Trial Outcomes & Findings for Brief Treatment for Posttraumatic Stress Disorder (NCT NCT03033602)
NCT ID: NCT03033602
Last Updated: 2023-05-24
Results Overview
The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
169 participants
Primary outcome timeframe
Change from baseline to 10-, 20-, 30-weeks post first treatment session
Results posted on
2023-05-24
Participant Flow
Participant milestones
| Measure |
Written Exposure Therapy
5 sessions of imaginal exposure therapy.
written exposure therapy: five sessions of writing about traumatic experience.
|
CPT, Cognitive Only
12 sessions of cognitive therapy.
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
84
|
|
Overall Study
COMPLETED
|
65
|
47
|
|
Overall Study
NOT COMPLETED
|
20
|
37
|
Reasons for withdrawal
| Measure |
Written Exposure Therapy
5 sessions of imaginal exposure therapy.
written exposure therapy: five sessions of writing about traumatic experience.
|
CPT, Cognitive Only
12 sessions of cognitive therapy.
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
21
|
|
Overall Study
discontinued for medical reason or decision by study team
|
9
|
16
|
Baseline Characteristics
Brief Treatment for Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Written Exposure Therapy
n=85 Participants
5 sessions of imaginal exposure therapy.
written exposure therapy: five sessions of writing about traumatic experience.
|
CPT, Cognitive Only
n=84 Participants
12 sessions of cognitive therapy.
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
33.98 years
STANDARD_DEVIATION 6.86 • n=99 Participants
|
33.32 years
STANDARD_DEVIATION 8.22 • n=107 Participants
|
33.65 years
STANDARD_DEVIATION 8.43 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
85 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 10-, 20-, 30-weeks post first treatment sessionPopulation: Non-inferiority margin
The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure.
Outcome measures
| Measure |
Written Exposure Therapy
n=85 Participants
5 sessions of imaginal exposure therapy.
written exposure therapy: five sessions of writing about traumatic experience.
|
CPT, Cognitive Only
n=84 Participants
12 sessions of cognitive therapy.
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.
|
|---|---|---|
|
Clinician Administered PTSD Scale, 5 (CAPS-5)
10-week assessment
|
31.55 score on a scale
Standard Error 1.13
|
25.12 score on a scale
Standard Error 1.40
|
|
Clinician Administered PTSD Scale, 5 (CAPS-5)
30 week assessment
|
27.77 score on a scale
Standard Error 1.61
|
24.97 score on a scale
Standard Error 1.68
|
|
Clinician Administered PTSD Scale, 5 (CAPS-5)
20 week assessment
|
29.59 score on a scale
Standard Error 1.45
|
25.41 score on a scale
Standard Error 1.49
|
Adverse Events
Written Exposure Therapy
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
CPT, Cognitive Only
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Written Exposure Therapy
n=85 participants at risk
5 sessions of imaginal exposure therapy.
written exposure therapy: five sessions of writing about traumatic experience.
|
CPT, Cognitive Only
n=84 participants at risk
12 sessions of cognitive therapy.
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.
|
|---|---|---|
|
Psychiatric disorders
psychiatric hospitalization
|
1.2%
1/85 • Number of events 1 • 6 months.
|
1.2%
1/84 • Number of events 1 • 6 months.
|
Other adverse events
| Measure |
Written Exposure Therapy
n=85 participants at risk
5 sessions of imaginal exposure therapy.
written exposure therapy: five sessions of writing about traumatic experience.
|
CPT, Cognitive Only
n=84 participants at risk
12 sessions of cognitive therapy.
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.
|
|---|---|---|
|
Psychiatric disorders
increase in anxiety symptoms
|
7.1%
6/85 • Number of events 6 • 6 months.
|
8.3%
7/84 • Number of events 7 • 6 months.
|
Additional Information
Dr. Denise Sloan, Professor of Psychiatry
VA Boston Healthcare System & Boston University School of Medicine
Phone: 857-364-6333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place