Examining Changes in Microbiota Over the Course of PTSD Treatment
Condition: Posttraumatic Stress Disorder; Depression
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The overall goals of this project are to evaluate the use of 5-day intensively-delivered
      Cognitive Processing Therapy to treat PTSD and to determine the associations between the
      microbiome, salivary cytokines, and the presence of and recovery from PTSD. Specifically,
      this study is designed to 1) determine whether individual Cognitive Processing Therapy (CPT)
      delivered twice per day over 5 consecutive days (CPT-5) is tolerable, acceptable, and
      effective in reducing PTSD symptoms, 2) determine the microbial signatures associated with
      PTSD, 3) evaluate whether the abundance and composition of microbiota and salivary cytokine
      levels change over the course of PTSD treatment, and 4) examine whether changes in microbial
      signatures are associated with changes in cytokine levels.
    

Detailed description: 
      This project will evaluate the use of 5-day intensively-delivered Cognitive Processing
      Therapy to treat PTSD and will aim to determine the associations between the microbiome,
      salivary cytokines, and the presence of and recovery from PTSD. A total of 24 participants
      who have experienced a criterion A trauma will be recruited. An intake assessment will be
      used to confirm the fit for the proposed project. Clinical interviewers with a minimum of a
      Master's degree in Psychology who are not providing the treatment will administer structured
      diagnostic interviews (CAPS and DIAMOND). If an individual meets criteria for a PTSD
      diagnosis based on the CAPS they will be eligible for this treatment study.

      Study staff will administer brief computerized assessments (e.g. Stroop task), a full
      self-report assessment battery, and two internet-based dietary assessments to all
      participants. Study staff will also collect fecal- and oral-derived microbiota and salivary
      cytokine samples from individuals who opt in to this aspect of the study.

      Study Treatment - Intensive Week-Long Cognitive Processing Therapy (CPT):

      The individuals in this study will undergo a course of 1-week-long Cognitive Processing
      Therapy (CPT-5). CPT-5 will be delivered twice per day over the course of five business days.
      Each 50 minute session will closely follow the CPT protocol and will be conducted by either
      Dr. Held, other doctoral-level psychologists, postdoctoral fellows, or other Master's level
      (or higher) clinicians who have received the official two-day CPT training and who are not
      involved in study assessments. CPT worksheets and homework assignments may be collected and
      copied for research purposes. Changes in PTSD severity and other relevant symptoms will be
      assessed before, during, and after the course of CPT using well-validated
      clinician-administered, self-report, and computerized assessments. Fecal- and oral-derived
      microbiota as well as salivary cytokines will also be assessed at various pre-treatment,
      post-treatment, and follow-up time points to determine whether the microbiome and cytokine
      levels change over the course of CPT. Participants in this study will have the option to opt
      out of providing these biological samples and still receive CPT-5.

      Semi-Structured Interview:

      Regardless of whether they completed the course of CPT, participants in the study may be
      asked to participate in one 20-40 minute semi-structured interview. The interviewer, who is a
      member of the research team and not the respective participant's study therapist, will ask
      general questions about the participant's experiences of CPT-5 and gather information about
      the participant's perceptions of the tolerability, acceptability, and feasibility of the
      intervention.
    

Intervention name(s): Cognitive Processing Therapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive Processing Therapy is an evidence-based treatment for PTSD that will be delivered intensively twice per day over the course of five days.
Intervention model: Single Group Assignment
Intervention model description: All participants who are eligible for this study will receive a 5 day PTSD treatment.
Masking: None (Open Label)
Primary purpose: Treatment