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

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

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

Study Overview

• Status: Recruiting
• Conditions: Post-traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Brief Intensive Trauma Treatment

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Myrna Westerveld, MSc; Phone Number: +31643300014; Email: m.m.westerveld@amsterdamumc.nl
• Study Contact Backup: Name: Malindi van der Mheen, Dr.; Phone Number: +31205663383; Email: m.vandermheen@levvel.nl

Study Locations

• Bonaire, Sint Eustatius and Saba
  • Kralendijk, Bonaire, Sint Eustatius and Saba
    • Recruiting
    • Mental Health Caribbean
    • Contact: Marielle Hoekstra, MSc; Phone Number: +599-7170125; Email: marielle.hoekstra@mentalhealthcaribbean.com
• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Recruiting
      • Amsterdam UMC, location AMC/Levvel
      • Contact: Myrna Westerveld, MSc; Phone Number: +31643300014; Email: m.m.westerveld@amsterdamumc.nl
  • Overijsel
    • Almelo, Overijsel, Netherlands, 7600 AP
      • Recruiting
      • Karakter
      • Contact: Rik Knipschild,, MSc; Phone Number: 31629607864; Email: r.knipschild@karakter.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Intensive Trauma Treatment; If allocated to the intervention group, participants follow the Brief Intensive Trauma Treatment (BITT).	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).
No Intervention: Waitlist control group; 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?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age (moderator)	Age will be studied as a moderator on the effectiveness of BITT on PTSD.	Age is documented at pre-treatment (T0).
Sex (moderator)	Sex will be studied as a moderator on the effectiveness of BITT on PTSD.	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.	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).	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).	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).	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).	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).	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).	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.	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.	Residency is documented at pre-treatment (T0).
Ethnicity	Ethnicity will be studied as a moderator on BITT dropout.	Ethnicity is documented at pre-treatment (T0).

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Ramón Lindauer, Prof. dr., Amsterdam UMC, location AMC/Levvel

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Estimated): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; PTSD; Trauma; Intensive treatment; BITT
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: Effectstudie BITT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No