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

Last updated: November 16, 2023
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Post-traumatic Stress Disorders

Panic Disorders

Treatment

Brief Intensive Trauma Treatment

Clinical Study ID

NCT06143982
Effectstudie BITT
  • Ages 12-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of thefollowing criteria:

  • 12-18 years of age;
  • with a history of psychological trauma (conform the Life Events Checklist of theClinician 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, Dand E;
  • or fully meeting criterion A, F, G and at least the B, C, D or E symptomclusters;
  • and written informed consent must be provided by the adolescent and, for adolescentsaged 12-15 years, all legal guardians.

Exclusion

Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded fromparticipation 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 currentprimary-care system.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Brief Intensive Trauma Treatment
Phase:
Study Start date:
October 05, 2022
Estimated Completion Date:
February 01, 2026

Study 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.

Connect with a study center

  • Mental Health Caribbean

    Kralendijk,
    Bonaire, Sint Eustatius and Saba

    Active - Recruiting

  • Amsterdam UMC, location AMC/Levvel

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Active - Recruiting

  • Karakter

    Almelo, Overijsel 7600 AP
    Netherlands

    Active - Recruiting

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