Trial Outcomes & Findings for Evaluation of Web-Based CBT for Women Veterans With PTSD (NCT NCT02917447)

Last Updated: 2020-05-11

Results Overview

The PTSD Symptom-Checklist -Version 5 (PCL-5) is a 20-item, self-report instrument that assesses the presence and severity of DSM-V PTSD symptoms in the last month. It was summed for a total severity score ranging from 0-80, with higher scores representing greater symptom severity. Changes from baseline at three separate times post-baseline are reported for each treatment group. These calculations are based on marginal means estimated from a linear mixed model analysis with PCL as the dependent variable; rural status, MST history, study assessment, treatment group, and study assessment by treatment group interaction as the independent fixed effects; and study participant as a random effect.

Recruitment status

COMPLETED

Study phase

Target enrollment

102 participants

Primary outcome timeframe

Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment

Results posted on

2020-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	DESTRESS-WV Tailored online intervention for PTSD for women Veterans with coach support. DESTRESS-WV: This is an online intervention for PTSD tailored for women Veterans with weekly, 15-minute coach calls. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives. Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress mana	Phone Monitoring Weekly check-in calls from a study coach. Phone Monitoring: A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided.
Overall Study STARTED	51	51
Overall Study COMPLETED	44	48
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Web-Based CBT for Women Veterans With PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DESTRESS-WV n=51 Participants Tailored online intervention for PTSD for women Veterans with coach support. DESTRESS-WV: This is an online intervention for PTSD tailored for women Veterans with weekly, 15-minute coach calls. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives. Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress mana	Phone Monitoring n=51 Participants Weekly check-in calls from a study coach. Phone Monitoring: A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided.	Total n=102 Participants Total of all reporting groups
Age, Continuous	49.9 years STANDARD_DEVIATION 11.3 • n=5 Participants	48.9 years STANDARD_DEVIATION 12.2 • n=7 Participants	49.4 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	51 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants	42 Participants n=7 Participants	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
PTSD Symptom-Checklist -Version 5 (PCL-5)	45.8 units on a scale STANDARD_DEVIATION 10.6 • n=5 Participants	45.0 units on a scale STANDARD_DEVIATION 11.7 • n=7 Participants	45.4 units on a scale STANDARD_DEVIATION 11.1 • n=5 Participants
Patient Health Questionnaire (PHQ)-8	13.6 units on a scale STANDARD_DEVIATION 4.9 • n=5 Participants	13.2 units on a scale STANDARD_DEVIATION 5.5 • n=7 Participants	13.4 units on a scale STANDARD_DEVIATION 5.2 • n=5 Participants
The Quality of Life (QoL) Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)	44.9 units on a scale STANDARD_DEVIATION 15.5 • n=5 Participants	45.5 units on a scale STANDARD_DEVIATION 12.2 • n=7 Participants	45.2 units on a scale STANDARD_DEVIATION 13.9 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment

Population: Intent to treat population (all participants assigned to DESTRESS-WV or Phone Monitoring). Linear mixed effects regressions of PCL on categorical follow-up time, adjusted for rural/urban status and MST.

Outcome measures

Outcome measures
Measure	DESTRESS-WV n=51 Participants Tailored online intervention for PTSD for women Veterans with coach support. DESTRESS-WV: This is an online intervention for PTSD tailored for women Veterans with weekly, 15-minute coach calls. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives. Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress mana	Phone Monitoring n=51 Participants Weekly check-in calls from a study coach. Phone Monitoring: A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided.
Change in PTSD Checklist (PCL-5) Post - Baseline	-13.1 units on a scale Standard Error 2.1	-8.9 units on a scale Standard Error 2.0
Change in PTSD Checklist (PCL-5) 3-month - Baseline	-13.8 units on a scale Standard Error 2.1	-7.5 units on a scale Standard Error 2.0
Change in PTSD Checklist (PCL-5) 6-month - Baseline	-11.4 units on a scale Standard Error 2.1	-8.9 units on a scale Standard Error 2.0

SECONDARY outcome

Timeframe: Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment

Population: Intent to treat population (enrolled in DESTRESS-WV or Phone Monitoring).

The Patient Health Questionnaire-8 (PHQ-8) is a brief self-report assessment of common mental disorders and was used to assess symptoms of depression. The eight items specifically correspond to symptom-based diagnostic criteria in DSM-IV and are summed for a range from 0-24, with a score of 10 or greater indicating major depression. Changes from baseline at three separate times post-baseline are reported for each treatment group. These calculations are based on marginal means estimated from a linear mixed model analysis with PHQ-8 as the dependent variable; rural status, MST history, study assessment, treatment group, and study assessment by treatment group interaction as the independent fixed effects; and study participant as a random effect.

