Posttraumatic Stress DisorderCBITSNCT06038357
CBITS - Treat Trauma in Child Welfare
A study testing CBITS and TAU+ in people with Posttraumatic Stress Disorder, run by University Hospital Ulm.
Trial summary
The goal of this randomized controlled trial is to evaluate the effectiveness of the trauma-focused group intervention CBITS compared with enhanced treatment as usual (TAU+) in child welfare programs in Germany. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- CBITS and TAU+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 30 Oct 2025
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-16 years, because this age range reflects the age range in the CBITS evaluation studies, and this age range is specified in the CBITS manual and toolkit).
- Having experienced at least one traumatic event (based on DSM-5 or ICD-10/ICD-11 criteria) as CBITS is designed for children and adolescents with a trauma history.
- At least moderate PTSS (at least 21 points on the CATS-2) as this is recommended in the intervention manual. Participants don't have to fulfill PTSD criteria as the manual does not name this a pre-condition for participation. Additionally, there is large evidence that also youth with subthreshold PTSS show high functional impairment, but respond very well to trauma-focused interventions.
- Being currently cared for by a child welfare program (safe and stable living conditions), planned further stay in the program for at least 12 months in order to complete the CBITS intervention and 10-month follow-up.
- Willingness and informed assent/consent of the participant as well as informed consent of the caregiver/legal guardian to participate in the study (sufficient motivation for group intervention and compliance with the study design).
Who cannot join
- Current psychosis for safety reasons and in because in this case another intervention another intervention has priority (same explanation for 2-4).
- severe harm to self or others
- severe substance disorder
- acute suicidality
- Severe mental retardation as there is a certain necessity of sufficient cognitive abilities to benefit from CBITS, to recall trauma memories and to create a trauma narrative.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of "Cognitive Behavioral Intervention for Trauma in Schools" (CBITS) in Child Welfare Programs in Germany: A Randomized Controlled Trial
The goal of this randomized controlled trial is to evaluate the effectiveness of the trauma-focused group intervention CBITS compared with enhanced treatment as usual (TAU+) in child welfare programs in Germany. The target group are traumatized children and adolescents in out-of-home care who report posttraumatic stress symptoms (PTSS).
Read the detailed description
The study objectives are
- Evaluate the effectiveness of CBITS compared to TAU+ regarding PTSS symptom reduction (primary outcome), anxiety, depression, quality of life and functional level, and continuance of the child welfare program (secondary outcomes) at 4-month follow-up
- Investigate potential long-term effects of the treatment in the CBITS condition regarding the primary and secondary outcomes at 10-month follow-up.
- Implement CBITS as an outreach intervention into routine mental health care for traumatized children, to evaluate treatment fidelity, treatment completion and investigate different potential individual or structural factors that might have an impact on the implementation.
- To assess the readiness in child welfare programs to collaborate with mental health services and the role of institutional environments for developmental trajectories.
Participants and their caregivers will complete questionnaires at three measurement time points. Weekly PTSS symptom monitoring during treatment and alliance ratings (participants and therapists) at the beginning and the end of the intervention will be implemented. Trained therapists at three study centers (Marburg, Ulm, Bochum) will complete questionnaires before their training and after CBITS implementation. Site monitoring and auditing, as well as reliability checks of the data will be conducted by an independent data manager. Randomization will be implemented by an independent Institute at Ulm University. Standard Operating Procedures (SOPs) to address patient recruitment, data collection, data management, reporting for adverse events, and change management will be provided. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect were performed via the program G-Power, in collaboration with an independent statistical advisor, before proposal submission. A plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results are prepared in collaboration with the independent statistical advisor. We will following Intention-to-treat (ITT) principles in our analyses. The statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, are specified in the study protocol which will be published before data collection.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- CBITS, TAU+
- Keywords
- children, adolescents, PTSD, trauma-focused group intervention, randomized controlled trial, child welfare programs, CBITS
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBITSBehavioural
Also called Cognitive Behavioral Intervention for Trauma in Schools
The CBITS program is a skills-based group and individual intervention, which uses evidence-based cognitive-behavioral techniques (e.g. psychoeducation, relaxation, social problem solving, cognitive restructuring, and exposure) and is designed for delivery by mental health professionals. The program consists of 10 45-minute group sessions (about 6-8 students/participants per group), 1-3 individual sessions, 2 parent/caregiver psychoeducational sessions, and 1 teacher/ child welfare staff educational session. For this study, we will specifically train and supervise study therapists to deliver the intervention within child welfare programs.
