (In Dutch: Kind en Jeugd Trauma Screener (KJTS; Kooij \& Lindauer, 2019). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on (s)PTSD symptoms will be tested.
Measured: PTSD symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Secondary outcomes (10)
Changes in Anger symptoms (PROMIS)
The second objective is to test the effectiveness of BITT versus a WLCG on anger symptoms. Anger symptoms will be measures with the Patient-Reported Outcomes Measurement Information System (PROMIS; Terwee et al., 2014). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on anger will be tested.
Measured: Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Anger symptoms (SCID-5 Junior)
Anger symptoms will also be measures with the Structured Clinical Interview for DSM-5 Childhood Disorders (SCID-5 Junior; module 12 Disruptive, impulse control and other behavioral disorders; Wante et al., 2020). The SCID-5 module will be administered when the adolescent scores T ≥ 60 on the PROMIS questionnaire.
Measured: Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Anxiety symptoms (PROMIS)
The third objective is to test the effectiveness of BITT versus a WLCG on anxiety symptoms. Anxiety symptoms will be measures with the Patient-Reported Outcomes Measurement Information System (PROMIS; Terwee et al., 2014). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on anxiety will be tested.
Measured: Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Anxiety symptoms (SCID-5-Junior)
Anxiety symptoms will also be measures with the Structured Clinical Interview for DSM-5 Childhood Disorders (SCID-5 Junior; Module 6 Anxiety disorder; Wante et al., 2020). The SCID-5 module will be administered when the adolescent scores T ≥ 60 on the PROMIS questionnaire.
Measured: Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Depression symptoms (PROMIS)
The fourth objective is to test the effectiveness of BITT versus a WLCG on depression symptoms. Depression symptoms will be measures with the Patient-Reported Outcomes Measurement Information System (PROMIS; Terwee et al., 2014). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) depression symptoms will be tested.
Measured: Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Depression symptoms (SCID-5-Junior)
Depression symptoms will also be measures with the Structured Clinical Interview for DSM-5 Childhood Disorders (SCID-5 Junior; Module 3 Depressive mood disorders; Wante et al., 2020). The SCID-5 module will be administered when the adolescent scores T ≥ 60 on the PROMIS questionnaire.
Measured: Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Quality of life
The fifth objective of this study is to examine the effectiveness of BITT versus a WLCG on quality of life. Quality of life will be measures with the EuroQol-5D (EuroQol-Group, 2009). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on quality of life will be tested.
Measured: Quality of life is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Risk-behavior and safety
The sixth objective is to test if BITT is a safe intervention. This will be measured with a risk-behavior and safety questionnaire based on previous work by Hendriks et al. (2017) regarding: self-harm, suicidality and aggressive behavior.
Measured: Risk-behavior and safety is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Dropout rates
The seventh objective is to examine if BITT leads to less drop out rates. Drop outs will be documented in an Excel file (yes/no).
Measured: Dropout is measures at each day of the BITT week (in total 5 days).
Cost-effectiveness
The eighth objective is to examine the cost-effectiveness of BITT. Cost-effectiveness will be measured with the Treatment Inventory of Costs in Psychiatric clients (TiC-PY/proxy) (Bouwmans et al., 2012).
Measured: Cost-effectiveness is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start5 Oct 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2026 (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 Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- A two-arm, mutli-center, randomized controlled trial (RCT). Adolescents (12-18 years old) with (s)PTSD will be randomly allocated by an independent researcher to the intervention group (n=50) versus a waitlist control group (WLCG; n=50), stratified by center. If allocated to the intervention group, participants follow the Brief Intensive Trauma Treatment (BITT). When allocated to the WLCG, participants receive BITT after a 3 months waiting period. Measurements are done at comparable time intervals for both groups: at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. R.J.L. (Ramón) Lindauer, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Ramón Lindauer, Prof. dr., Principal investigator, Amsterdam UMC, location AMC/Levvel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143982
- Sponsor's protocol ID
- Effectstudie BITT
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Westerveld MM, van der Mheen M, Knipschild R, Maijer K, de Keizer-Altink ME, Albisser N, Hoekstra MJE, Timmermans-Jansen A, Zijp R, Krabbendam AA, van Steensel FJAB, Kan KJ, Huyser C, Staal WG, Utens EMWJ, Lindauer RJL. Short- and Long-Term Effectiveness of Brief Intensive Trauma Treatment for Adolescents With Posttraumatic Stress Disorder and Their Caregivers: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 30;14:e66115. doi: 10.2196/66115.
PubMed 40306642
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (Subclinical) PTSD: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06143982
- Acronym / sponsor ID
- Effectstudie BITT
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- PTSD, Trauma, Intensive treatment, BITT, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 22 Nov 2023 (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 primary objective of this study is to examine the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents with (s)PTSD.
