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

NCT07680517 | Recruiting

• 1 other identifier: HT9425-25-1-0944
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

PTSD; Cognitive Performance

Keywords

PTSD; CPT; Military

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (12)

• PTSD Symptom Severity

  From Enrollment to end of study participation 12 months after enrollment

• Cognitive Performance

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

• Demographics

  Single time point at enrollment

• military service demographics

  A single time point at enrollment

• Trauma exposure

  A single time point at enrollment

Study Arms (2)

10 Sessions

EXPERIMENTAL

If participants reach good end-state functioning by the end of massed CPT (i.e., session 10), treatment will be discontinued.

Behavioral: Cognitive Processing Therapy

Additional Sessions

EXPERIMENTAL

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.

Behavioral: Cognitive Processing Therapy; Behavioral: Eye-Movement Desensitization and Reprocessing

Interventions

Cognitive Processing Therapy BEHAVIORAL

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.

Also known as: CPT

10 Sessions; Additional Sessions

Eye-Movement Desensitization and Reprocessing BEHAVIORAL

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.

Also known as: EMDR

Additional Sessions

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• (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).

Sponsors & Collaborators

• Ohio State University: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Fort Bragg

Fayetteville, North Carolina, 28310, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole; Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Jaryd Hiser, PhD

CONTACT

6146858746; Jaryd.Hiser@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)