Trial Outcomes & Findings for Sequenced Treatment Effectiveness for Posttraumatic Stress (NCT NCT04597190)
NCT ID: NCT04597190
Last Updated: 2025-05-08
Results Overview
Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
700 participants
Primary outcome timeframe
4 months (Hypothesis 1)
Results posted on
2025-05-08
Participant Flow
Participant milestones
| Measure |
SSRI Then Augmentation by WET
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
169
|
179
|
352
|
|
Overall Study
COMPLETED
|
145
|
150
|
295
|
|
Overall Study
NOT COMPLETED
|
24
|
29
|
57
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sequenced Treatment Effectiveness for Posttraumatic Stress
Baseline characteristics by cohort
| Measure |
SSRI Then Augmentation by WET
n=169 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=179 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=352 Participants
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
Total
n=700 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.6 Years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
44.4 Years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
44.8 Years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
45.1 Years
STANDARD_DEVIATION 15.4 • n=4 Participants
|
|
Sex/Gender, Customized
Man
|
98 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
368 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Woman
|
44 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
212 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Transgender Man
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Transgender Women
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Non-binary or gender fluid
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Another identity
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Missing
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
437 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian, Alaskan Native, or other Indigenous group
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Arab or Middle Eastern
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multi-race
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
92 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
369 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Another Identity
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
169 participants
n=5 Participants
|
179 participants
n=7 Participants
|
352 participants
n=5 Participants
|
700 participants
n=4 Participants
|
|
PTSD Check List (PCL-5)
|
53.2 units on a scale (range 0-80)
STANDARD_DEVIATION 11.5 • n=5 Participants
|
52.8 units on a scale (range 0-80)
STANDARD_DEVIATION 10.9 • n=7 Participants
|
52.6 units on a scale (range 0-80)
STANDARD_DEVIATION 11.0 • n=5 Participants
|
52.8 units on a scale (range 0-80)
STANDARD_DEVIATION 11.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: 4 months (Hypothesis 1)Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
Outcome measures
| Measure |
SSRI Then Augmentation by WET
n=145 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=150 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=295 Participants
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
PTSD Symptoms
|
39.3 units on a scale
Standard Deviation 17.8
|
38.6 units on a scale
Standard Deviation 17.0
|
40.5 units on a scale
Standard Deviation 18.4
|
PRIMARY outcome
Timeframe: 8 Months (Hypotheses 2a and 2b)Population: Participants not responding to treatment at 4-months who completed the 8-month survey
Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
Outcome measures
| Measure |
SSRI Then Augmentation by WET
n=52 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=54 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=124 Participants
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
PTSD Symptoms
|
49.3 units on a scale
Standard Deviation 17.0
|
42.1 units on a scale
Standard Deviation 17.2
|
44.5 units on a scale
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: 4 months (Hypothesis 1)SF-12V, Mental Health Component Summary Score (range 0-100, higher scores are better)
Outcome measures
| Measure |
SSRI Then Augmentation by WET
n=145 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=150 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=293 Participants
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score
|
34.7 units on a scale
Standard Deviation 11.6
|
34.1 units on a scale
Standard Deviation 12.2
|
32.9 units on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 8 Months (Hypotheses 2a and 2b)Population: Participants not responding to treatment at 4-months who completed the 8-month survey
SF-12V, Mental Health Component Summary Score (range 0-100, higher scores are better)
Outcome measures
| Measure |
SSRI Then Augmentation by WET
n=52 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=54 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=124 Participants
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score
|
29.4 units on a scale
Standard Deviation 12.3
|
32.0 units on a scale
Standard Deviation 12.8
|
31.7 units on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 4 months (Hypothesis 1)Population: Participants completing the 4-month survey
Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse)
Outcome measures
| Measure |
SSRI Then Augmentation by WET
n=141 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=156 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=314 Participants
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
Depression Symptoms
|
12.6 units on a scale
Standard Deviation 6.0
|
12.3 units on a scale
Standard Deviation 5.9
|
