Stress Disorders, Post-TraumaticMOSESNCT03894774
Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children (MOSES)
A study testing Intensive in-patient psychotherapy treatment and Treatment as usual in people with Stress Disorders, Post-Traumatic, run by LMU Klinikum at 1 site in Germany.
Trial summary
Evaluation of longitudinal treatment effects applying an intensive psychotherapeutic intervention for inpatients (age of participants: 6-13 years) with a multi-method-approach to address the complex nature of severe childhood trauma. (Chronic Post-Traumatic Stress Disorder) Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Intensive in-patient psychotherapy 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
- 57 participants
- Where
- 1 siteGermany
- Study dates
- 5 Dec 2012to 31 Aug 2019
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Severe early traumatization with experiences of violence, neglect, abuse and chronic symptoms related to complex PTSD.
Who cannot join
- Autism spectrum disorder
- Addiction disorder
- Mental disability (IQ < 85)
- Endangerment to themselves or others
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich
Munich, 80337
About this study
Official title: Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children - Clinical Pilot Study Including Multimodal Mri (MOSES)
Evaluation of longitudinal treatment effects applying an intensive psychotherapeutic intervention for inpatients (age of participants: 6-13 years) with a multi-method-approach to address the complex nature of severe childhood trauma. (Chronic Post-Traumatic Stress Disorder)
Read the detailed description
Severe adversity and trauma in early childhood have been associated with a highly increased risk for a variety of psychiatric disorders, lasting into adulthood. This increased risk is accompanied by a set of biological changes ranging from changes in cortical thickness to endocrinological changes. At a behavioral level, children with complex PTSD (developmental trauma disorder) show severe and long-lasting negative effects. Such children exhibit a wide range of symptoms: affect dysregulation, attention difficulties, impairment in interpersonal relationships, aggressive and dissociative behaviour, disturbances of cognition. Corresponding alterations in neural networking and brain development are well studied. Although evidence-based treatment approaches for children with non-complex PTSD exist, complex-traumatized children have no well-evaluated treatments. Furthermore, early intervention can prevent the chronification and exacerbation of symptoms and promote social adaptation and participation.The following topics will be addressed: (1) brain development (Multimodal MRI (mMRI) including anatomical (T1-MPRAGE, T2-FLAIR, DTI-Diffusion Tensor Imaging) and functional MRI measurements (resting-state functional MRI, task fMRI (presenting affective pictures according to the International Affective Picture System, IAPS), EEG); (2) alterations in neuroendocrinological systems involved in stress regulation (Cortisol, Oxytocin, Vasopressin); (3) behavioral symptoms; (4) cognitive functioning; (5) attachment representations of children and their primary caregivers;
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Intensive in-patient psychotherapy treatment, Treatment as usual
- Keywords
- Chronic Post-Traumatic Stress Disorder, Neuroses, Posttraumatic, PTSD
- 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.
Intensive in-patient psychotherapy treatmentBehavioural
Intensive non-pharmaceutical in-patient intervention with high degrees of individual psychotherapy (5 sessions a week, psychodynamic and specific trauma therapy), group therapy (music-, arts-, sports- and concentrative movement therapy - each one session a week) as well as an ongoing milieutherapeutic setting where patients live during the whole treatment (approximately a 1:1-Ratio caregiver per patient is given) of 6 to 8 month treatment duration.
Treatment as usualOther
Combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intensive InPatient Psychotherapy Treatment Group (IG) | Experimental | Intensive non-pharmaceutical inpatient intervention with high degrees of individual psychotherapy (5 sessions a week, psychodynamic and specific trauma therapy), group therapy (music-, arts-, sports- and concentrative movement therapy - each one session a week) as well as an ongoing milieutherapeutic frame where patients live over the whole treatment (approximately a 1:1-ratio caregiver per patient is given) of 6 to 8 month treatment duration. Receives: Behavioral: Intensive in-patient psychotherapy treatment |
| Waiting Control Group (WCG) | Active comparator | Treatment as usual (mostly combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy).
