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| ID | Type | Description | Link |
|---|---|---|---|
| 5KL2TR002387-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University of Chicago | OTHER |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive 5-day Cognitive Processing Therapy for PTSD | Experimental | Participants who are eligible for and enrolled in the study will receive a 5-day CPT treatment for PTSD. All participants will be asked to complete clinician-rated and self-report assessments at multiple time points during the study. Participants will also be asked to provide fecal and saliva samples as part of the study, however, they may opt out of biological sample collection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy | Behavioral | Cognitive Processing Therapy is an evidence-based treatment for PTSD that will be delivered intensively twice per day over the course of five days. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | This will be used to assess severity of posttraumatic stress disorder symptoms at intake.The PTSD Checklist for DSM-5 (PCL-5) measures severity of PTSD symptoms. This questionnaire includes 20 items, which each item rated on a scale of 0 (not at all)-4 (extremely). There are four subscales reflecting symptom clusters in the DSM-5: intrusion (five items), avoidance (two items), negative alterations in cognitions and mood (seven items), and alterations in arousal and reactivity (six items). All 20 items are summed to calculate a total score. Scores range from 0-80, with higher scores indicating more severe symptoms. | Baseline |
| Change in PTSD Checklist for DSM-5 (PCL-5) From Baseline | This will be used to assess changes in posttraumatic stress disorder symptom severity from baseline to the time points described below and/or changes between the time points described below. The PTSD Checklist for DSM-5 (PCL-5) measures severity of PTSD symptoms. This questionnaire includes 20 items, which each item rated on a scale of 0 (not at all)-4 (extremely). There are four subscales reflecting symptom clusters in the DSM-5: intrusion (five items), avoidance (two items), negative alterations in cognitions and mood (seven items), and alterations in arousal and reactivity (six items). All 20 items are summed to calculate a total score. Scores range from 0-80, with higher scores indicating more severe symptoms. | 1 week post-treatment, 3 months post treatment |
| Patient Health Questionnaire-9 (PHQ-9) | This will be used to assess severity of depression symptoms at intake. The Patient Health Quetionnaire-9 (PHQ-9) measures severity of depression symptoms. This questionnaire includes 10 items, with each item rated on a scale of 0 (not at all)-3 (nearly every day). The first 9 items are summed to calculate a total score. Scores range from 0-27, with higher scores indicating more severe symptoms. The tenth item (also rated 0-3) is not included in the total score, but indicates how much interference the responder experiences in their day to day life due to symptoms they are experiencing. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic Cognitions Inventory (PTCI) | Will be used to assess intensity of negative posttrauma cognitions at intake. The PTCI score is calculated by summing all items, with scores ranging from 22 to 231. Higher scores indicate more severe negative cognitions. | Baseline |
| Change in Posttraumatic Cognitions Inventory (PTCI) From Baseline |
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Inclusion Criteria:
Individuals are eligible for the study if they:
Exclusion Criteria:
Individuals are excluded from the study if:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive 5-day Cognitive Processing Therapy for PTSD | Participants who are eligible for and enrolled in the study will receive a 5-day CPT treatment for PTSD. All participants will be asked to complete clinician-rated and self-report assessments at multiple time points during the study. Participants will also be asked to provide fecal and saliva samples as part of the study, however, they may opt out of biological sample collection. Cognitive Processing Therapy: Cognitive Processing Therapy is an evidence-based treatment for PTSD that will be delivered intensively twice per day over the course of five days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive 5-day Cognitive Processing Therapy for PTSD | Participants who are eligible for and enrolled in the study will receive a 5-day CPT treatment for PTSD. All participants will be asked to complete clinician-rated and self-report assessments at multiple time points during the study. Participants will also be asked to provide fecal and saliva samples as part of the study, however, they may opt out of biological sample collection. Cognitive Processing Therapy: Cognitive Processing Therapy is an evidence-based treatment for PTSD that will be delivered intensively twice per day over the course of five days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PTSD Checklist for DSM-5 (PCL-5) | This will be used to assess severity of posttraumatic stress disorder symptoms at intake.The PTSD Checklist for DSM-5 (PCL-5) measures severity of PTSD symptoms. This questionnaire includes 20 items, which each item rated on a scale of 0 (not at all)-4 (extremely). There are four subscales reflecting symptom clusters in the DSM-5: intrusion (five items), avoidance (two items), negative alterations in cognitions and mood (seven items), and alterations in arousal and reactivity (six items). All 20 items are summed to calculate a total score. Scores range from 0-80, with higher scores indicating more severe symptoms. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
Data were collected from Baseline to 3 months follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intensive 5-day Cognitive Processing Therapy for PTSD | Participants who are eligible for and enrolled in the study will receive a 5-day CPT treatment for PTSD. All participants will be asked to complete clinician-rated and self-report assessments at multiple time points during the study. Participants will also be asked to provide fecal and saliva samples as part of the study, however, they may opt out of biological sample collection. Cognitive Processing Therapy: Cognitive Processing Therapy is an evidence-based treatment for PTSD that will be delivered intensively twice per day over the course of five days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philip Held | Rush University Medical Center | 312-942-1423 | philip_held@rush.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2020 | Apr 3, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2022 | Apr 3, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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All participants who are eligible for this study will receive a 5 day PTSD treatment.
