First-Line Intervention for PTSD - Intensive Treatment

Not Applicable

Recruiting

• Conditions: PTSD - Post Traumatic Stress Disorder

• Registration Number: NCT06700590
• Lead Sponsor: ARQ National Psychotrauma Centre

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-19
• Study Start: 2024-11-21
• Study First Posted: 2024-11-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Primary Completion: 2028-04-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• 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);
• employed (working or on sick leave for less than two years)

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).	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.
Cost-effectiveness (Quality of life)	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 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.
Cost-effectiveness (Mental Health Quality of Life Questionnaire)	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 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).
Cost-effectiveness (Treatment inventory of costs)	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 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.

Secondary Outcome Measures

Name	Time	Method
International Trauma Questionnaire (ITQ)	At baseline (T0).	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.
Moral Injury Outcome Scale (MIOS)	At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).	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.
Hospital Anxiety and Depression Scale (HADS)	At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).	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.
Acceptance and Action Questionnaire (AAQ-II)	At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).	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.
Personality Inventory for DSM-5-Brief Form-Adult (PID-5-BF-NL)	At baseline (T0), and at 6 months (T3)	Maladaptive Personality Traits will be assessed by the Personality Inventory for DSM-5-Brief Form-Adult (PID-5-BF-NL). The PID-5-BF-NL will be employed to assess maladaptive personality traits as defined in the alternative DSM-5 model for personality disorders. This self-rated scale comprises 25 items evaluating five personality trait domains. The reliability and validity of the PID-5-BF-NL have demonstrated adequacy to good.
Dissociative Symptoms Assessment (DSS-4)	At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).	Dissociative Symptoms will be assessed using the Dissociative Symptoms Assessment (DSS-4): The DSS, will be utilized to assess psychoform and somatoform dissociative symptoms experienced in the past week. The scale comprises 21 items and exhibits high internal consistency (Cronbach's alpha = .92) and reliability.
Crisis Support Scale (CSS)	At baseline (T0), after 6 months (T3)	Social Support will be administered by the Crisis Support Scale (CSS) to evaluate social support, assessing total social support and satisfaction with support. The CSS consists of 7 items and has demonstrated both good validity and reliability. The CSS assessments will be conducted at baseline (T0) and 6 months (T3), with a total assessment duration of 10 minutes.
Verbal Learning and Memory Test (VLGT)	At baseline (T0), after weekly treatment (T2, 17 weeks)	The Verbal Learning and Memory Test (VLGT), a Dutch version of the American California Verbal Learning Test by Delis, will be employed to assess verbal memory functions in adults. This test evaluates learning performance, speed of learning and forgetting, encoding modes, memorization, recognition over time, sensitivity to interference, the tendency to confabulate, and persistence. The VLGT is a reliable and valid test.
Harms	After intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).	Harms will be assessed by inquiring, 'Have you experienced any issues since your last visit?' following the recommendation by the STRONG STAR consortium.
Treatment satisfaction	at 7 weeks (T1) and 17 weeks (T2)	Treatment satisfaction will be assessed at 7 weeks (T1) and 17 weeks (T2) for the intensive treatment and treatment as usual, respectively. The Client Satisfaction Questionnaire 8 (CSQ-8) and the Visual Analog Scale will be used. The CSQ-8 is a questionnaire with 8 questions rated on a four-point Likert scale, validated in Dutch samples with high internal consistency and similar psychometric properties to the English version. The Visual Analog Scale with 1 indicating the lowest possible rating and 10 representing the highest possible rating, is utilized for assessing the treatment. Additionally, it includes an inquiry about what modifications or improvements are required to achieve a perfect rating of 10.

Trial Locations

Locations (4)

ARQ IVP; 🇳🇱 Diemen, Noord-Holland, Netherlands

Psychotraumacentrum Haarlem; 🇳🇱 Haarlem, Noord-Holland, Netherlands

ARQ Centrum'45; 🇳🇱 Oegstgeest, Zuid-Holland, Netherlands

Psy-Zo!; 🇳🇱 Groningen, Netherlands