Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07680517
Enrollment
120
Registered
2026-07-02
Start date
2026-04-01
Completion date
2028-08-01
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Performance, PTSD

Keywords

PTSD, CPT, Military

Brief summary

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).

Detailed description

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.

Interventions

BEHAVIORALCognitive Processing Therapy

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.

BEHAVIORALEye-Movement Desensitization and Reprocessing

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.

Sponsors

Ohio State University
Lead SponsorOTHER
Congressionally Directed Medical Research Programs
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study will be utilizing a 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Good End-State FunctioningFrom enrollment to the end of study participation 12 months after enrollmentGood 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.

Secondary

MeasureTime frameDescription
TBIA single time point at enrollmentHistory of TBI will be assessed using The Ohio State University Traumatic Brain Injury Identification Method.
Alcohol useFrom enrollment to the end of study participation 12 months after enrollmentAlcohol-related problems will be assessed using the Alcohol Use Disorders Identification Test.
Sleep QualityFrom enrollment to the end of study participation 12 months after enrollment.Sleep quality will be assessed using the Insomnia Severity Index (ISI).
Depression symptomsFrom enrollment to the end of study participation 12 months following enrollmentDepression symptoms will be assessed using the Patient Health Questionnaire.
Suicide riskFrom enrollment to the end of study participation 12 months following enrollmentSuicide risk will be measured with the Brief Suicide Cognitions Scale.
Trauma-related beliefsFrom enrollment to the end of study participation 12 months following enrollmentTrauma-related beliefs will be assessed using the shortened version of the Posttraumatic Cognitions Inventory.
PTSD Symptom SeverityFrom Enrollment to end of study participation 12 months after enrollmentfeedback system during treatment.
Cognitive PerformanceFrom Enrollment to the end of study participation 12 months after enrollmentCognitive 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.
DemographicsSingle time point at enrollmentA standardized demographics form will assess demographic variables including sex, gender, age, and race.
military service demographicsA single time point at enrollmentA military service demographics form based on the Million Veterans Program survey will be used to assess military-specific variables (e.g., rank, Service Branch).
Treatment satisfactionOne time point 1 month after finishing treatmentTreatment satisfaction will be assessed using the Satisfaction with Therapy and Therapist Scale- Revised
Trauma exposureA single time point at enrollmentTrauma exposure will be assessed using the Life Events Checklist for DSM-5.

Countries

United States

Contacts

CONTACTJaryd Hiser, PhD
Jaryd.Hiser@osumc.edu6146858746

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026