Duration: At least 3 month to a maximum of 6 month. Receives: Other: Treatment as usual |
| Healthy Control Group (HCG) | No intervention | Matched Pairs design to control for gender, age and handedness. HCG measurements are planned and conducted according to the exact durations of their matched inpatient pair of the IG. Mandatory to control for effects of factors such as brain maturation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural MRI (T1w, T2w, DTI)
All structural images will be acquired in a 3 Tesla MR system using a 20- channel head-coil (Siemens, Erlangen). Data post-processing will be performed with lab-internal scripts developed for a multi-core cluster. For structural analyses of T1w, T2w and DTI data, freesurfer,FSL and workbench will be used. T1w and T2w data will be volumetrically analyzed and the results will be reported in mm3. DTI data will be processed using tbss-FSL and probtrackX-FSL. DTI will be quantified in regard of the number of white matter fiber bundles within regions-of-interest (ROIs) and from-ROI-to-ROI. The Dosenbach atlas (Dosenbach et al. 2010) and the multimodal Brainetome atlas (Fan et al. 2016) will be used for all structural analyses. It is an explorative study that follows a whole-brain approach. Changes in emotion-processing and trauma-associated brain regions such as the hippocampus,the amygdala,the orbitofrontal cortex and the insula are assumed
Measured: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Resting state functional MRI connectivity (rsfcMRI)
EPI-sequence: fMRI will be carried out at 3 Tesla (Siemens) scanner using a 20- channel head-coil. For functional imaging, an EPI sequence with the following parameters will be used: repetition time (TR),2000 ms; echo time (TE),30 ms; flip angle (FA), 80°; spatial resolution, 3 × 3 × 3 mm3; imaging matrix, 64 × 64; field-of-view (FoV), 192 × 192 mm2; number of slices: 36; number of volumes: 200. Data post-processing will be performed with lab-internal scripts developed for a multicore cluster. For rsfcMRI analyses of freesurfer,FSL,AFNI and workbench will be used. rsfcMRI will be quantified as number of significant activated voxels (spatial extent) and connectivity strength (z-scores).Networks of interest (ICA-based): Salience network, Default Mode Network. Regions of interest (seed-based): hippocampus, the amygdala, the orbitofrontal cortex and the insula.In addition, a RS-EEG with 19 scalp electrodes is used to complement rsfcMRI,which is cortically evaluated using Brainstorm.
Measured: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Task-based fMRI using the International affective picture system (IAPS)
For the task-based fMRI the same EPI sequence will be used as for the resting state (see outcome 2). The number of volumes: 180. Three different sets of each 45 (15 neutral, 15 negative, 15 positive rated pictures) pictures were created and randomly displayed during the scanning procedure and also afterward to control for personal affective valence and arousal with Self-Assessment Manikin (SAM).
Data post-processing will be performed with FSL-FEAT using a block-design. Regions of interest follow the previous structural and rsfcMRI analyses ROIs: hippocampus, amygdala, orbitofrontal cortex and the insula.
Measured: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Secondary outcomes (3)
Alterations in neuroendocrinological systems involved in stress regulation
Oxytocin (pg/ml in Saliva) release of active stress regulation throughout relaxation using attachment interviews as stressors. Oxytocin will be analysed using radioimmunoassays in an external lab (Landgraf Riagnosis, MPI).
Measured: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Alterations in neuroendocrinological systems involved in stress regulation 2
Cortisol (ng/mL in Saliva) release in active stress regulation throughout relaxation using attachment interviews as stressors. Cortisol will be analysed by Endocrine Laboratories, Department of Medicine IV, University Hospital, LMU Munich.
Measured: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Alterations in neuroendocrinological systems involved in stress regulation 3
Vasopressin (pg/ml in Saliva) release of active stress regulation throughout relaxation using attachment interviews as stressors. Vasopressin will be analysed using radioimmunoassays in an external lab (Landgraf Riagnosis, MPI).
Measured: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start5 Dec 2012
- Primary completion17 Oct 2017
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Non-randomised
- Intervention model
- Factorial
- Model description
- The study was conducted in the following randomized waiting control design: After being included in the study at time T0 the children stay in Treatment-As-Usual (TAU) for at least three months and are then randomly assigned to the Intensive Inpatient Psychotherapy Treatment Group (IG) or the Waiting Control Group (WCG) after this TAU time period (This period is considered necessary and sufficient in order to reliably estimate possible trends of changes in the brain). The children in the WCG stay in TAU and are assigned to the IG as soon as a treatment place is available. The waiting period will be included in the analysis as a confounder. The third group is a Healthy Control Group (HCG) of matched pairs (matched for gender, age and handedness).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Collaborators
- Max-Planck-Institute of Psychiatry
- Responsible party
- Principal investigator, Karl H Brisch, LMU Klinikum
- Investigators
- Ludwig Ebeling, M.A., Principal investigator, Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU MunichCatherina Dehmel, M.sc., Principal investigator, Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU MunichLukas Oberschneider, MD, Principal investigator, Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894774
- Sponsor's protocol ID
- MOSES
- Acronym
- MOSES
- Status last verified
- Feb 2020
- First submitted
- 19 Dec 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD concerning MRI analysis. Individual participant data set.
