Post-traumatic Stress Disorder
Conditions
Keywords
PTSD, Trauma, Intensive treatment, BITT, Adolescents
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.
Interventions
BEHAVIORALBrief 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).
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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 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. |
| 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 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. |
| 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). |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Age (moderator) | Age is documented at pre-treatment (T0). | Age will be studied as a moderator on the effectiveness of BITT on PTSD. |
| Sex (moderator) | Sex is documented at pre-treatment (T0). | Sex will be studied as a moderator on the effectiveness of BITT on PTSD. |
| Socioeconomic status (SES; moderator) | SES is documented at pre-treatment (T0). | SES will be studied as a moderator on the effectiveness of BITT on PTSD. |
| Type of trauma (moderator) | Type of trauma is measured at pre-treatment (T0). | 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). |
| Number of traumatic events (moderator) | Number of traumatic events is measured at pre-treatment (T0). | 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). |
| Comorbidity (anger symptoms; moderator) | 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 (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). |
| Comorbidity (anxiety symptoms moderator) | 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 (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). |
| Comorbidity (depression symptoms; moderator) | 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. | 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). |
| Parental PTSD (moderator) | 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. | 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). |
| Treatment center (Participating centers: Levvel/Karakter/Mental Health Caribbean; moderator) | Treatment center (Levvel, Karakter, Mental Health Caribbean) is documented at pre-treatment (T0). | Treatment center (Levvel, Karakter, Mental Health Caribbean) will be studied as a moderator on the effectiveness of BITT on PTSD. |
| Residency (urban/rural; moderator) | Residency is documented at pre-treatment (T0). | Residency (urban/rural) will be studied as a moderator on BITT dropout. |
| Ethnicity | Ethnicity is documented at pre-treatment (T0). | Ethnicity will be studied as a moderator on BITT dropout. |
Countries
Bonaire, Saint Eustatius and Saba , Netherlands
Contacts
Primary ContactMyrna Westerveld, MSc
Backup ContactMalindi van der Mheen, Dr.
Outcome results
None listed