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Examining the Efficacy of Short-Term Intensive PTSD Treatment on Psychological and Cognitive Impairment Symptoms

25 giugno 2026 aggiornato da: Jaryd Hiser, Ohio State University
Our long-term goal is to provide rapid and sustained reductions of trauma and cognitive-related symptoms among Special Operations personnel with PTSD or subthreshold PTSD. The primary objective of this project is to examine the effectiveness of massed PTSD treatment (i.e., CPT and EMDR) in "real-world" military settings. CPT and EMDR are both empirically supported psychotherapies for PTSD. To accomplish this objective, we will enroll military personnel meeting diagnostic criteria for PTSD or subthreshold PTSD (i.e., meeting threshold levels for 3 of 4 symptom criteria).

Panoramica dello studio

Descrizione dettagliata

Posttraumatic stress disorder (PTSD) is considered one of the "signature injuries" of military operations and is the most frequently diagnosed mental health condition among active-duty military personnel. PTSD is associated with a host of psychological problems (i.e., intrusions, avoidance, negative alterations in cognition/mood, and hyperarousal) and negative outcomes (i.e., occupational and marital dissatisfaction, violence, alcohol and substance abuse, and suicide).1-3 PTSD has also been correlated with poorer cognitive performance across various domains including attention, working memory, processing speed, and executive functioning.4,5 These psychological problems and cognitive impairments significantly impact military personnel's deployment readiness and overall quality of life.

Numerous randomized clinical trials support the efficacy of trauma-focused treatments like cognitive processing therapy (CPT) with multiple populations including active-duty military personnel.6-8 For this reason, CPT is one of three individual manualized trauma-focused psychotherapies that is strongly recommended for the treatment of PTSD by the VA/DOD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Disorder.9 Recent advances in PTSD treatment have shown that the effects of CPT on PTSD symptom reduction and remission are retained when the treatment is delivered in a "massed" format, which entails daily therapy sessions during a 2-3 week window instead of the traditional schedule of one session per week for multiple months.16,23 Massed CPT therefore achieves similar reductions in PTSD symptoms within a much shorter timeframe. Our team has shown, for instance, that over 70% of military personnel and veterans who received CPT in this format no longer met criteria for a PTSD diagnosis at treatment end.10,11 As compared to conventional therapy delivered weekly, massed trauma therapy has higher treatment retention and treatment completion.12 Massed models are also believed to reduce distraction, avoidance, and de-motivation that typically occurs between weekly sessions.13 Meeting with a therapist daily may also increase commitment to therapy due to a greater sense of support.14 Therefore, this strategy would allow increased access to therapy due to higher patient throughput, while providing patients with rapid and sustained symptom reduction, through improved treatment engagement and improved long-term outcomes.

Despite massed CPT's considerable promise, the effectiveness of this delivery model in real-world military settings remains poorly understood because previous research has only been conducted in highly controlled settings using specially trained research therapists who are closely monitored for protocol fidelity and reduced caseloads. The effectiveness of massed CPT when implemented in real-world military settings when delivered by military behavioral health professionals working in busy clinics with high caseloads, multiple competing work demands, and limited time to pursue case consultation and clinical supervision remains unknown, limiting our understanding of how previous research findings will translate to practice settings within a busy military operational environment. These possible barriers to effective implementation are magnified in Special Operations Forces (SOF) units, which typically have a greater number of deployments and often experience more intense combat than conventional forces-two factors associated with higher prevalence of PTSD.15,16 This is especially true for active-duty military personnel, who show attenuated treatment response as compared to civilians.17,18 Recent research has suggested that over 50% of service members retain their PTSD diagnosis after completing weekly CPT.7 PTSD symptom persistence may be explained by insufficient engagement of key causal factors: first, CPT may not induce enough change in relevant causal factors for recovery to occur, implicating the need for higher "doses" of therapy; second, CPT may induce change in only some, but not enough, causal factors, implicating the need for multiple (or different) treatments that target a broader range of causal factors. Supporting the first possibility is research showing that extending the length of CPT by adding more sessions can improve overall rates of recovery.19,20 In an earlier clinical trial of weekly CPT, for instance, 38.7% of active-duty military personnel who completed CPT scheduled twice weekly achieved good end-state by the twelfth and final session and another 20% reached good end-state following additional CPT sessions.19 Critically, 41.3% of CPT completers did not reach good end-state despite receiving 24 sessions of CPT (double CPT's typical "dose"), lending some support for the second possibility: CPT induces change in some, but not enough, causal factors. For this latter subgroup of patients, switching to a different trauma therapy that targets different causal factors may be indicated. Treatment switching is a common strategy in routine clinical practice when patients do not respond to an initial first line treatment. To our knowledge, the effectiveness of switching from one trauma therapy to another has never been investigated. As a result, there are currently no evidence-based decision rules to guide clinician and patient choice regarding "next steps" when patients do not benefit from CPT or any other trauma-focused therapy. This study will therefore be the first to investigate a critical question commonly asked by clinicians and patients: if a patient has not fully recovered from PTSD by the end of a first-line treatment like CPT, should the clinician continue CPT or should they instead switch to a different treatment modality? PTSD is often examined through a psychological lens, however due to the complex relationship between emotional and cognitive processes, there is an increased interest in examining the unique role that cognitive impairment plays in the development and maintenance of PTSD symptoms.22 Due to the frequency of poor PTSD treatment response, active military personnel frequently experience lingering cognitive impairments that may be due to PTSD. These cognitive impairments in turn often hinder recovery from PTSD by negatively affecting treatment response. The most robust findings suggest cognitive impairments in the domains of learning, executive functioning, processing speed, attention, and working memory in individuals with PTSD.4,5 Previous research suggests that cognitive impairments in individuals with PTSD can improve4, however data is limited, especially in active-duty military personnel.

