Trial Outcomes & Findings for Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial (NCT NCT03962504)
NCT ID: NCT03962504
Last Updated: 2024-07-18
Results Overview
The CAPS-5 is a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. Psychometric properties indicate high criterion and construct validity and high agreement with a self-report measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to administer. Scores can range from 0-80, with higher scores indicating greater severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
178 participants
Primary outcome timeframe
change score baseline to 20 weeks
Results posted on
2024-07-18
Participant Flow
Participant milestones
| Measure |
Written Exposure Therapy
The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
Prolonged Exposure
Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
90
|
|
Overall Study
COMPLETED
|
77
|
58
|
|
Overall Study
NOT COMPLETED
|
11
|
32
|
Reasons for withdrawal
| Measure |
Written Exposure Therapy
The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
Prolonged Exposure
Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
|---|---|---|
|
Overall Study
Other
|
11
|
32
|
Baseline Characteristics
Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial
Baseline characteristics by cohort
| Measure |
Written Exposure Therapy
n=88 Participants
The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
Prolonged Exposure
n=90 Participants
Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.17 years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
43.79 years
STANDARD_DEVIATION 13.96 • n=7 Participants
|
44.97 years
STANDARD_DEVIATION 13.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
88 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: change score baseline to 20 weeksThe CAPS-5 is a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. Psychometric properties indicate high criterion and construct validity and high agreement with a self-report measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to administer. Scores can range from 0-80, with higher scores indicating greater severity.
Outcome measures
| Measure |
Written Exposure Therapy
n=88 Participants
The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
Prolonged Exposure
n=90 Participants
Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
|---|---|---|
|
Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5)
|
26.17 CAPS-5 total score
Interval 23.88 to 28.46
|
24.78 CAPS-5 total score
Interval 22.29 to 27.27
|
SECONDARY outcome
Timeframe: change score baseline to 20 weeksPopulation: The sample size is substantially less than the number randomized because the self-report measure was mailed to the study team due to COVID-19 pandemic and response rate for self-report measures was much lower than clinician-administered interviews (i.e., CAPS-5). Accordingly, the planned analysis is not conducted as it is underpowered.
The World Health Organization Quality of Life BREF (WHOQOL-BREF; WHO, 1998) instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that is more convenient for use in large research studies or clinical trials. This measure requires 5-10 minutes to complete. Total score 0-100, with higher scores indicate greater quality of life.
Outcome measures
| Measure |
Written Exposure Therapy
n=38 Participants
The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
Prolonged Exposure
n=36 Participants
Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
|---|---|---|
|
World Health Organization Quality of Life BREF
|
3.21 change score; score on a scale
Standard Deviation 0.49
|
4.13 change score; score on a scale
Standard Deviation 1.15
|
Adverse Events
Written Exposure Therapy
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Prolonged Exposure
Serious events: 7 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Written Exposure Therapy
n=88 participants at risk
The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
Prolonged Exposure
n=90 participants at risk
Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
|---|---|---|
|
Surgical and medical procedures
medical hospitalization
|
3.4%
3/88 • Number of events 3 • 30 weeks
|
3.3%
3/90 • Number of events 3 • 30 weeks
|
|
Infections and infestations
medical hospitalization
|
1.1%
1/88 • Number of events 1 • 30 weeks
|
1.1%
1/90 • Number of events 1 • 30 weeks
|
|
Psychiatric disorders
psychiatric hospitalization
|
0.00%
0/88 • 30 weeks
|
3.3%
3/90 • Number of events 3 • 30 weeks
|
Other adverse events
| Measure |
Written Exposure Therapy
n=88 participants at risk
The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
Prolonged Exposure
n=90 participants at risk
Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
|
|---|---|---|
|
Immune system disorders
contracted COVID-19
|
6.8%
6/88 • Number of events 6 • 30 weeks
|
5.6%
5/90 • Number of events 5 • 30 weeks
|
Additional Information
Dr. Denise Sloan
National Center for PTSD at VA Boston Healthcare System
Phone: 857-364-6333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place