An interventional study of Brief Intensive Trauma Treatment in Post-traumatic Stress Disorder, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 3 sites in 2 countries. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
The primary objective of this study is to examine the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents with (s)PTSD.
This study is a multi-center, single-blinded RCT. Adolescents (12-18 years old) with (s)PTSD will be randomly allocated by an independent researcher to the BITT (n=50) versus a waitlist control group (WLCG; n=50), stratified by center. Measurements are done at comparable time intervals for both groups: at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up. The WLCG receives BITT after the 3 months follow-up.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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In order to be eligible to participate in this study, a subject must meet all of the following criteria:
at least subthreshold PTSD criteria, conform the CAPS-CA DSM-5, i.e.;
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study in case of:
If allocated to the intervention group, participants follow the Brief Intensive Trauma Treatment (BITT).
Behavioral: Brief Intensive Trauma Treatment
When allocated to the WLCG, participants receive BITT after a 3 months waiting period. The WLCG receives no care during the treatment phase (one week) of the intervention group. Besides this week the WLCG can undergo every treatment including EMDR and TF-CBT during the 3 months waiting period.
BITT is an outpatient, intensive, one-week individual trauma therapy program. BITT is based on well-established protocols, consisting of two 90-minutes trauma therapy sessions a day (trauma exposure in the morning and EMDR in the afternoon), two psychomotor therapy sessions a day (1x60 minutes, 1x45 minutes), one 90-minutes psycho-education and social support skill training for parents a day, and a 90-minutes family therapy session at the end of the week (sharing the trauma narrative).
Changes in Posttraumatic stress symptoms (CAPS-CA)
The primary objective of this study is to test the effectiveness of BITT versus a WLCG on adolescents (12-18 years) with (s)PTSD. PTSD symptoms will be assessed by the Clinician Administered PTSD Scale for Children and Adolescents DSM-5 (CAPS-CA DSM 5; Van Meijel et al., 2013). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on (s)PTSD symptoms will be tested.
Time frame: PTSD symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Posttraumatic stress symptoms (KJTS)
The primary objective of this study is to test the effectiveness of BITT versus a WLCG on adolescents (12-18 years) with (s)PTSD. PTSD symptoms will be assessed by the Child and Adolescent Trauma Screening (In Dutch: Kind en Jeugd Trauma Screener (KJTS; Kooij \& Lindauer, 2019). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on (s)PTSD symptoms will be tested.
Time frame: PTSD symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Anger symptoms (PROMIS)
The second objective is to test the effectiveness of BITT versus a WLCG on anger symptoms. Anger symptoms will be measures with the Patient-Reported Outcomes Measurement Information System (PROMIS; Terwee et al., 2014). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on anger will be tested.
Time frame: Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Anger symptoms (SCID-5 Junior)
Anger symptoms will also be measures with the Structured Clinical Interview for DSM-5 Childhood Disorders (SCID-5 Junior; module 12 Disruptive, impulse control and other behavioral disorders; Wante et al., 2020). The SCID-5 module will be administered when the adolescent scores T ≥ 60 on the PROMIS questionnaire.
Time frame: Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Anxiety symptoms (PROMIS)
The third objective is to test the effectiveness of BITT versus a WLCG on anxiety symptoms. Anxiety symptoms will be measures with the Patient-Reported Outcomes Measurement Information System (PROMIS; Terwee et al., 2014). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on anxiety will be tested.
Time frame: Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Anxiety symptoms (SCID-5-Junior)
Anxiety symptoms will also be measures with the Structured Clinical Interview for DSM-5 Childhood Disorders (SCID-5 Junior; Module 6 Anxiety disorder; Wante et al., 2020). The SCID-5 module will be administered when the adolescent scores T ≥ 60 on the PROMIS questionnaire.
Time frame: Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Depression symptoms (PROMIS)
The fourth objective is to test the effectiveness of BITT versus a WLCG on depression symptoms. Depression symptoms will be measures with the Patient-Reported Outcomes Measurement Information System (PROMIS; Terwee et al., 2014). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) depression symptoms will be tested.
