First-Line Intervention for PTSD - Intensive Treatment

ConditionPTSD - Post Traumatic Stress Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorARQ National Psychotrauma Centre

About this trial

The goal of this clinical trial is to learn if an intensive program can treat post-traumatic stress disorder (PTSD) in adults getting treatment for the first time, and whether it has lower societal costs. The main questions it aims to answer are:

* Does an intensive program reduce PTSD symptoms? * How expensive is it on a societal level? Researchers will compare the intensive program to the standard weekly treatment to see if the intensive program works to treat PTSD.

Participants will:

* Get 5 days of intensive treatment in two weeks (with two preparatory and closing sessions), or weekly sessions * Get questionnaires and interviews 5 times in 9 months

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

PTSD diagnosis according to DSM-5 (CAPS-5);

PTSD diagnosis stemming from 2 or more potentially traumatic events (PTEs)

seeking first-time treatment for PTSD (or less than 8 sessions);

Disqualifiers

Current psychotic disorder, severe alcohol or substance use disorder, high suicidal intent (MINI-S for DSM-5) and a concrete suicide plan, or severe aggressive behavior that poses danger for others

insufficient command of the Dutch language to be able to complete the assessments. This will be determined through clinical judgment at intake.

Trial design

Design model

Parallel

Treatments tested in this trial

Intensive Treatment
Behavioral
Participants engage in two preparatory sessions once weekly, lasting 50 minutes each, which focus on psychoeducation and case conceptualization. The core treatment consists of five days of twice-daily sessions delivered over one or two weeks. The first session of the day consists of prolonged exposure (PE). The second session consists of eye movement desensitization and reprocessing (EMDR). Both treatments are performed in strict adherence to their respective manualized protocol. Two closing sessions focus on lessons learned, integration and a prevention plan. The treatment in total lasts 6 weeks and contains 800 minutes of treatment. To enhance practicality, treatment rotation is allowed and encouraged. Rigorous checks on treatment adhenrence will be implemented.
Treatment as usual
Behavioral
Spaced/weekly treatment consists of a treatment-as-usual condition, increasing the representativeness of the control condition. Treatment duration is 800 minutes, either 13 weeks of 60 minutes (with the last sessions being 80 minutes), or 16 weeks of 50 minutes. All evidence-based treatment modalities of the Dutch guidelines are allowed: PE, EMDR, brief eclectic psychotherapy for PTSD (BEPP), narrative exposure therapy (NET), and imaginary rescripting (ImRs). All have common elements of psychoeducation, imaginal exposure, emotional processing, cognitive restructuring and/or meaning making. Treatment adherence will be monitored throughout the intervention. Therapist rotation is not performed

Treatment groups

186 Participants

are divided into 2 treatment groups

Group A: massed/intensive treatmentExperimental treatment 1 intervention

Group B: spaced/weekly treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

The primary outcome, severity of Post-Traumatic Stress Disorder (PTSD) is assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). CAPS-5 is a comprehensive 20-item clinical interview that assesses both the DSM-5 PTSD diagnostic criteria and the severity of PTSD symptoms. Scores range from 0 to 80, with higher scores denoting greater symptom severity. The CAPS-5 showed high internal consistency and interrater reliability, good test-retest reliability, and good validity. All the assessors are or will be trained to administer the Dutch versions of the CAPS-5. It requires a total of 225 minutes to complete at all measurement points.

Time frame

At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).

Cost-effectiveness (Quality of life)

Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. Quality of life will be assessed using the Euro Quality of Life 5 Dimensions (EQ-5D-5L) scale. This scale comprises 14 items categorized into various aspects of health status, rated on a three-point scale.

Time frame

At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).

Cost-effectiveness (Mental Health Quality of Life Questionnaire)

Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. The Mental Health Quality of Life Questionnaire (MHQoL) will be utilized to assess the quality of life among individuals with mental health issues. The MHQoL comprises a descriptive system (the MHQoL-7D) and a visual analog scale (MHQoL-VAS).

Time frame

At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).

Cost-effectiveness (Treatment inventory of costs)

Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. The Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P) will be utilized to map the costs arising from psychosocial problems in adults. It consists of three components: general questions, questions regarding medical care utilization, and questions related to work.

Time frame

At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).

