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PTSDNCT07680517

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

A study testing Cognitive Processing Therapy and Eye-Movement Desensitization and Reprocessing in people with PTSD and Cognitive Performance, run by Ohio State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PTSD, Cognitive Performance
What is being tested?
Cognitive Processing Therapy and Eye-Movement Desensitization and Reprocessing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
1 Apr 2026to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -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

Who cannot join

  • (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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jaryd Hiser, PhD contact

6146858746

Jaryd.Hiser@osumc.edu

United States1 site, 1 recruiting
  • Fort Bragg

    Fayetteville, North Carolina, 28310

    Jaryd Hiser, PhD, 6146858746, jaryd.hiser@osumc.edu

    Recruiting

Other trials in United States

About this study

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).

Read the 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.

Being tested
Cognitive Processing Therapy, Eye-Movement Desensitization and Reprocessing
Keywords
PTSD, CPT, Military
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Processing TherapyBehavioural

    Also called CPT

    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.

  • Eye-Movement Desensitization and ReprocessingBehavioural

    Also called EMDR

    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.

Study groups in NCT07680517
Study groupRoleWhat they receive
10 SessionsExperimentalIf participants reach good end-state functioning by the end of massed CPT (i.e., session 10), treatment will be discontinued.
Receives: Behavioral: Cognitive Processing Therapy
Additional SessionsExperimentalIf 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.
Receives: Behavioral: Cognitive Processing Therapy; Behavioral: Eye-Movement Desensitization and Reprocessing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Good End-State Functioning

    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.

    Measured: From enrollment to the end of study participation 12 months after enrollment

Secondary outcomes (12)
  1. PTSD Symptom Severity

    feedback system during treatment.

    Measured: From Enrollment to end of study participation 12 months after enrollment

  2. Cognitive Performance

    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.

    Measured: From Enrollment to the end of study participation 12 months after enrollment

  3. Demographics

    A standardized demographics form will assess demographic variables including sex, gender, age, and race.

    Measured: Single time point at enrollment

  4. military service demographics

    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).

    Measured: A single time point at enrollment

  5. Trauma exposure

    Trauma exposure will be assessed using the Life Events Checklist for DSM-5.

    Measured: A single time point at enrollment

  6. TBI

    History of TBI will be assessed using The Ohio State University Traumatic Brain Injury Identification Method.

    Measured: A single time point at enrollment

  7. Alcohol use

    Alcohol-related problems will be assessed using the Alcohol Use Disorders Identification Test.

    Measured: From enrollment to the end of study participation 12 months after enrollment

  8. Sleep Quality

    Sleep quality will be assessed using the Insomnia Severity Index (ISI).

    Measured: From enrollment to the end of study participation 12 months after enrollment.

  9. Depression symptoms

    Depression symptoms will be assessed using the Patient Health Questionnaire.

    Measured: From enrollment to the end of study participation 12 months following enrollment

  10. Suicide risk

    Suicide risk will be measured with the Brief Suicide Cognitions Scale.

    Measured: From enrollment to the end of study participation 12 months following enrollment

  11. Trauma-related beliefs

    Trauma-related beliefs will be assessed using the shortened version of the Posttraumatic Cognitions Inventory.

    Measured: From enrollment to the end of study participation 12 months following enrollment

  12. Treatment satisfaction

    Treatment satisfaction will be assessed using the Satisfaction with Therapy and Therapist Scale- Revised

    Measured: One time point 1 month after finishing treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study start1 Apr 2026
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
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.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07680517
Sponsor's protocol ID
HT9425-25-1-0944
Other IDs
HT9425-25-1-0944
Status last verified
Jun 2026
First submitted
22 Jun 2026
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data available by request

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Processing Therapy and Eye-Movement Desensitization and Reprocessing in people with PTSD and Cognitive Performance, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jaryd Hiser, PhD (6146858746, Jaryd.Hiser@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Good End-State Functioning (time frame: From enrollment to the end of study participation 12 months after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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