Outcome measures

Outcome measures
Measure	DESTRESS-WV n=51 Participants Tailored online intervention for PTSD for women Veterans with coach support. DESTRESS-WV: This is an online intervention for PTSD tailored for women Veterans with weekly, 15-minute coach calls. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives. Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress mana	Phone Monitoring n=51 Participants Weekly check-in calls from a study coach. Phone Monitoring: A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided.
Change in Patient Health Questionnaire-8 (PHQ-8) Post - Baseline	-3.8 units on a scale Standard Error 0.8	-2.6 units on a scale Standard Error 0.7
Change in Patient Health Questionnaire-8 (PHQ-8) 3 month - Baseline	-3.5 units on a scale Standard Error 0.8	-0.6 units on a scale Standard Error 0.7
Change in Patient Health Questionnaire-8 (PHQ-8) 6 month - Baseline	-2.3 units on a scale Standard Error 0.8	-1.2 units on a scale Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment

Population: Intent to treat population (all participants enrolled in DESTRESS-WV or Phone Monitoring).

The Quality of Life (QoL) Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) was used to assess quality of life. It consists of 16 items that are summed and transformed to a scale ranging from 0-100, with higher scores indicating greater quality of life. Changes from baseline at three separate times post-baseline are reported for each treatment group. These calculations are based on marginal means estimated from a linear mixed model analysis with QoL as the dependent variable; rural status, MST history, study assessment, treatment group, and study assessment by treatment group interaction as the independent fixed effects; and study participant as a random effect.

Outcome measures

Outcome measures
Measure	DESTRESS-WV n=51 Participants Tailored online intervention for PTSD for women Veterans with coach support. DESTRESS-WV: This is an online intervention for PTSD tailored for women Veterans with weekly, 15-minute coach calls. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives. Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress mana	Phone Monitoring n=51 Participants Weekly check-in calls from a study coach. Phone Monitoring: A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided.
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form 3 month - Baseline	4.3 units on a scale Standard Error 2.2	4.8 units on a scale Standard Error 2.1
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form 6 month - Baseline	3.0 units on a scale Standard Error 2.2	3.8 units on a scale Standard Error 2.1
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Post - Baseline	9.1 units on a scale Standard Error 2.2	7.9 units on a scale Standard Error 2.1

Adverse Events

DESTRESS-WV

Serious events: 7 serious events

Other events: 14 other events

Deaths: 0 deaths

Phone Monitoring

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DESTRESS-WV n=51 participants at risk Tailored online intervention for PTSD for women Veterans with coach support. DESTRESS-WV: This is an online intervention for PTSD tailored for women Veterans with weekly, 15-minute coach calls. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives. Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress mana	Phone Monitoring n=51 participants at risk Weekly check-in calls from a study coach. Phone Monitoring: A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided.
General disorders Hospitalizations	3.9% 2/51 • Number of events 3 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	3.9% 2/51 • Number of events 3 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.
Gastrointestinal disorders Hospitalizations	3.9% 2/51 • Number of events 2 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	0.00% 0/51 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.
Cardiac disorders Hospitalizations	2.0% 1/51 • Number of events 1 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	0.00% 0/51 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalizations	2.0% 1/51 • Number of events 1 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	0.00% 0/51 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.
Surgical and medical procedures Hospitalizations	2.0% 1/51 • Number of events 1 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	0.00% 0/51 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.
Pregnancy, puerperium and perinatal conditions Hospitalizations	0.00% 0/51 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	3.9% 2/51 • Number of events 2 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.
Psychiatric disorders Hospitalizations	0.00% 0/51 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	2.0% 1/51 • Number of events 1 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.
Musculoskeletal and connective tissue disorders Hospitalizations	0.00% 0/51 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	2.0% 1/51 • Number of events 1 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.

Other adverse events

Other adverse events
Measure	DESTRESS-WV n=51 participants at risk Tailored online intervention for PTSD for women Veterans with coach support. DESTRESS-WV: This is an online intervention for PTSD tailored for women Veterans with weekly, 15-minute coach calls. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives. Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress mana	Phone Monitoring n=51 participants at risk Weekly check-in calls from a study coach. Phone Monitoring: A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided.
Psychiatric disorders Symptom exacerbation	13.7% 7/51 • Number of events 12 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	13.7% 7/51 • Number of events 9 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.
General disorders Emergency Room Visit	7.8% 4/51 • Number of events 4 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	7.8% 4/51 • Number of events 4 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.
Psychiatric disorders Hopelessness	3.9% 2/51 • Number of events 2 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	5.9% 3/51 • Number of events 4 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.
Psychiatric disorders Suicidal ideation	2.0% 1/51 • Number of events 1 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	7.8% 4/51 • Number of events 6 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.
Psychiatric disorders Distress	2.0% 1/51 • Number of events 1 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.	3.9% 2/51 • Number of events 2 • Adverse events were collected up through the 6-month post-treatment assessment. Adverse Events are reported if they occurred after randomization to study condition. Hospitalizations were assessed systematically at all assessments. If the reason for the hospitalization was unknown, it is categorized under "general disorders." Symptom exacerbations were defined as an increase of 7 or more points on a shortened-PCL from baseline, assessed during weekly coaching calls during the treatment phase. Statements of hopelessness, suicidal ideation, and ER visits were not systematically assessed in self-report forms but addressed verbally during calls with study staff.

Additional Information

Keren Lehavot, PhD

VA Puget Sound Health Care System

Phone: 206-277-1511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place