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

L

LMU Klinikum

Status

Completed

Conditions

Stress Disorders, Post-Traumatic

Treatments

Behavioral: Intensive in-patient psychotherapy treatment
Other: Treatment as usual

Study type

Interventional

Funder types

Other

Identifiers

NCT03894774
MOSES

Details and patient eligibility

About

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)

Full 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;

Enrollment

57 patients

Sex

All

Ages

6 to 13 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

57 participants in 3 patient groups

Intensive InPatient Psychotherapy Treatment Group (IG)
Experimental group
Description:
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.
Treatment:
Behavioral: Intensive in-patient psychotherapy treatment
Waiting Control Group (WCG)
Active Comparator group
Description:
Treatment as usual (mostly combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy). Duration: At least 3 month to a maximum of 6 month.
Treatment:
Other: Treatment as usual
Healthy Control Group (HCG)
No Intervention group
Description:
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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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