Trial Outcomes & Findings for Examining Changes in Microbiota Over the Course of PTSD Treatment (NCT NCT04109196)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Baseline

Results posted on

2023-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Examining Changes in Microbiota Over the Course of PTSD Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive 5-day Cognitive Processing Therapy for PTSD n=24 Participants 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.
Age, Continuous	34.8 years STANDARD_DEVIATION 121.2 • n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	17 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	24 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Intensive 5-day Cognitive Processing Therapy for PTSD n=24 Participants 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.
PTSD Checklist for DSM-5 (PCL-5)	53.08 score on a scale Standard Deviation 12.81

PRIMARY outcome

Timeframe: 1 week post-treatment, 3 months post treatment

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.

Outcome measures

Outcome measures
Measure	Intensive 5-day Cognitive Processing Therapy for PTSD n=24 Participants 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.
Change in PTSD Checklist for DSM-5 (PCL-5) From Baseline 1-week post-treatment	17.55 score on a scale Standard Deviation 14.11
Change in PTSD Checklist for DSM-5 (PCL-5) From Baseline 3-months post-treatment	19.42 score on a scale Standard Deviation 15.75

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Intensive 5-day Cognitive Processing Therapy for PTSD n=24 Participants 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.
Patient Health Questionnaire-9 (PHQ-9)	15.38 score on a scale Standard Deviation 4.97

PRIMARY outcome

Timeframe: 1 week post-treatment, 3 months post-treatment

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.

Outcome measures

Outcome measures
Measure	Intensive 5-day Cognitive Processing Therapy for PTSD n=24 Participants 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.
Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline 1-week post-treatment	7.73 score on a scale Standard Deviation 5.51
Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline 3-months post-treatment	6.84 score on a scale Standard Deviation 5.47

SECONDARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Intensive 5-day Cognitive Processing Therapy for PTSD n=24 Participants 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.
Posttraumatic Cognitions Inventory (PTCI)	154.08 score on a scale Standard Deviation 36.71

SECONDARY outcome

Timeframe: 1 week 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.

Outcome measures

Outcome measures
Measure	Intensive 5-day Cognitive Processing Therapy for PTSD n=24 Participants 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.
Change in Posttraumatic Cognitions Inventory (PTCI) From Baseline	89.23 score on a scale Standard Deviation 43.09

Adverse Events

Intensive 5-day Cognitive Processing Therapy for PTSD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Philip Held

Rush University Medical Center

Phone: 312-942-1423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place