Treatments that provide rapid and sustained reduction from psychological symptoms and cognitive impairments are direly needed, especially in specialized military populations and in "real-world" military settings. Pilot data collected by our team indicate that, as compared to usual care PTSD treatment, massed CPT treatment accelerates reductions in PTSD symptoms among military personnel and veterans. Other previous research suggests adaptive designs utilizing variable-length treatments may also improve treatment efficacy.19 This study will build on these promising findings by utilizing an innovative two-stage clinical trial design evaluating variable-length massed (i.e. daily) PTSD treatment administered under routine operational conditions. Military personnel who do not respond adequately to massed CPT treatment will be randomized to receive additional CPT or EMDR sessions. This design allows us to causally examine the efficacy of increasing treatment dose versus cross-treatment factors that target a broader range of mechanisms.

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • North Carolina
      • Fayetteville, North Carolina, Stati Uniti, 28310
        • Reclutamento
        • Fort Bragg
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

-Treatment-seeking military personnel (i.e., any assigned or aligned JSOC personnel) who meet diagnostic criteria for PTSD or subthreshold PTSD (i.e., meeting diagnostic threshold for 3 of 4 symptom criteria who are (1) 18 years of age or older; (2) current diagnosis of PTSD or subthreshold PTSD (i.e. meeting diagnostic criteria for 3 of 4 symptom criteria, assessed using the DIAMOND); (3) current military personnel; (4) ability to speak and understand the English language; and (5) ability to complete the informed consent process

Exclusion Criteria:

  • (1) substance use disorder requiring medical management; (2) imminent suicide risk warranting inpatient hospitalization or suicide-focused treatment; and (3) impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 10 Sessions
If participants reach good end-state functioning by the end of massed CPT (i.e., session 10), treatment will be discontinued.
CPT is an empirically supported psychotherapy for PTSD that focuses on why patients believe the traumatic event occurred, how that event affected their beliefs about self and others, and how to evaluate their beliefs. Patients learn to label events, thoughts, and subsequent emotions while the therapist helps them examine the facts Session Focus and context of the trauma through Socratic questioning. Using progressive worksheets, patients are taught to examine their own thoughts and emotions and develop new, more balanced thinking about traumatic events. CPT's safety and efficacy is well-established; over 80% of patients receiving the treatment benefit and > 50% reductions in PTSD symptoms are typical.
Altri nomi:
  • CPT
Sperimentale: Additional Sessions
If participants do not reach good end-state functioning, they will proceed to Stage 2. In the second stage of treatment, participants will receive up to five additional therapy sessions. Participants will be randomized to receive either 5 more sessions of CPT, or 5 sessions of EMDR.
CPT is an empirically supported psychotherapy for PTSD that focuses on why patients believe the traumatic event occurred, how that event affected their beliefs about self and others, and how to evaluate their beliefs. Patients learn to label events, thoughts, and subsequent emotions while the therapist helps them examine the facts Session Focus and context of the trauma through Socratic questioning. Using progressive worksheets, patients are taught to examine their own thoughts and emotions and develop new, more balanced thinking about traumatic events. CPT's safety and efficacy is well-established; over 80% of patients receiving the treatment benefit and > 50% reductions in PTSD symptoms are typical.
Altri nomi:
  • CPT
EMDR is another empirically supported trauma-focused psychotherapy that is strongly recommended for the treatment of PTSD by the VA/DOD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Disorder (VA/DOD, 2023). Results of multiple clinical trials indicate EMDR's effectiveness for reducing PTSD symptoms is comparable to CPT's. EMDR directs patients to think about different aspects of an emotionally upsetting memory in mind while simultaneously focusing on an external stimulus. The most common external stimulus is therapist-directed lateral eye movements (e.g., tracking the movement of a therapist's finger back and forth with only the eyes) but other stimuli (e.g., hand-tapping, audio stimulation) can also be used. Half of participants who do not reach good end-state by session 10 will be randomly assigned to receive up to 5 sessions of EMDR during Stage 2.
Altri nomi:
  • EMDR

