Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (s)PTSD: a Multi-center RCT

Study Overview
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Brief Summary
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The primary objective of this study is to examine the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents with (s)PTSD.

Detailed Description
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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.

Official Title
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Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (Subclinical) PTSD: a Multi-center Randomized Controlled Trial

Conditions
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Post-traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Brief Intensive Trauma Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 12-18 years of age; with a history of psychological trauma (conform the Life Events Checklist of the Clinician Administered PTSD Scale for Children and Adolescents DSM-5 (CAPS-CA DSM-5) (Nader, 2004; van Meijel et al., 2019); at least subthreshold PTSD criteria, conform the CAPS-CA DSM-5, i.e.; fully meeting criterion A, F and G and at least one symptom of criteria B, C, D and E; or fully meeting criterion A, F, G and at least the B, C, D or E symptom clusters; and written informed consent must be provided by the adolescent and, for adolescents aged 12-15 years, all legal guardians. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study in case of: inability to speak and write Dutch; estimated or determined mental retardation (IQ <70); suffering from ongoing trauma by a parent who is part of the adolescent's current primary-care system.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A two-arm, mutli-center, randomized controlled trial (RCT). Adolescents (12-18 years old) with (s)PTSD will be randomly allocated by an independent researcher to the intervention group (n=50) versus a waitlist control group (WLCG; n=50), stratified by center. If allocated to the intervention group, participants follow the Brief Intensive Trauma Treatment (BITT). When allocated to the WLCG, participants receive BITT after a 3 months waiting period. 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Intensive Trauma Treatment<br>If allocated to the intervention group, participants follow the Brief Intensive Trauma Treatment (BITT). | Behavioral: Brief Intensive Trauma Treatment<br>* 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).<br>|
| No Intervention: Waitlist control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Trauma, Intensive treatment, BITT, Adolescents