Publications
Heim C, Binder EB. Current research trends in early life stress and depression: review of human studies on sensitive periods, gene-environment interactions, and epigenetics. Exp Neurol. 2012 Jan;233(1):102-11. doi: 10.1016/j.expneurol.2011.10.032. Epub 2011 Nov 7.
PubMed 22101006Hamilton, L., Micol-Foster, V., & Muzik, M. Childhood maltreatment trauma: Relevance for adult physical and emotional health. A Review. Trauma Cases and Reviews, 1(003), 2015.
D'Andrea W, Ford J, Stolbach B, Spinazzola J, van der Kolk BA. Understanding interpersonal trauma in children: why we need a developmentally appropriate trauma diagnosis. Am J Orthopsychiatry. 2012 Apr;82(2):187-200. doi: 10.1111/j.1939-0025.2012.01154.x.
PubMed 22506521Pechtel P, Pizzagalli DA. Effects of early life stress on cognitive and affective function: an integrated review of human literature. Psychopharmacology (Berl). 2011 Mar;214(1):55-70. doi: 10.1007/s00213-010-2009-2. Epub 2010 Sep 24.
PubMed 20865251Teicher MH, Samson JA, Anderson CM, Ohashi K. The effects of childhood maltreatment on brain structure, function and connectivity. Nat Rev Neurosci. 2016 Sep 19;17(10):652-66. doi: 10.1038/nrn.2016.111.
PubMed 27640984Gold AL, Sheridan MA, Peverill M, Busso DS, Lambert HK, Alves S, Pine DS, McLaughlin KA. Childhood abuse and reduced cortical thickness in brain regions involved in emotional processing. J Child Psychol Psychiatry. 2016 Oct;57(10):1154-64. doi: 10.1111/jcpp.12630.
PubMed 27647051Gillies D, Taylor F, Gray C, O'Brien L, D'Abrew N. Psychological therapies for the treatment of post-traumatic stress disorder in children and adolescents (Review). Evid Based Child Health. 2013 May;8(3):1004-116. doi: 10.1002/ebch.1916.
PubMed 23877914
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children - Clinical Pilot Study Including Multimodal Mri (MOSES)
- ClinicalTrials.gov ID
- NCT03894774
- Acronym / sponsor ID
- MOSES / MOSES
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Chronic Post-Traumatic Stress Disorder, Neuroses, Posttraumatic, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Collaborators
- Max-Planck-Institute of Psychiatry
- Study start
- 5 Dec 2012 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 29 Mar 2019 (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.
Evaluation of longitudinal treatment effects applying an intensive psychotherapeutic intervention for inpatients (age of participants: 6-13 years) with a multi-method-approach to address the complex nature of severe childhood trauma. (Chronic Post-Traumatic Stress Disorder)
Detailed description
Severe adversity and trauma in early childhood have been associated with a highly increased risk for a variety of psychiatric disorders, lasting into adulthood. This increased risk is accompanied by a set of biological changes ranging from changes in cortical thickness to endocrinological changes. At a behavioral level, children with complex PTSD (developmental trauma disorder) show severe and long-lasting negative effects. Such children exhibit a wide range of symptoms: affect dysregulation, attention difficulties, impairment in interpersonal relationships, aggressive and dissociative behaviour, disturbances of cognition. Corresponding alterations in neural networking and brain development are well studied. Although evidence-based treatment approaches for children with non-complex PTSD exist, complex-traumatized children have no well-evaluated treatments. Furthermore, early intervention can prevent the chronification and exacerbation of symptoms and promote social adaptation and participation.The following topics will be addressed: (1) brain development (Multimodal MRI (mMRI) including anatomical (T1-MPRAGE, T2-FLAIR, DTI-Diffusion Tensor Imaging) and functional MRI measurements (resting-state functional MRI, task fMRI (presenting affective pictures according to the International Affective Picture System, IAPS), EEG); (2) alterations in neuroendocrinological systems involved in stress regulation (Cortisol, Oxytocin, Vasopressin); (3) behavioral symptoms; (4) cognitive functioning; (5) attachment representations of children and their primary caregivers;
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The study was conducted in the following randomized waiting control design: After being included in the study at time T0 the children stay in Treatment-As-Usual (TAU) for at least three months and are then randomly assigned to the Intensive Inpatient Psychotherapy Treatment Group (IG) or the Waiting Control Group (WCG) after this TAU time period (This period is considered necessary and sufficient in order to reliably estimate possible trends of changes in the brain). The children in the WCG stay in TAU and are assigned to the IG as soon as a treatment place is available. The waiting period will be included in the analysis as a confounder. The third group is a Healthy Control Group (HCG) of matched pairs (matched for gender, age and handedness).
