Trial Outcomes & Findings for Brief Restructuring Intervention Following Trauma Exposure (NCT 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

57 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-02-26

Participant Flow

Participant milestones

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

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=5 Participants	22.1 years STANDARD_DEVIATION 3.4 • n=7 Participants	21.6 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
PTSD Symptom Severity	32.4 score on a scale STANDARD_DEVIATION 8.4 • n=5 Participants	33.2 score on a scale STANDARD_DEVIATION 8.4 • n=7 Participants	32.8 score on a scale STANDARD_DEVIATION 8.3 • n=5 Participants
Timeline Followback Heavy Episodic Drinking Episodes	5.4 episodes STANDARD_DEVIATION 4.4 • n=5 Participants	5.8 episodes STANDARD_DEVIATION 3.5 • n=7 Participants	5.6 episodes STANDARD_DEVIATION 3.9 • n=5 Participants
Alcohol use negative consequences	17.7 score on a scale STANDARD_DEVIATION 24.3 • n=5 Participants	19.8 score on a scale STANDARD_DEVIATION 15.3 • n=7 Participants	18.74 score on a scale STANDARD_DEVIATION 20.1 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Analyzed data from all participants assigned to each condition regardless of completion or missing data (intent to treat).

Outcome measures

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 weeks

Population: 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

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 weeks

Population: 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

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Assessment Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michele Bedard-Gilligan

University of Washington

Phone: 206-616-4215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place