Secondary outcomes

International Trauma Questionnaire (ITQ)

The International Trauma Questionnaire (ITQ; Dutch translation) will be used to address the core features of the diagnosis of Post Traumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD) according to the ICD-11 as main study parameter. Several studies have indicated that the preliminary version of the ITQ is a reliable and valid measure of PTSD symptoms. The ITQ assessments will be conducted at all time points, with a total assessment duration of 50 minutes.

Time frame

At baseline (T0).

Moral Injury Outcome Scale (MIOS)

Moral Injury will be assessed by the Moral Injury Outcome Scale (MIOS). This scale comprises 14 items categorized into two subscales: Shame-Related and Trust-Violation Related Outcomes. It is used to determine if respondents experienced a Potentially Morally Injurious Event (PMIE) and assess the impact of these experiences on well-being. The MIOS also addresses PTSD symptoms related to PMIE. The 14-item MIOS demonstrates invariance and reliability across countries and exhibits two factors: Shame-Related and Trust-Violation-Related Outcomes.

Time frame

At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).

Hospital Anxiety and Depression Scale (HADS)

The Hospital Anxiety and Depression Scale (HADS) is employed to measure core symptoms of anxiety and depression, excluding physical symptoms. It consists of separate anxiety and depression scales, each with 7 items. The HADS exhibits good homogeneity and test-retest reliability for the total scale and subscales, and its dimensional structure and reliability are stable across different medical settings and age groups.

Time frame

At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).

Acceptance and Action Questionnaire (AAQ-II)

Experiential Avoidance will be assessed by the Experiential Avoidance Assessment (AAQ-II): In its Dutch-language version, the Acceptance and Action Questionnaire-II will be used to assess experiential avoidance. It consists of 7 statements, with higher scores indicating lower experiential avoidance and greater acceptance of unpleasant inner experiences. The Dutch AAQ-II has demonstrated similar construct validity and reliability to the English version.

Time frame

At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).

Other outcomes

Mini International Neuropsychiatric Interview - Simplified for DSM-5 (MINI-S)

Diagnoses within the DSM-5 will be assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5 (MINI-S; Dutch translation). The MINI-S is a structured diagnostic interview instrument covering the main disorders in DSM-5. The kappa coefficient, sensitivity, and specificity were rated as good to very good for most diagnoses. Inter-rater and test-retest reliability also demonstrated good results.

Time frame

At baseline (T0).

Life Events Checklist for DSM-5 (LEC-5)

The Dutch version of The Life Events Checklist for DSM-5 (LEC-5) will be employed at baseline (T0) to assess the types of events experienced by patients for determining trauma exposure in accordance with the DSM-5 to develop the patient case conceptualization. The inventory comprises 57 items where patients respond with either yes or no to indicate their experiences, the age at which the experiences occurred, and their frequency. Although psychometric data for the LEC-5 is not currently available, it is anticipated to exhibit few psychometric differences from the original version, which demonstrates generally adequate psychometric properties.

Time frame

At baseline (T0).

Adverse Childhood Experience International Questionnaire for adults (ACE-IQ)

The Adverse Childhood Experience International Questionnaire for adults (ACE-IQ; Dutch translation), a ten-item measure, will be used to assess instances of adverse or traumatic experiences encountered by the patient before reaching the age of 18. The ACE-IQ systematically examines the clients exposure to psychological, physical, and sexual abuse during childhood, as well as household dysfunction. The ACE-IQ demonstrates strong reliability and validity.

Time frame

At baseline (T0).

Hair cortisol

Biomarker assessments, i.e. hair cortisol measurement, will be conducted before treatment (T0) with a total assessment duration of 5 minutes. Hair cortisol measurements provide valuable insights into participants' stress levels and physiological responses over time. If the patient objects to sampling the biomarker, this measurement will be dropped, and the patient can participate in the study.

Time frame

At baseline (T0).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ARQ National Psychotrauma Centre

Lead sponsor

Rijksuniversiteit Groningen

Collaborator

Psychotraumacentrum Haarlem

Collaborator

ARQ IVP BV

Collaborator

Militaire GGZ

Collaborator

Psy-zo BV

Collaborator

Erasmus University Rotterdam

Collaborator

Source ClinicalTrials.gov

Apply now