First-Line Intervention for PTSD - Intensive Treatment

Официальное название

(Cost)-Effectiveness of Intensive Trauma-Focused Treatment Versus Spaced Trauma-Focused Treatment As First Line Treatment for Post-Traumatic Stress Disorder in Adults with Multiple Trauma Exposure: Randomized Controlled Trial

Обзор

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

Вмешательства

• Поведенческое Intensive Treatment
  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 ses
• Поведенческое Treatment as usual
  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 psychoed

Первичные конечные точки

• Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).]

Вторичные конечные точки (10)

• International Trauma Questionnaire (ITQ) [Срок оценки: At baseline (T0).]
• Moral Injury Outcome Scale (MIOS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: At baseline (T0), and at 6 months (T3)]
• Dissociative Symptoms Assessment (DSS-4) [Срок оценки: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).]
• Crisis Support Scale (CSS) [Срок оценки: At baseline (T0), after 6 months (T3)]
• Verbal Learning and Memory Test (VLGT) [Срок оценки: At baseline (T0), after weekly treatment (T2, 17 weeks)]
• Harms [Срок оценки: After intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).]
• Treatment satisfaction [Срок оценки: at 7 weeks (T1) and 17 weeks (T2)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 4 центра

• ARQ IVP — Diemen
• Psychotraumacentrum Haarlem — Haarlem
• Psy-Zo! — Groningen
• ARQ Centrum'45 — Oegstgeest

Публикации

• 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):e PMID 40409963

Идентификаторы

NCT: NCT06700590 · NL86057.018.24 · 10390092110006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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