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

NCT06143982 | Unknown

• 1 other identifier: Effectstudie BITT
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

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.

Conditions

Post-traumatic Stress Disorder

Keywords

PTSD; Trauma; Intensive treatment; BITT; Adolescents

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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.

• 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.

• 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.

• 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.

• 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.

Other Outcomes (12)

• Age (moderator)

  Age is documented at pre-treatment (T0).

• Sex (moderator)

  Sex is documented at pre-treatment (T0).

• Socioeconomic status (SES; moderator)

  SES is documented at pre-treatment (T0).

Study Arms (2)

Brief Intensive Trauma Treatment

EXPERIMENTAL

If allocated to the intervention group, participants follow the Brief Intensive Trauma Treatment (BITT).

Behavioral: Brief Intensive Trauma Treatment

Waitlist control group

NO INTERVENTION

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.

Interventions

Brief Intensive Trauma Treatment BEHAVIORAL

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).

Brief Intensive Trauma Treatment

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (3)

Mental Health Caribbean

Kralendijk, Bonaire, Saint Eustatius and Saba

RECRUITING

Amsterdam UMC, location AMC/Levvel

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Karakter

Almelo, Overijsel, 7600 AP, Netherlands

RECRUITING

Related Publications (1)

• Westerveld MM, van der Mheen M, Knipschild R, Maijer K, de Keizer-Altink ME, Albisser N, Hoekstra MJE, Timmermans-Jansen A, Zijp R, Krabbendam AA, van Steensel FJAB, Kan KJ, Huyser C, Staal WG, Utens EMWJ, Lindauer RJL. Short- and Long-Term Effectiveness of Brief Intensive Trauma Treatment for Adolescents With Posttraumatic Stress Disorder and Their Caregivers: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 30;14:e66115. doi: 10.2196/66115.

  PMID: 40306642 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Ramón Lindauer, Prof. dr.

  Amsterdam UMC, location AMC/Levvel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Myrna Westerveld, MSc

CONTACT

+31643300014; m.m.westerveld@amsterdamumc.nl

Malindi van der Mheen, Dr.

CONTACT

+31205663383; m.vandermheen@levvel.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: November 22, 2023
• Study Start: October 5, 2022
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1); NL (2)