Time frame: Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Depression symptoms (SCID-5-Junior)
Depression symptoms will also be measures with the Structured Clinical Interview for DSM-5 Childhood Disorders (SCID-5 Junior; Module 3 Depressive mood disorders; Wante et al., 2020). The SCID-5 module will be administered when the adolescent scores T ≥ 60 on the PROMIS questionnaire.
Time frame: Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Quality of life
The fifth objective of this study is to examine the effectiveness of BITT versus a WLCG on quality of life. Quality of life will be measures with the EuroQol-5D (EuroQol-Group, 2009). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on quality of life will be tested.
Time frame: Quality of life is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Changes in Risk-behavior and safety
The sixth objective is to test if BITT is a safe intervention. This will be measured with a risk-behavior and safety questionnaire based on previous work by Hendriks et al. (2017) regarding: self-harm, suicidality and aggressive behavior.
Time frame: Risk-behavior and safety is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Dropout rates
The seventh objective is to examine if BITT leads to less drop out rates. Drop outs will be documented in an Excel file (yes/no).
Time frame: Dropout is measures at each day of the BITT week (in total 5 days).
Cost-effectiveness
The eighth objective is to examine the cost-effectiveness of BITT. Cost-effectiveness will be measured with the Treatment Inventory of Costs in Psychiatric clients (TiC-PY/proxy) (Bouwmans et al., 2012).
Time frame: Cost-effectiveness is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Age (moderator)
Age will be studied as a moderator on the effectiveness of BITT on PTSD.
Time frame: Age is documented at pre-treatment (T0).
Sex (moderator)
Sex will be studied as a moderator on the effectiveness of BITT on PTSD.
Time frame: Sex is documented at pre-treatment (T0).
Socioeconomic status (SES; moderator)
SES will be studied as a moderator on the effectiveness of BITT on PTSD.
Time frame: SES is documented at pre-treatment (T0).
Type of trauma (moderator)
Type of trauma will be studied as a moderator on the effectiveness of BITT on PTSD. Type of trauma will be assessed with de CAPS-CA DSM-5 (Van Meijel et al., 2013).
Time frame: Type of trauma is measured at pre-treatment (T0).
Number of traumatic events (moderator)
Number of traumatic events will be studied as a moderator on the effectiveness of BITT on PTSD. Number of traumatic events will be assessed with the CAPS-CA DSM-5 (Van Meijel et al., 2013).
Time frame: Number of traumatic events is measured at pre-treatment (T0).
Comorbidity (anger symptoms; moderator)
Comorbidity (anger symptoms; moderator) will be studied as moderator on the effectiveness of BITT on PTSD. Anger will be assessed with the PROMIS (Terwee et al., 2014).
Time frame: Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Comorbidity (anxiety symptoms moderator)
Comorbidity (anxiety symptoms; moderator) will be studied as moderator on the effectiveness of BITT on PTSD. Anxiety symptoms will be assessed with the PROMIS (Terwee et al., 2014).
Time frame: Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Comorbidity (depression symptoms; moderator)
Comorbidity (depression symptoms; moderator) will be studied as moderator on the effectiveness of BITT on PTSD. Depression symptoms will be assessed with the PROMIS (Terwee et al., 2014).
Time frame: Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Parental PTSD (moderator)
Parental PTSD will be studied as a moderator on the effectiveness of BITT on PTSD. Parental PTSD will be assessed with the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) (Blevins et al., 2015).
Time frame: Parental PTSD is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Treatment center (Participating centers: Levvel/Karakter/Mental Health Caribbean; moderator)
Treatment center (Levvel, Karakter, Mental Health Caribbean) will be studied as a moderator on the effectiveness of BITT on PTSD.
Time frame: Treatment center (Levvel, Karakter, Mental Health Caribbean) is documented at pre-treatment (T0).
Residency (urban/rural; moderator)
Residency (urban/rural) will be studied as a moderator on BITT dropout.
Time frame: Residency is documented at pre-treatment (T0).
Ethnicity
Ethnicity will be studied as a moderator on BITT dropout.
Time frame: Ethnicity is documented at pre-treatment (T0).
Plan to share: No
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