Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children (MOSES)

NCT03894774 | Completed

• 1 other identifier: MOSES
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Stress Disorders, Post-Traumatic

Keywords

Chronic Post-Traumatic Stress Disorder; Neuroses, Posttraumatic; PTSD

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  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

  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

  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

  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)

Other Outcomes (11)

• Behavioral Symptoms 1: Child Behaviour Checklist (CBCL)

  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)

• Behavioral Symptoms 2: Child Behaviour Checklist (CBCL)

  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)

• Behavioral Symptoms 3: Child Behaviour Checklist (CBCL)

  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)

Study Arms (3)

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.

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.

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.

Interventions

Intensive in-patient psychotherapy treatment BEHAVIORAL

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.

Intensive InPatient Psychotherapy Treatment Group (IG)

Treatment as usual OTHER

Combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy

Waiting Control Group (WCG)

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Severe early traumatization with experiences of violence, neglect, abuse and chronic symptoms related to complex PTSD.

You may not qualify if:

• Autism spectrum disorder
• Addiction disorder
• Mental disability (IQ \< 85)
• Endangerment to themselves or others

Sponsors & Collaborators

• LMU Klinikum: lead
• Max-Planck-Institute of Psychiatry: collaborator

Study Sites (1)

Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich

Munich, 80337, Germany

Location

Related Publications (7)

• 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.

  PMID: 22101006 BACKGROUND

• Hamilton, 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

• 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.

  PMID: 22506521 BACKGROUND

• Pechtel 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.

  PMID: 20865251 BACKGROUND

• Teicher 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.

  PMID: 27640984 BACKGROUND

• Gold 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.

  PMID: 27647051 BACKGROUND

• Gillies 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.

  PMID: 23877914 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Ludwig Ebeling, M.A.

  Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich

  PRINCIPAL INVESTIGATOR

• Catherina Dehmel, M.sc.

  Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich

  PRINCIPAL INVESTIGATOR

• Lukas Oberschneider, MD

  Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pseudonymization at first stage of the intervention. Additional anonymization for all outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Pediatric Psychosomatic Medicin and Psychotherapy

Model Details: 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).

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: March 29, 2019
• Study Start: December 5, 2012
• Primary Completion: October 17, 2017
• Study Completion: August 31, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: 2019-2020
• Access Criteria: MRI analyses

Locations

DE (1)