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| Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline |
This will be used to assess changes in depression symptom severity from baseline to the time points described below and/or changes between the time points described below. This will be used to assess severity of depression symptoms at intake. The Patient Health Quetionnaire-9 (PHQ-9) measures severity of depression symptoms. This questionnaire includes 10 items, with each item rated on a scale of 0 (not at all)-3 (nearly every day). The first 9 items are summed to calculate a total score. Scores range from 0-27, with higher scores indicating more severe symptoms. The tenth item (also rated 0-3) is not included in the total score, but indicates how much interference the responder experiences in their day to day life due to symptoms they are experiencing. |
| 1 week post-treatment, 3 months post-treatment |
| Change in DNA Genotek OMNIgeneGUT for Microbiome Kit (OMR-200) From Baseline | Change in microbial signature (abundance and composition) from colonic fecal sample from baseline to the time points described below and/or changes between the time points described below. | Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment |
| DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501) | Microbial signature (abundance and composition) from oral saliva sample collected at intake. | Baseline |
| Change in DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501) From Baseline | Change in microbial signature (abundance and composition) from oral saliva sample from baseline to the time points described below and/or changes between the time points described below. | Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment |
| Salimetrics Salivary Cytokine Panel | Salivary cytokine levels (TNF-alpha, IL-1beta, IL-6, IL-8) from oral saliva sample collected at intake. | Baseline |
| Change in Salimetrics Salivary Cytokine Panel From Baseline | Change in salivary cytokine levels (TNF-alpha, IL-1beta, IL-6, IL-8) from baseline to the time points described below and/or changes between the time points described below. | Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment |
Will be used to assess changes in intensity of negative posttrauma cognitions from baseline to the time points described below and/or changes between the time points described below. The PTCI score is calculated by summing all items, with scores ranging from 22 to 231. Higher scores indicate more severe negative cognitions. |
| 1 week post-treatment |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Change in PTSD Checklist for DSM-5 (PCL-5) From Baseline | This will be used to assess changes in posttraumatic stress disorder symptom severity from baseline to the time points described below and/or changes between the time points described below. The PTSD Checklist for DSM-5 (PCL-5) measures severity of PTSD symptoms. This questionnaire includes 20 items, which each item rated on a scale of 0 (not at all)-4 (extremely). There are four subscales reflecting symptom clusters in the DSM-5: intrusion (five items), avoidance (two items), negative alterations in cognitions and mood (seven items), and alterations in arousal and reactivity (six items). All 20 items are summed to calculate a total score. Scores range from 0-80, with higher scores indicating more severe symptoms. | Posted | Mean | Standard Deviation | score on a scale | 1 week post-treatment, 3 months post treatment |
|
|
|
| Primary | Patient Health Questionnaire-9 (PHQ-9) | This will be used to assess severity of depression symptoms at intake. The Patient Health Quetionnaire-9 (PHQ-9) measures severity of depression symptoms. This questionnaire includes 10 items, with each item rated on a scale of 0 (not at all)-3 (nearly every day). The first 9 items are summed to calculate a total score. Scores range from 0-27, with higher scores indicating more severe symptoms. The tenth item (also rated 0-3) is not included in the total score, but indicates how much interference the responder experiences in their day to day life due to symptoms they are experiencing. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline | This will be used to assess changes in depression symptom severity from baseline to the time points described below and/or changes between the time points described below. This will be used to assess severity of depression symptoms at intake. The Patient Health Quetionnaire-9 (PHQ-9) measures severity of depression symptoms. This questionnaire includes 10 items, with each item rated on a scale of 0 (not at all)-3 (nearly every day). The first 9 items are summed to calculate a total score. Scores range from 0-27, with higher scores indicating more severe symptoms. The tenth item (also rated 0-3) is not included in the total score, but indicates how much interference the responder experiences in their day to day life due to symptoms they are experiencing. | Posted | Mean | Standard Deviation | score on a scale | 1 week post-treatment, 3 months post-treatment |
|
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| Primary | Change in DNA Genotek OMNIgeneGUT for Microbiome Kit (OMR-200) From Baseline | Change in microbial signature (abundance and composition) from colonic fecal sample from baseline to the time points described below and/or changes between the time points described below. | This part of the study was discontinued as COVID protocols required the study to move to a virtual format where this type of data was unable to be collected. | Posted | Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment |
|
|
| Primary | DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501) | Microbial signature (abundance and composition) from oral saliva sample collected at intake. | This part of the study was discontinued as COVID protocols required the study to move to a virtual format where this type of data was unable to be collected. | Posted | Baseline |
|
|
| Primary | Change in DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501) From Baseline | Change in microbial signature (abundance and composition) from oral saliva sample from baseline to the time points described below and/or changes between the time points described below. | This part of the study was discontinued as COVID protocols required the study to move to a virtual format where this type of data was unable to be collected. | Posted | Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment |
|
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| Primary | Salimetrics Salivary Cytokine Panel | Salivary cytokine levels (TNF-alpha, IL-1beta, IL-6, IL-8) from oral saliva sample collected at intake. | This part of the study was discontinued as COVID protocols required the study to move to a virtual format where this type of data was unable to be collected. | Posted | Baseline |
|
|
| Primary | Change in Salimetrics Salivary Cytokine Panel From Baseline | Change in salivary cytokine levels (TNF-alpha, IL-1beta, IL-6, IL-8) from baseline to the time points described below and/or changes between the time points described below. | This part of the study was discontinued as COVID protocols required the study to move to a virtual format where this type of data was unable to be collected. | Posted | Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment |
|
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| Secondary | Posttraumatic Cognitions Inventory (PTCI) | Will be used to assess intensity of negative posttrauma cognitions at intake. The PTCI score is calculated by summing all items, with scores ranging from 22 to 231. Higher scores indicate more severe negative cognitions. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
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| Secondary | Change in Posttraumatic Cognitions Inventory (PTCI) From Baseline | Will be used to assess changes in intensity of negative posttrauma cognitions from baseline to the time points described below and/or changes between the time points described below. The PTCI score is calculated by summing all items, with scores ranging from 22 to 231. Higher scores indicate more severe negative cognitions. | Posted | Mean | Standard Deviation | score on a scale | 1 week post-treatment |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| D001519 | Behavior |