First-Line Intervention for PTSD - Intensive Treatment

NCT06700590 | Recruiting

• 2 other identifiers: NL86057.018.2410390092110006
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 4

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

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

intensive treatment; massed treatment; randomized controlled trial; RCT; first time treatment

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  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 (10)

• International Trauma Questionnaire (ITQ)

  At baseline (T0).

• 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).

• 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).

• 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).

• Personality Inventory for DSM-5-Brief Form-Adult (PID-5-BF-NL)

  At baseline (T0), and at 6 months (T3)

Other Outcomes (5)

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

  At baseline (T0).

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

  At baseline (T0).

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

  At baseline (T0).

Study Arms (2)

massed/intensive treatment

EXPERIMENTAL

Behavioral: Intensive Treatment

spaced/weekly treatment

ACTIVE COMPARATOR

Behavioral: Treatment as usual

Interventions

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.

massed/intensive treatment

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

spaced/weekly treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• ARQ National Psychotrauma Centre: lead
• Rijksuniversiteit Groningen: collaborator
• Psychotraumacentrum Haarlem: collaborator
• ARQ IVP BV: collaborator
• Militaire GGZ: collaborator
• Psy-zo BV: collaborator
• Erasmus University Rotterdam: collaborator

Study Sites (4)

ARQ IVP

Diemen, North Holland, 1112 XE, Netherlands

RECRUITING

Psychotraumacentrum Haarlem

Haarlem, North Holland, 2011 VE, Netherlands

RECRUITING

Psy-Zo!

Groningen, Provincie Groningen, 9747 AN, Netherlands

RECRUITING

ARQ Centrum'45

Oegstgeest, South Holland, 2342 AX, Netherlands

RECRUITING

Related Publications (1)

• Kemmere B, van Pelt YT, Lommen MJJ, Huntjens RJC, Olff M, Mendez MZ, Matthijssen S, Hakkaart-van Roijen L, Nijdam MJ, Heide FJJT. Cost-effectiveness of massed versus spaced trauma-focused treatment as first-line treatment for post-traumatic stress disorder in adults with multiple trauma exposure: protocol for a single-blind non-inferiority randomised controlled trial. BMJ Open. 2025 May 23;15(5):e102530. doi: 10.1136/bmjopen-2025-102530.

  PMID: 40409963 DERIVED

MeSH Terms

Conditions

Combat Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Mirjam Mink-Nijdam, PhD

  ARQ National Psychotrauma Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirjam Mink-Nijdam, PhD

CONTACT

+31(0)20 840 7640; m.mink@centrum45.nl

Bram Kemmere, Msc.

CONTACT

+31(0)20 840 7640; b.kemmere@arq.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For the clinical interviews (CAPS-5, MINI-S, VLGT), the trained assessors will be blind to condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 22, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 6 months after publication, at least until 15 years after completion of the trial.
• Access Criteria: The IPD can be requested with the first authors by other researchers. Requests will be evaluated on a case-by-case basis. The smallest possible dataset will be delivered, ensuring anonymization of data.

Locations

NL (4)