Trial Outcomes & Findings for Brief Restructuring Intervention Following Trauma Exposure (NCT NCT02808468)
NCT ID: NCT02808468
Last Updated: 2025-02-26
Results Overview
The Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) assesses severity of symptoms of posttraumatic stress disorder (PTSD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline and 3 month follow up to assess change in PTSD symptoms. The range for the scale is 0-80 with higher scores representing more severe PTSD symptoms.
COMPLETED
NA
57 participants
12 weeks
2025-02-26
Participant Flow
Participant milestones
| Measure |
Brief Cognitive Intervention
One in person session (90 minutes) of trauma focused cognitive therapy followed by 4 weekly coaching calls (20 minutes each) with the same study therapist
Brief Cognitive Therapy: Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use
|
Assessment Only
Assessment session followed by weekly completion of assessment measures
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
21
|
27
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brief Restructuring Intervention Following Trauma Exposure
Baseline characteristics by cohort
| Measure |
Brief Cognitive Intervention
n=28 Participants
One in person session (90 minutes) of trauma focused cognitive therapy followed by 4 weekly coaching calls (20 minutes each) with the same study therapist
Brief Cognitive Therapy: Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use
|
Assessment Only
n=29 Participants
Assessment session followed by weekly completion of assessment measures
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.1 years
STANDARD_DEVIATION 4 • n=99 Participants
|
22.1 years
STANDARD_DEVIATION 3.4 • n=107 Participants
|
21.6 years
STANDARD_DEVIATION 3.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 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
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
PTSD Symptom Severity
|
32.4 score on a scale
STANDARD_DEVIATION 8.4 • n=99 Participants
|
33.2 score on a scale
STANDARD_DEVIATION 8.4 • n=107 Participants
|
32.8 score on a scale
STANDARD_DEVIATION 8.3 • n=206 Participants
|
|
Timeline Followback Heavy Episodic Drinking Episodes
|
5.4 episodes
STANDARD_DEVIATION 4.4 • n=99 Participants
|
5.8 episodes
STANDARD_DEVIATION 3.5 • n=107 Participants
|
5.6 episodes
STANDARD_DEVIATION 3.9 • n=206 Participants
|
|
Alcohol use negative consequences
|
17.7 score on a scale
STANDARD_DEVIATION 24.3 • n=99 Participants
|
19.8 score on a scale
STANDARD_DEVIATION 15.3 • n=107 Participants
|
18.74 score on a scale
STANDARD_DEVIATION 20.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Analyzed data from all participants assigned to each condition regardless of completion or missing data (intent to treat).
The Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) assesses severity of symptoms of posttraumatic stress disorder (PTSD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline and 3 month follow up to assess change in PTSD symptoms. The range for the scale is 0-80 with higher scores representing more severe PTSD symptoms.
Outcome measures
| Measure |
Brief Cognitive Intervention
n=28 Participants
One in person session (90 minutes) of trauma focused cognitive therapy followed by 4 weekly coaching calls (20 minutes each) with the same study therapist
Brief Cognitive Therapy: Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use
|
Assessment Only
n=29 Participants
Assessment session followed by weekly completion of assessment measures
|
|---|---|---|
|
Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
|
11.4 score on a scale
Standard Deviation 7.0
|
22.1 score on a scale
Standard Deviation 10.4
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Analyzed data from all participants assigned to each condition regardless of completion or missing data (intent to treat).
The Timeline Followback (TLFB) uses a calendar method with cued recall to assess frequency and quantity of alcoholic beverages consumed. Quantity of drinks are reported per day. Episodes of heavy episodic drinking (4+ drinks per occasion) are counted to calculate the number of HED episodes in the past month. The minimum score possible is 0 for number of HED episodes in the past month and the maximum is 30 (count of days in past 30 days in which HED occurred). Higher numbers indicate more heavy episodic drinking episodes.
Outcome measures
| Measure |
Brief Cognitive Intervention
n=28 Participants
One in person session (90 minutes) of trauma focused cognitive therapy followed by 4 weekly coaching calls (20 minutes each) with the same study therapist
Brief Cognitive Therapy: Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use
|
Assessment Only
n=29 Participants
Assessment session followed by weekly completion of assessment measures
|
|---|---|---|
|
Timeline Followback Heavy Episodic Drinking Episodes
|
2.2 episodes
Standard Deviation 2.7
|
3.7 episodes
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Analyzed data from all participants assigned to each condition regardless of completion or missing data (intent to treat).
Total score of alcohol related negative consequences as reported on the self-report Drinking Inventory of Consequences (DrInC). The total range of scores is 0-135 and higher scores indicate more negative consequences of alcohol use. It is administered at baseline and 3-month follow-up to assess change in alcohol related consequences.
Outcome measures
| Measure |
Brief Cognitive Intervention
n=28 Participants
One in person session (90 minutes) of trauma focused cognitive therapy followed by 4 weekly coaching calls (20 minutes each) with the same study therapist
Brief Cognitive Therapy: Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use
|
Assessment Only
n=29 Participants
Assessment session followed by weekly completion of assessment measures
|
|---|---|---|
|
Drinking Inventory of Consequences (DrInC)
|
7.4 score on a scale
Standard Deviation 14.0
|
19.8 score on a scale
Standard Deviation 15.3
|
Adverse Events
Brief Cognitive Intervention
Assessment Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place