Health TrialsbyHealthPanel

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

ConditionsPTSDCognitive Performance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

(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 design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: 10 SessionsExperimental treatment 1 intervention
Group B: Additional SessionsExperimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

PTSD Symptom Severity

feedback system during treatment.

Time frame
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.

Time frame
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.

Time frame
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).

Time frame
A single time point at enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator

Source ClinicalTrials.gov
Apply now