13.3 units on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 8 Months (Hypotheses 2a and 2b)Population: Participants not responding to treatment at 4-months who completed the 8-month survey
Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse)
Outcome measures
| Measure |
SSRI Then Augmentation by WET
n=52 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=54 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=124 Participants
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
Depression Symptoms
|
14.3 units on a scale
Standard Deviation 6.4
|
13.4 units on a scale
Standard Deviation 5.7
|
14.6 units on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 4 months (Hypothesis 1)Population: Participants completing the survey at 4-months
Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse)
Outcome measures
| Measure |
SSRI Then Augmentation by WET
n=144 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=149 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=290 Participants
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
Generalized Anxiety Symptoms
|
10.7 units on a scale
Standard Deviation 5.5
|
10.4 units on a scale
Standard Deviation 5.2
|
11.2 units on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 8 Months (Hypotheses 2a and 2b)Population: Participants not responding to treatment at 4-months who completed the 8-month survey
Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse)
Outcome measures
| Measure |
SSRI Then Augmentation by WET
n=52 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=54 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=121 Participants
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
Generalized Anxiety Symptoms
|
12.5 units on a scale
Standard Deviation 5.5
|
11.8 units on a scale
Standard Deviation 5.7
|
12.9 units on a scale
Standard Deviation 5.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 months (Hypothesis 1)Population: Participants completing the 4-month survey
Self reported severity of specific side-effects
Outcome measures
| Measure |
SSRI Then Augmentation by WET
n=53 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=54 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=126 Participants
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
Number of Severe and Moderate Side Effects
|
2.9 Number of side-effects
Standard Deviation 2.7
|
2.6 Number of side-effects
Standard Deviation 2.5
|
2.9 Number of side-effects
Standard Deviation 2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 Months (Hypotheses 2a and 2b)Population: Participants not responding to treatment at 4-months who completed the 8-month survey
Self reported severity of specific side-effects
Outcome measures
| Measure |
SSRI Then Augmentation by WET
n=53 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=54 Participants
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=126 Participants
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
Number of Severe and Moderate Side Effects
|
3.3 Number of side-effects
Standard Deviation 2.2
|
2.9 Number of side-effects
Standard Deviation 2.6
|
3.2 Number of side-effects
Standard Deviation 2.6
|
Adverse Events
SSRI Then Augmentation by WET
Serious events: 32 serious events
Other events: 34 other events
Deaths: 0 deaths
SSRI Then Switch to SNRI
Serious events: 34 serious events
Other events: 35 other events
Deaths: 0 deaths
WET Then Switch to SSRI
Serious events: 63 serious events
Other events: 60 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SSRI Then Augmentation by WET
n=169 participants at risk
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=179 participants at risk
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=352 participants at risk
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
|
|---|---|---|---|
|
Investigations
Hospitalization
|
0.59%
1/169 • Number of events 1 • 8 months
|
1.7%
3/179 • Number of events 3 • 8 months
|
2.0%
7/352 • Number of events 7 • 8 months
|
|
Investigations
Emergency Department Admission
|
0.00%
0/169 • 8 months
|
0.56%
1/179 • Number of events 1 • 8 months
|
2.6%
9/352 • Number of events 9 • 8 months
|
|
Investigations
Suicide Intent
|
18.3%
31/169 • Number of events 31 • 8 months
|
16.8%
30/179 • Number of events 30 • 8 months
|
13.1%
46/352 • Number of events 46 • 8 months
|
|
Investigations
Other
|
0.00%
0/169 • 8 months
|
0.00%
0/179 • 8 months
|
0.28%
1/352 • Number of events 1 • 8 months
|
Other adverse events
| Measure |
SSRI Then Augmentation by WET
n=169 participants at risk
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
|
SSRI Then Switch to SNRI
n=179 participants at risk
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitor: Prescribers will prescribe venlafaxine.
|
WET Then Switch to SSRI
n=352 participants at risk
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).
Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine.
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|---|---|---|---|
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Investigations
Increase in suicide ideation
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19.5%
33/169 • Number of events 33 • 8 months
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19.6%
35/179 • Number of events 35 • 8 months
|
17.0%
60/352 • Number of events 60 • 8 months
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|
Investigations
Non-suicidal injury
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0.59%
1/169 • Number of events 1 • 8 months
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0.00%
0/179 • 8 months
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0.00%
0/352 • 8 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place