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

Not Applicable

Recruiting

• Conditions: Post-traumatic Stress Disorder

• Registration Number: NCT06143982
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-10-05
• Status Verified: 2023-09
• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-11-16
• Last Update Submitted: 2023-11-16
• Study First Posted: 2023-11-22
• Last Update Posted: 2023-11-22
• Primary Completion: 2025-01-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Posttraumatic stress symptoms (KJTS)	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.	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.
Changes in Posttraumatic stress symptoms (CAPS-CA)	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.	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Anxiety symptoms (SCID-5-Junior)	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.	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.
Changes in Quality of life	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.	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.
Changes in Depression symptoms (SCID-5-Junior)	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.	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.
Dropout rates	Dropout is measures at each day of the BITT week (in total 5 days).	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).
Changes in Anxiety symptoms (PROMIS)	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.	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.
Changes in Depression symptoms (PROMIS)	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.	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.
Changes in Risk-behavior and safety	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.	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.
Cost-effectiveness	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.	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).
Changes in Anger symptoms (PROMIS)	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.	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.
Changes in Anger symptoms (SCID-5 Junior)	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.	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.

Trial Locations

Locations (3)

Mental Health Caribbean; 🇧🇶 Kralendijk, Bonaire, Sint Eustatius and Saba

Amsterdam UMC, location AMC/Levvel; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Karakter; 🇳🇱 Almelo, Overijsel, Netherlands