TAU+Other
In the control condition (TAU+), child welfare programs will follow their usual procedures (i.e. routine care of child welfare, referral to medical practitioners and psychotherapists, handling of prescribed medication, referral to inpatient treatments in case of risk to self and others) which reflects treatment as usual in child welfare programs and the mental health care system in Germany. Additionally, participants in the control condition will receive the same baseline assessment and reporting of screening results as participants in the treatment condition after each assessment.
| Study group | Role | What they receive |
|---|---|---|
| CBITS | Experimental | Cognitive Behavioral Intervention for Trauma in Schools (CBITS) Receives: Behavioral: CBITS |
| Treatment as usual (TAU+) | Active comparator | Enhanced Treatment as Usual means regular care in child welfare program and mental health care. They also receive feedback on their assessments and a treatment recommendation. Receives: Other: TAU+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child and Adolescent Trauma Screen - Second Version (CATS-2 self-report)
The CATS-2 is a questionnaire to screen for potentially traumatic events and assesses symptoms of PTSD/Complex-PTSD (CPTSD) (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and International Classification of Diseases Version 11 (ICD-11)) in children and adolescents. The minimal score value is "0", the maximum score value is "60", while higher scores mean a worse outcome.
Measured: baseline, 4-month follow-up, 10-month follow-up (primary endpoint 4-months follow up)
Secondary outcomes (4)
Revised Child Anxiety and Depression Scale (RCADS) (self-and caregiver report)
The RCADS is a 47-item, self- and caregiver-report questionnaire with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). For the anxiety subscale the minimum score value is "0", the maximum score value is "111", while higher scores mean more anxiety. For the depression subscale the minimum score value is "0", the maximum score value is "30", while higher scores mean worse depressive symptoms. Therefore, the minimum score value is "0", the maximum score value is "141", while higher scores mean a worse outcome.
Measured: baseline, 4-month follow-up, 10-month follow-up
Screening and Promotion of Children and Adolescents Health: A European Public Health Perspective (KIDSCREEN questionnaire) (self-and caregiver report)
Quality of life will be assessed via the KIDSCREEN-10 which is a generic health related quality of life measure. The minimum score value is "10", the maximum score value is "50", while higher scores mean a better quality of life.
Measured: baseline, 4-month follow-up, 10-month follow-up
Child and Adolescent Trauma Screen - Second Version (CATS-2 caregiver-report)
corresponding measure to CATS-2 self-report, completed by the participants' caregivers. The minimum score value is "0", the maximum score value is "60", while higher scores mean a worse outcome.
Measured: baseline, 4-month follow-up, 10-month follow-up
Children's Global Assessment Scale (CGAS Caregiver-report)
The level of functioning will be assessed via the CGAS. The minimum score value is "1", the maximum score value is "100", while higher scores mean a higher functioning level.
Measured: baseline, 4-month follow-up, 10-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic 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
- CBITS intervention vs. Treatment as Usual (TAU+)
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Ruhr University of Bochum, Philipps University Marburg
- Responsible party
- Principal investigator, Dr. Elisa Pfeiffer, University Hospital Ulm
- Investigators
- Elisa Pfeiffer, PhD, Principal investigator, Ulm University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038357
- Sponsor's protocol ID
- DFG PF 990/4-1 - AO 692822
- Acronym
- CBITS
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes - Individual participant data (IPD) will be made available to other researchers on request, after publication of the main results and after data sharing agreements are concluded. All IPD that underlie results in a publication will be shared. The study protocol and statistical analysis plan will be shared. IPD and additional supporting information will become available for 2 years once summary data is published. Requests for IPD data and additional supporting information will be reviewed by the leaders of the project (E. Pfeiffer and C. Sachses). There is no web address about the plan to share IPD available.
Publications
Sachser C, Berliner L, Risch E, Rosner R, Birkeland MS, Eilers R, Hafstad GS, Pfeiffer E, Plener PL, Jensen TK. The child and Adolescent Trauma Screen 2 (CATS-2) - validation of an instrument to measure DSM-5 and ICD-11 PTSD and complex PTSD in children and adolescents. Eur J Psychotraumatol. 2022 Aug 1;13(2):2105580. doi: 10.1080/20008066.2022.2105580. eCollection 2022.
