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

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143982
• Other study ID #: Effectstudie BITT
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: February 1, 2026

Study information

• Verified date: September 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Myrna Westerveld, MSc
• Phone: +31643300014
• Email: m.m.westerveld[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Brief Intensive Trauma Treatment
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).

Locations

Country	Name	City	State
Bonaire, Sint Eustatius and Saba	Mental Health Caribbean	Kralendijk
Netherlands	Karakter	Almelo	Overijsel
Netherlands	Amsterdam UMC, location AMC/Levvel	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Countries where clinical trial is conducted

Bonaire, Sint Eustatius and Saba,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age (moderator)	Age will be studied as a moderator on the effectiveness of BITT on PTSD.	Age is documented at pre-treatment (T0).
Other	Sex (moderator)	Sex will be studied as a moderator on the effectiveness of BITT on PTSD.	Sex is documented at pre-treatment (T0).
Other	Socioeconomic status (SES; moderator)	SES will be studied as a moderator on the effectiveness of BITT on PTSD.	SES is documented at pre-treatment (T0).
Other	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).	Type of trauma is measured at pre-treatment (T0).
Other	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).	Number of traumatic events is measured at pre-treatment (T0).
Other	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).	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.
Other	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).	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.
Other	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).	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.
Other	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).	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.
Other	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.	Treatment center (Levvel, Karakter, Mental Health Caribbean) is documented at pre-treatment (T0).
Other	Residency (urban/rural; moderator)	Residency (urban/rural) will be studied as a moderator on BITT dropout.	Residency is documented at pre-treatment (T0).
Other	Ethnicity	Ethnicity will be studied as a moderator on BITT dropout.	Ethnicity is documented at pre-treatment (T0).
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.