| Arm | Type | Receives |
|---|---|---|
| Intensive InPatient Psychotherapy Treatment Group (IG) | Experimental | Behavioral: Intensive in-patient psychotherapy treatmentIntensive non-pharmaceutical inpatient intervention with high degrees of individual psychotherapy (5 sessions a week, psychodynamic and specific trauma therapy), group therapy (music-, arts-, sports- and concentrative movement therapy - each one session a week) as well as an ongoing milieutherapeutic frame where patients live over the whole treatment (approximately a 1:1-ratio caregiver per patient is given) of 6 to 8 month treatment duration. |
| Waiting Control Group (WCG) | Active comparator | Other: Treatment as usualTreatment as usual (mostly combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy). Duration: At least 3 month to a maximum of 6 month. |
| Healthy Control Group (HCG) | No intervention | –Matched Pairs design to control for gender, age and handedness. HCG measurements are planned and conducted according to the exact durations of their matched inpatient pair of the IG. Mandatory to control for effects of factors such as brain maturation. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Severe early traumatization with experiences of violence, neglect, abuse and chronic symptoms related to complex PTSD.
Key exclusion criteria (4 listed)
- Autism spectrum disorder
- Addiction disorder
- Mental disability (IQ < 85)
- Endangerment to themselves or others
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 in-patient psychotherapy treatmentIntensive non-pharmaceutical in-patient intervention with high degrees of individual psychotherapy (5 sessions a week, psychodynamic and specific trauma therapy), group therapy (music-, arts-, sports- and concentrative movement therapy - each one session a week) as well as an ongoing milieutherapeutic setting where patients live during the whole treatment (approximately a 1:1-Ratio caregiver per patient is given) of 6 to 8 month treatment duration. | Behavioural | Intensive InPatient Psychotherapy Treatment Group (IG) |
| Treatment as usualCombination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy | Other | Waiting Control Group (WCG) |
Primary outcome
Structural MRI (T1w, T2w, DTI)
Time frame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
All structural images will be acquired in a 3 Tesla MR system using a 20- channel head-coil (Siemens, Erlangen). Data post-processing will be performed with lab-internal scripts developed for a multi-core cluster. For structural analyses of T1w, T2w and DTI data, freesurfer,FSL and workbench will be used. T1w and T2w data will be volumetrically analyzed and the results will be reported in mm3. DTI data will be processed using tbss-FSL and probtrackX-FSL. DTI will be quantified in regard of the number of white matter fiber bundles within regions-of-interest (ROIs) and from-ROI-to-ROI. The Dosenbach atlas (Dosenbach et al. 2010) and the multimodal Brainetome atlas (Fan et al. 2016) will be used for all structural analyses. It is an explorative study that follows a whole-brain approach. Changes in emotion-processing and trauma-associated brain regions such as the hippocampus,the amygdala,the orbitofrontal cortex and the insula are assumed
Resting state functional MRI connectivity (rsfcMRI)
Time frame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
EPI-sequence: fMRI will be carried out at 3 Tesla (Siemens) scanner using a 20- channel head-coil. For functional imaging, an EPI sequence with the following parameters will be used: repetition time (TR),2000 ms; echo time (TE),30 ms; flip angle (FA), 80°; spatial resolution, 3 × 3 × 3 mm3; imaging matrix, 64 × 64; field-of-view (FoV), 192 × 192 mm2; number of slices: 36; number of volumes: 200. Data post-processing will be performed with lab-internal scripts developed for a multicore cluster. For rsfcMRI analyses of freesurfer,FSL,AFNI and workbench will be used. rsfcMRI will be quantified as number of significant activated voxels (spatial extent) and connectivity strength (z-scores).Networks of interest (ICA-based): Salience network, Default Mode Network. Regions of interest (seed-based): hippocampus, the amygdala, the orbitofrontal cortex and the insula.In addition, a RS-EEG with 19 scalp electrodes is used to complement rsfcMRI,which is cortically evaluated using Brainstorm.