PubMed 35928521Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.
PubMed 10937431Shaffer D, Gould MS, Brasic J, Ambrosini P, Fisher P, Bird H, Aluwahlia S. A children's global assessment scale (CGAS). Arch Gen Psychiatry. 1983 Nov;40(11):1228-31. doi: 10.1001/archpsyc.1983.01790100074010.
PubMed 6639293Waldmann T, Stiawa M, Dinc U, Saglam G, Busmann M, Daubmann A, Adema B, Wegscheider K, Wiegand-Grefe S, Kilian R. Costs of health and social services use in children of parents with mental illness. Child Adolesc Psychiatry Ment Health. 2021 Feb 20;15(1):10. doi: 10.1186/s13034-021-00360-y.
PubMed 33610177Ehrhart MG, Aarons GA, Farahnak LR. Going above and beyond for implementation: the development and validity testing of the Implementation Citizenship Behavior Scale (ICBS). Implement Sci. 2015 May 7;10:65. doi: 10.1186/s13012-015-0255-8.
PubMed 25948489Rye M, Torres EM, Friborg O, Skre I, Aarons GA. The Evidence-based Practice Attitude Scale-36 (EBPAS-36): a brief and pragmatic measure of attitudes to evidence-based practice validated in US and Norwegian samples. Implement Sci. 2017 Apr 4;12(1):44. doi: 10.1186/s13012-017-0573-0.
PubMed 28372587Bieda A, Pflug V, Scholten S, Lippert MW, Ladwig I, Nestoriuc Y, Schneider S. [Unwanted Side Effects in Children and Youth Psychotherapy - Introduction and Recommendations]. Psychother Psychosom Med Psychol. 2018 Sep;68(9-10):383-390. doi: 10.1055/s-0044-102291. Epub 2018 May 30. German.
PubMed 29847849Pfeiffer E, Dorrie L, Koksal J, Krech F, Muche R, Segler J, Sachser C. Evaluation of "Cognitive Behavioral Intervention for Trauma in Schools" (CBITS) in child welfare programs in Germany: study protocol of a randomized controlled trial. Trials. 2024 Jun 19;25(1):399. doi: 10.1186/s13063-024-08190-x.
PubMed 38898537
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of "Cognitive Behavioral Intervention for Trauma in Schools" (CBITS) in Child Welfare Programs in Germany: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06038357
- Acronym / sponsor ID
- CBITS / DFG PF 990/4-1 - AO 692822
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- children, adolescents, PTSD, trauma-focused group intervention, randomized controlled trial, child welfare programs, CBITS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital UlmUniversity, hospital or other
- Collaborators
- Ruhr University of Bochum, Philipps University Marburg
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 14 Sep 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 goal of this randomized controlled trial is to evaluate the effectiveness of the trauma-focused group intervention CBITS compared with enhanced treatment as usual (TAU+) in child welfare programs in Germany. The target group are traumatized children and adolescents in out-of-home care who report posttraumatic stress symptoms (PTSS).
Detailed description
The study objectives are
- Evaluate the effectiveness of CBITS compared to TAU+ regarding PTSS symptom reduction (primary outcome), anxiety, depression, quality of life and functional level, and continuance of the child welfare program (secondary outcomes) at 4-month follow-up
- Investigate potential long-term effects of the treatment in the CBITS condition regarding the primary and secondary outcomes at 10-month follow-up.
- Implement CBITS as an outreach intervention into routine mental health care for traumatized children, to evaluate treatment fidelity, treatment completion and investigate different potential individual or structural factors that might have an impact on the implementation.
- To assess the readiness in child welfare programs to collaborate with mental health services and the role of institutional environments for developmental trajectories.