Detailed description
This study is a multi-center, single-blinded RCT. Adolescents (12-18 years old) with (s)PTSD will be randomly allocated by an independent researcher to the BITT (n=50) versus a waitlist control group (WLCG; n=50), stratified by center. Measurements are done at comparable time intervals for both groups: at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up. The WLCG receives BITT after the 3 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A two-arm, mutli-center, randomized controlled trial (RCT). Adolescents (12-18 years old) with (s)PTSD will be randomly allocated by an independent researcher to the intervention group (n=50) versus a waitlist control group (WLCG; n=50), stratified by center. If allocated to the intervention group, participants follow the Brief Intensive Trauma Treatment (BITT). When allocated to the WLCG, participants receive BITT after a 3 months waiting period. Measurements are done at comparable time intervals for both groups: at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
| Arm | Type | Receives |
|---|---|---|
| Brief Intensive Trauma Treatment | Experimental | Behavioral: Brief Intensive Trauma TreatmentIf allocated to the intervention group, participants follow the Brief Intensive Trauma Treatment (BITT). |
| Waitlist control group | No intervention | –When allocated to the WLCG, participants receive BITT after a 3 months waiting period. The WLCG receives no care during the treatment phase (one week) of the intervention group. Besides this week the WLCG can undergo every treatment including EMDR and TF-CBT during the 3 months waiting period. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 12-18 years of age;
- with a history of psychological trauma (conform the Life Events Checklist of the Clinician Administered PTSD Scale for Children and Adolescents DSM-5 (CAPS-CA DSM-5) (Nader, 2004; van Meijel et al., 2019);
- at least subthreshold PTSD criteria, conform the CAPS-CA DSM-5, i.e.;
- and written informed consent must be provided by the adolescent and, for adolescents aged 12-15 years, all legal guardians.
Key exclusion criteria (4 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study in case of:
- inability to speak and write Dutch;
- estimated or determined mental retardation (IQ <70);
- suffering from ongoing trauma by a parent who is part of the adolescent's current primary-care system.
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 |
|---|---|---|
| Brief Intensive Trauma TreatmentBITT is an outpatient, intensive, one-week individual trauma therapy program. BITT is based on well-established protocols, consisting of two 90-minutes trauma therapy sessions a day (trauma exposure in the morning and EMDR in the afternoon), two psychomotor therapy sessions a day (1x60 minutes, 1x45 minutes), one 90-minutes psycho-education and social support skill training for parents a day, and a 90-minutes family therapy session at the end of the week (sharing the trauma narrative). | Behavioural | Brief Intensive Trauma Treatment |
Primary outcome
Changes in Posttraumatic stress symptoms (CAPS-CA)
Time frame: PTSD symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
The primary objective of this study is to test the effectiveness of BITT versus a WLCG on adolescents (12-18 years) with (s)PTSD. PTSD symptoms will be assessed by the Clinician Administered PTSD Scale for Children and Adolescents DSM-5 (CAPS-CA DSM 5; Van Meijel et al., 2013). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on (s)PTSD symptoms will be tested.
Changes in Posttraumatic stress symptoms (KJTS)
Time frame: PTSD symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
The primary objective of this study is to test the effectiveness of BITT versus a WLCG on adolescents (12-18 years) with (s)PTSD. PTSD symptoms will be assessed by the Child and Adolescent Trauma Screening (In Dutch: Kind en Jeugd Trauma Screener (KJTS; Kooij \& Lindauer, 2019). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on (s)PTSD symptoms will be tested.
10 secondary outcomes
Changes in Anger symptoms (PROMIS)
Time frame: Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Anger symptoms (SCID-5 Junior)
Time frame: Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Anxiety symptoms (PROMIS)
Time frame: Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Anxiety symptoms (SCID-5-Junior)
Time frame: Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Depression symptoms (PROMIS)
Time frame: Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Depression symptoms (SCID-5-Junior)
Time frame: Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Quality of life
Time frame: Quality of life is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Risk-behavior and safety
Time frame: Risk-behavior and safety is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Dropout rates
Time frame: Dropout is measures at each day of the BITT week (in total 5 days).
Cost-effectiveness
Time frame: Cost-effectiveness is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 40306642Westerveld MM, van der Mheen M, Knipschild R, Maijer K, de Keizer-Altink ME, Albisser N, Hoekstra MJE, Timmermans-Jansen A, Zijp R, Krabbendam AA, van Steensel FJAB, Kan KJ, Huyser C, Staal WG, Utens EMWJ, Lindauer RJL. Short- and Long-Term Effectiveness of Brief Intensive Trauma Treatment for Adolescents With Posttraumatic Stress Disorder and Their Caregivers: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 30;14:e66115. doi: 10.2196/66115.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ramón Lindauer, Prof. dr. principal investigator
Amsterdam UMC, location AMC/Levvel
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intensive Trauma Treatment in people with Post-traumatic Stress Disorder, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in 2 countries.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Bonaire, Saint Eustatius and Saba . 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myrna Westerveld, MSc (+31643300014, m.m.westerveld@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Posttraumatic stress symptoms (CAPS-CA) (time frame: PTSD symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.). 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?
On the ClinicalTrials.gov record for NCT06143982, 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 22 Nov 2023.