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Good End-State Functioning
Lasso di tempo: From enrollment to the end of study participation 12 months after enrollment
Good end-state is defined as (a) a score on the PCL-5 ≤ 19 and (b) mutual agreement by the patient and therapist that the patient has achieved the therapy's goals. The PCL-5 is a validated self-report scale that assesses the severity of DSM-5-defined PTSD symptoms within the past week. 28 Items are summed so that higher scores reflect greater symptom severity. Previous research shows that over 94% of military personnel with good end-state following trauma-focused therapy had clinically meaningful improvement in PTSD symptoms using the Reliable Change Index and 79-100% no longer meet DSM-5 criteria for a diagnosis of PTSD.
From enrollment to the end of study participation 12 months after enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PTSD Symptom Severity
Lasso di tempo: From Enrollment to end of study participation 12 months after enrollment
feedback system during treatment.
From Enrollment to end of study participation 12 months after enrollment
Cognitive Performance
Lasso di tempo: From Enrollment to the end of study participation 12 months after enrollment
Cognitive performance will be assessed using the DANA,24 a self-administered mobile phone-based application designed to rapidly assess multiple dimensions of neurocognitive performance in as little as 15 minutes. The DANA was selected as our secondary outcome measure because it has been validated as a tool for diagnosing traumatic brain injury (TBI) among military personnel, can be self-administered by participants on their smart phones, and will be soon used by JSOC cognitive professionals.
From Enrollment to the end of study participation 12 months after enrollment
Demographics
Lasso di tempo: Single time point at enrollment
A standardized demographics form will assess demographic variables including sex, gender, age, and race.
Single time point at enrollment
military service demographics
Lasso di tempo: A single time point at enrollment
A military service demographics form based on the Million Veterans Program survey will be used to assess military-specific variables (e.g., rank, Service Branch).
A single time point at enrollment
Trauma exposure
Lasso di tempo: A single time point at enrollment
Trauma exposure will be assessed using the Life Events Checklist for DSM-5.
A single time point at enrollment
TBI
Lasso di tempo: A single time point at enrollment
History of TBI will be assessed using The Ohio State University Traumatic Brain Injury Identification Method.
A single time point at enrollment
Alcohol use
Lasso di tempo: From enrollment to the end of study participation 12 months after enrollment
Alcohol-related problems will be assessed using the Alcohol Use Disorders Identification Test.
From enrollment to the end of study participation 12 months after enrollment
Sleep Quality
Lasso di tempo: From enrollment to the end of study participation 12 months after enrollment.
Sleep quality will be assessed using the Insomnia Severity Index (ISI).
From enrollment to the end of study participation 12 months after enrollment.
Depression symptoms
Lasso di tempo: From enrollment to the end of study participation 12 months following enrollment
Depression symptoms will be assessed using the Patient Health Questionnaire.
From enrollment to the end of study participation 12 months following enrollment
Suicide risk
Lasso di tempo: From enrollment to the end of study participation 12 months following enrollment
Suicide risk will be measured with the Brief Suicide Cognitions Scale.
From enrollment to the end of study participation 12 months following enrollment
Trauma-related beliefs
Lasso di tempo: From enrollment to the end of study participation 12 months following enrollment
Trauma-related beliefs will be assessed using the shortened version of the Posttraumatic Cognitions Inventory.
From enrollment to the end of study participation 12 months following enrollment
Treatment satisfaction
Lasso di tempo: One time point 1 month after finishing treatment
Treatment satisfaction will be assessed using the Satisfaction with Therapy and Therapist Scale- Revised
One time point 1 month after finishing treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2026

Completamento primario (Stimato)

1 agosto 2028

Completamento dello studio (Stimato)

1 agosto 2028

Date di iscrizione allo studio

Primo inviato

22 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data available by request

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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