Participants and their caregivers will complete questionnaires at three measurement time points. Weekly PTSS symptom monitoring during treatment and alliance ratings (participants and therapists) at the beginning and the end of the intervention will be implemented. Trained therapists at three study centers (Marburg, Ulm, Bochum) will complete questionnaires before their training and after CBITS implementation. Site monitoring and auditing, as well as reliability checks of the data will be conducted by an independent data manager. Randomization will be implemented by an independent Institute at Ulm University. Standard Operating Procedures (SOPs) to address patient recruitment, data collection, data management, reporting for adverse events, and change management will be provided. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect were performed via the program G-Power, in collaboration with an independent statistical advisor, before proposal submission. A plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results are prepared in collaboration with the independent statistical advisor. We will following Intention-to-treat (ITT) principles in our analyses. The statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, are specified in the study protocol which will be published before data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- CBITS intervention vs. Treatment as Usual (TAU+)
| Arm | Type | Receives |
|---|---|---|
| CBITS | Experimental | Behavioral: CBITSCognitive Behavioral Intervention for Trauma in Schools (CBITS) |
| Treatment as usual (TAU+) | Active comparator | Other: TAU+Enhanced Treatment as Usual means regular care in child welfare program and mental health care. They also receive feedback on their assessments and a treatment recommendation. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 8-16 years, because this age range reflects the age range in the CBITS evaluation studies, and this age range is specified in the CBITS manual and toolkit).
- Having experienced at least one traumatic event (based on DSM-5 or ICD-10/ICD-11 criteria) as CBITS is designed for children and adolescents with a trauma history.
- At least moderate PTSS (at least 21 points on the CATS-2) as this is recommended in the intervention manual. Participants don't have to fulfill PTSD criteria as the manual does not name this a pre-condition for participation. Additionally, there is large evidence that also youth with subthreshold PTSS show high functional impairment, but respond very well to trauma-focused interventions.
- Being currently cared for by a child welfare program (safe and stable living conditions), planned further stay in the program for at least 12 months in order to complete the CBITS intervention and 10-month follow-up.
- Willingness and informed assent/consent of the participant as well as informed consent of the caregiver/legal guardian to participate in the study (sufficient motivation for group intervention and compliance with the study design).
Key exclusion criteria (5 listed)
- Current psychosis for safety reasons and in because in this case another intervention another intervention has priority (same explanation for 2-4).
- severe harm to self or others
- severe substance disorder
- acute suicidality
- Severe mental retardation as there is a certain necessity of sufficient cognitive abilities to benefit from CBITS, to recall trauma memories and to create a trauma narrative.
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 |
|---|---|---|
| CBITSAlso: Cognitive Behavioral Intervention for Trauma in SchoolsThe CBITS program is a skills-based group and individual intervention, which uses evidence-based cognitive-behavioral techniques (e.g. psychoeducation, relaxation, social problem solving, cognitive restructuring, and exposure) and is designed for delivery by mental health professionals. The program consists of 10 45-minute group sessions (about 6-8 students/participants per group), 1-3 individual sessions, 2 parent/caregiver psychoeducational sessions, and 1 teacher/ child welfare staff educational session. For this study, we will specifically train and supervise study therapists to deliver the intervention within child welfare programs. | Behavioural | CBITS |
| TAU+In the control condition (TAU+), child welfare programs will follow their usual procedures (i.e. routine care of child welfare, referral to medical practitioners and psychotherapists, handling of prescribed medication, referral to inpatient treatments in case of risk to self and others) which reflects treatment as usual in child welfare programs and the mental health care system in Germany. Additionally, participants in the control condition will receive the same baseline assessment and reporting of screening results as participants in the treatment condition after each assessment. | Other | Treatment as usual (TAU+) |
Primary outcome
Child and Adolescent Trauma Screen - Second Version (CATS-2 self-report)
Time frame: baseline, 4-month follow-up, 10-month follow-up (primary endpoint 4-months follow up)
The CATS-2 is a questionnaire to screen for potentially traumatic events and assesses symptoms of PTSD/Complex-PTSD (CPTSD) (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and International Classification of Diseases Version 11 (ICD-11)) in children and adolescents. The minimal score value is "0", the maximum score value is "60", while higher scores mean a worse outcome.
