1. Examine the physiological, endocrinological and neural differences between children with PTSD and without PTSD2. Examine if neurobiological treatment effects of TF-CBT and EMDR differ and if so how3. Examine if neurobiological treatment effects…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neuroimaging: (f)MRI, DTI,
Physiological measures: Heartrate(variability), Skin conductance
Endocrinological measures: Cortisolconcentration in saliva
Secondary outcome
CAPS-CA (interview to help diagnose PTSD)
ADIS (interview to screen for anxiety disorders)
cPTCI, RCADS, CRIES, SDQ, Kidscreen
Background summary
Every day, children suffer from assault, sexual abuse, natural disasters,
accidents or other traumatic events. The prevalence of traumatic events in
children is high. While most children will recover from exposure to a traumatic
event without developing a post-traumatic stress disorder (PTSD) a significant
minority (10 up to 35 percent) will develop PTSD in the aftermath of a
traumatic event. PTSD is a disabling and often chronic anxiety disorder which
has short and long term negative influences on (mental) health, social life and
academic functioning. When a child develops PTSD, effective treatment is
essential. Trauma focused cognitive behavioral therapy (TF-CBT) and EMDR have
shown promising results in children. Most children benefit from psychotherapy
but a substantial part of children does not demonstrate symptom remission
during the course of treatment. There is insufficient insight in the mechanisms
which are involved in the development of PTSD and treatment response. These
insights can help to indentify children who are at risk of developing PTSD,
improve precision of referrals and improve treatment strategies, especially for
treatment non responders. Research in adults has shown that PTSD and response
to psychotherapy are associated with changes in neural circuitry involving
frontal and limbic structures. Furthermore changes in the hypothalamus
pituitary adrenal (HPA) axis and autonomous nervous system (ANS) have been
found. These results are however not easily extrapolated to children and
adolescents mainly because these neurobiological systems are still fully
developing during childhood and adolescence and do not reach functional
maturity before adulthood. Therefore studies using neurobiological measures in
children with PTSD are warranted.
Study objective
1. Examine the physiological, endocrinological and neural differences between
children with PTSD and without PTSD
2. Examine if neurobiological treatment effects of TF-CBT and EMDR differ and
if so how
3. Examine if neurobiological treatment effects are maintained over a longer
period of time
4. Examine the relationship between psychometric, neuroimaging, physiological
and endocrinological measurements
5. Examine if neurobiological measures can be used to predict treatment
response and relapse after treatment
Study design
This project consists of two consecutive parts: One part is a cross-sectional
comparison between children who are exposed to a traumatic experience without
developing PTSD and children who do develop PTSD. The following neurobiological
measures will be conducted: neuroimaging, endocrinological and physiological
measurements.
In a longitudinal part we will administer the above mentioned biological
measures only to the participants with PTSD. We will utilize a PROBE design
(prospective randomized open label blinded endpoint). Measurements will be
conducted at three time points; three months after the most recent traumatic
experience (before treatment has started), after completion of treatment and
six months post-treatment. Each measurement point consists of two appointments,
one for the physiological measures and one for the neuroimaging procedure.
Intervention
Participants with PTSD will randomly be assigned to one of the following to
treatments as part of the study by Diehle (MEC 09/076). For both treatment
conditions 8 sessions of 60 minutes will be implemented.
TF-CBT: The components included in the protocol for TF-CBT are: psychoeducation
and Parenting skills; Relaxation; Affective modulation; Cognitive coping and
processing; Trauma narrative; In vivo mastery of trauma reminders; Conjoint
child-parent sessions; Enhancing future safety and development.
EMDR: The following components are included in the protocols: psychoeducation
and preparation; assessment; desensitization; installation; body scan; positive
closure and enhancing future safety.
Study burden and risks
Participation in the study does not hold any risks. However, subjects have to
spent time to participate in the study. For traumatized controls this means
spending 3,5 hours in the study; children with PTSD will spend 6 hours in
participation. For children with PTSD, the time consumed will be kept low by
combining appointments for research participation with appointments they have
in the scope of the regular patient care at De Bascule. This eliminates time
spent travelling.
Meibergdreef 5
1105 AZ Amsterdam ZO
NL
Meibergdreef 5
1105 AZ Amsterdam ZO
NL
Listed location countries
Age
Inclusion criteria
Involvement in at least one traumatic event
Age 8 through 17 years
Exclusion criteria
- Acute suicidal
- Mental disorders due to a general medical condition
- Meeting the criteria of one of the following DSM IV TR-diagnosis: psychotic disorder, substance use disorder, pervasive develop disorder (e.g. autism), mental retardation
- Known presence of a significant medical illness including cardiac arrhythmias and epilepsia
- Pregnancy
- Gross obesity (weight greater than 150% of ideal body weight) or growth failure (height under 3rd percentile)
- The use or presence of medication with central nervous system or HPA axis effects within the 2 weeks before measures
- Claustrophobia
- Presence of any metal or electrical conductive implants or foreign bodies
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL35971.018.11 |