Task-based fMRI using the International affective picture system (IAPS)
Time frame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
For the task-based fMRI the same EPI sequence will be used as for the resting state (see outcome 2). The number of volumes: 180. Three different sets of each 45 (15 neutral, 15 negative, 15 positive rated pictures) pictures were created and randomly displayed during the scanning procedure and also afterward to control for personal affective valence and arousal with Self-Assessment Manikin (SAM). Data post-processing will be performed with FSL-FEAT using a block-design. Regions of interest follow the previous structural and rsfcMRI analyses ROIs: hippocampus, amygdala, orbitofrontal cortex and the insula.
3 secondary outcomes
Alterations in neuroendocrinological systems involved in stress regulation
Time frame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Alterations in neuroendocrinological systems involved in stress regulation 2
Time frame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Alterations in neuroendocrinological systems involved in stress regulation 3
Time frame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 22101006Heim C, Binder EB. Current research trends in early life stress and depression: review of human studies on sensitive periods, gene-environment interactions, and epigenetics. Exp Neurol. 2012 Jan;233(1):102-11. doi: 10.1016/j.expneurol.2011.10.032. Epub 2011 Nov 7.
- BackgroundHamilton, L., Micol-Foster, V., & Muzik, M. Childhood maltreatment trauma: Relevance for adult physical and emotional health. A Review. Trauma Cases and Reviews, 1(003), 2015.
- Background: PubMed 22506521D'Andrea W, Ford J, Stolbach B, Spinazzola J, van der Kolk BA. Understanding interpersonal trauma in children: why we need a developmentally appropriate trauma diagnosis. Am J Orthopsychiatry. 2012 Apr;82(2):187-200. doi: 10.1111/j.1939-0025.2012.01154.x.
- Background: PubMed 20865251Pechtel P, Pizzagalli DA. Effects of early life stress on cognitive and affective function: an integrated review of human literature. Psychopharmacology (Berl). 2011 Mar;214(1):55-70. doi: 10.1007/s00213-010-2009-2. Epub 2010 Sep 24.
- Background: PubMed 27640984Teicher MH, Samson JA, Anderson CM, Ohashi K. The effects of childhood maltreatment on brain structure, function and connectivity. Nat Rev Neurosci. 2016 Sep 19;17(10):652-66. doi: 10.1038/nrn.2016.111.
- Background: PubMed 27647051Gold AL, Sheridan MA, Peverill M, Busso DS, Lambert HK, Alves S, Pine DS, McLaughlin KA. Childhood abuse and reduced cortical thickness in brain regions involved in emotional processing. J Child Psychol Psychiatry. 2016 Oct;57(10):1154-64. doi: 10.1111/jcpp.12630.
- Background: PubMed 23877914Gillies D, Taylor F, Gray C, O'Brien L, D'Abrew N. Psychological therapies for the treatment of post-traumatic stress disorder in children and adolescents (Review). Evid Based Child Health. 2013 May;8(3):1004-116. doi: 10.1002/ebch.1916.
- Individual participant dataSharing planned: Yes. All collected IPD concerning MRI analysis. Individual participant data set.
Related trials for Stress Disorders, Post-Traumatic
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Ludwig Ebeling, M.A. principal investigator
Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich
Catherina Dehmel, M.sc. principal investigator
Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich
Lukas Oberschneider, MD principal investigator
Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive in-patient psychotherapy treatment and Treatment as usual in people with Stress Disorders, Post-Traumatic, run by LMU Klinikum at 1 site in Germany.
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 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: finished, as of the sponsor's last update on 20 Feb 2020. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural MRI (T1w, T2w, DTI) (time frame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)). The study lists 3 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 NCT03894774, which also lists 7 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 20 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.