4 secondary outcomes
Revised Child Anxiety and Depression Scale (RCADS) (self-and caregiver report)
Time frame: baseline, 4-month follow-up, 10-month follow-up
Screening and Promotion of Children and Adolescents Health: A European Public Health Perspective (KIDSCREEN questionnaire) (self-and caregiver report)
Time frame: baseline, 4-month follow-up, 10-month follow-up
Child and Adolescent Trauma Screen - Second Version (CATS-2 caregiver-report)
Time frame: baseline, 4-month follow-up, 10-month follow-up
Children's Global Assessment Scale (CGAS Caregiver-report)
Time frame: baseline, 4-month follow-up, 10-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Background: PubMed 35928521Sachser C, Berliner L, Risch E, Rosner R, Birkeland MS, Eilers R, Hafstad GS, Pfeiffer E, Plener PL, Jensen TK. The child and Adolescent Trauma Screen 2 (CATS-2) - validation of an instrument to measure DSM-5 and ICD-11 PTSD and complex PTSD in children and adolescents. Eur J Psychotraumatol. 2022 Aug 1;13(2):2105580. doi: 10.1080/20008066.2022.2105580. eCollection 2022.
- Background: PubMed 10937431Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.
- Background: PubMed 6639293Shaffer D, Gould MS, Brasic J, Ambrosini P, Fisher P, Bird H, Aluwahlia S. A children's global assessment scale (CGAS). Arch Gen Psychiatry. 1983 Nov;40(11):1228-31. doi: 10.1001/archpsyc.1983.01790100074010.
- Background: PubMed 33610177Waldmann T, Stiawa M, Dinc U, Saglam G, Busmann M, Daubmann A, Adema B, Wegscheider K, Wiegand-Grefe S, Kilian R. Costs of health and social services use in children of parents with mental illness. Child Adolesc Psychiatry Ment Health. 2021 Feb 20;15(1):10. doi: 10.1186/s13034-021-00360-y.
- Background: PubMed 25948489Ehrhart MG, Aarons GA, Farahnak LR. Going above and beyond for implementation: the development and validity testing of the Implementation Citizenship Behavior Scale (ICBS). Implement Sci. 2015 May 7;10:65. doi: 10.1186/s13012-015-0255-8.
- Background: PubMed 28372587Rye M, Torres EM, Friborg O, Skre I, Aarons GA. The Evidence-based Practice Attitude Scale-36 (EBPAS-36): a brief and pragmatic measure of attitudes to evidence-based practice validated in US and Norwegian samples. Implement Sci. 2017 Apr 4;12(1):44. doi: 10.1186/s13012-017-0573-0.
- Background: PubMed 29847849Bieda A, Pflug V, Scholten S, Lippert MW, Ladwig I, Nestoriuc Y, Schneider S. [Unwanted Side Effects in Children and Youth Psychotherapy - Introduction and Recommendations]. Psychother Psychosom Med Psychol. 2018 Sep;68(9-10):383-390. doi: 10.1055/s-0044-102291. Epub 2018 May 30. German.
- Derived from this study: PubMed 38898537Pfeiffer E, Dorrie L, Koksal J, Krech F, Muche R, Segler J, Sachser C. Evaluation of "Cognitive Behavioral Intervention for Trauma in Schools" (CBITS) in child welfare programs in Germany: study protocol of a randomized controlled trial. Trials. 2024 Jun 19;25(1):399. doi: 10.1186/s13063-024-08190-x.
- Individual participant dataSharing planned: Yes. Yes - Individual participant data (IPD) will be made available to other researchers on request, after publication of the main results and after data sharing agreements are concluded. All IPD that underlie results in a publication will be shared. The study protocol and statistical analysis plan will be shared. IPD and additional supporting information will become available for 2 years once summary data is published. Requests for IPD data and additional supporting information will be reviewed by the leaders of the project (E. Pfeiffer and C. Sachses). There is no web address about the plan to share IPD available.
Related trials for Posttraumatic Stress Disorder
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Recruiting
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Post-Traumatic Stress Disorder
RecruitingPhase 3
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
Major Depression
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Recruiting
Exercise and Emotional Learning in Posttraumatic Stress Disorder
PTSD
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.
Elisa Pfeiffer, PhD principal investigator
Ulm University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing CBITS and TAU+ in people with Posttraumatic Stress Disorder, run by University Hospital Ulm.
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 5 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 14 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Pfeiffer, PhD (+49 731 500 62658, CBITS.kjp@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and Adolescent Trauma Screen - Second Version (CATS-2 self-report) (time frame: baseline, 4-month follow-up, 10-month follow-up (primary endpoint 4-months follow up)). 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 NCT06038357, which also lists 8 linked publications.
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 14 Sep 2023.