Posttraumatic Stress DisorderBRITENCT02808468
Brief Restructuring Intervention Following Trauma Exposure
A study testing Brief Cognitive Therapy in people with Posttraumatic Stress Disorder and Alcohol Use Disorders, run by University of Washington at 1 site in United States.
Trial summary
The broad aim of this study is to develop and test a brief intervention that can be implemented in the immediate weeks following sexual assault to decrease likelihood of developing posttraumatic stress disorder (PTSD) or alcohol misuse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Alcohol Use Disorders
- What is being tested?
- Brief Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2015to Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identifies as female
- Age > 18 years
- 2-10 weeks post sexual assault
- PTSD symptoms related to recent sexual assault, specifically defined as a minimum of
- 1 reexperiencing, 1 avoidance, 2 negative alterations in mood/cognition, or 2 hyperarousal symptoms
- Drinking more than 3 drinks on one occasion in the last month and at least two reported negative consequences of alcohol use
Show all 10Show fewer
- Capacity to provide informed consent
- English fluency
- No planned absences that they would be unable to complete 5 weeks of assessments and coaching calls
- Access to a telephone.
Who cannot join
- Acutely suicidal with intent/plan
- Exhibit current psychosis
- Previous non-response to an adequate trial (8 or more sessions) of Cognitive Processing Therapy (CPT)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Brief Early Cognitive Intervention for PTSD and Alcohol Misuse
The broad aim of this study is to develop and test a brief intervention that can be implemented in the immediate weeks following sexual assault to decrease likelihood of developing posttraumatic stress disorder (PTSD) or alcohol misuse. The first phase of the study will enroll 6 women to complete a brief, cognitive therapy protocol and provide feedback on the intervention (open trial). The second phase of the study will recruit 76 women to complete either the intervention (38 women) or assessment only (38 women) to test the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared to natural recovery following assault.
Read the detailed description
Following sexual assault a substantial number of victims will go on to develop posttraumatic stress disorder (PTSD) or alcohol use disorders (AUD), and development of these disorders is costly to both the victim and society as a whole. Intervening early, in the initial weeks following sexual assault, can provide victims with coping strategies that can decrease the likelihood of developing chronic symptoms. Cognitive approaches for treating symptoms of PTSD have strong empirical support with chronic presentation of symptoms. Less is known about effective strategies for intervening acutely following sexual assault. This project is designed to adapt existing empirically supported cognitive treatment principles for both PTSD and AUD symptoms to be delivered acutely (within 10 weeks of assault) in a brief one session format followed by 4 weekly coaching calls. The first 6 participants enrolled will receive the intervention and provide us with feedback on strengths and weaknesses of the protocol to help us improve it (Open Trial). In the next phase, the pilot testing phase, the study will enroll 38 women to complete the one session intervention followed by 4 once per week coaching calls. Participants will then be assessed again for symptoms of PTSD and alcohol use behavior at 3 month follow-up. This brief intervention group will be compared at the 3 month follow-up to a group of 38 women who receive weekly symptom monitoring only. Thus, this research aims to provide information on the efficacy of the intervention compared to the natural recovery process. This research is significant in its potential to use a very brief and easy to access treatment to decrease the development of chronic psychopathology in a high risk group of women.
- Being tested
- Brief Cognitive Therapy
- Keywords
- Sexual assault, Posttraumatic Stress Disorder, Alcohol use, Cognitive therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Cognitive TherapyBehavioural
Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use
| Study group | Role | What they receive |
|---|---|---|
| Brief Cognitive Intervention | Active comparator | 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 Receives: Behavioral: Brief Cognitive Therapy |
| Assessment Only | No intervention | Assessment session followed by weekly completion of assessment measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
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.
Measured: 12 weeks
Timeline Followback Heavy Episodic Drinking Episodes
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.
Measured: 12 weeks
Secondary outcomes (1)
Drinking Inventory of Consequences (DrInC)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start1 Mar 2015
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Michele Bedard-Gilligan, University of Washington
- Investigators
- Michele Bedard-Gilligan, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808468
- Sponsor's protocol ID
- STUDY00003232
- Other IDs
- 1R34AA022966-01A1
- Acronym
- BRITE
- Status last verified
- Feb 2025
- First submitted
- 17 Jun 2016
- Last updated
- 26 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bedard-Gilligan MA, Stappenbeck CA, Ojalehto HJ, Dworkin ER, Cadigan JM, Simpson T, Kaysen DL. A pilot randomized controlled trial of cognitive restructuring for PTSD and alcohol misuse following recent sexual assault: Initial efficacy and feasibility. Behav Res Ther. 2025 Oct;193:104847. doi: 10.1016/j.brat.2025.104847. Epub 2025 Aug 28.
PubMed 40925075O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
PubMed 37795783
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Brief Early Cognitive Intervention for PTSD and Alcohol Misuse
- ClinicalTrials.gov ID
- NCT02808468
- Acronym / sponsor ID
- BRITE / STUDY00003232
- Keywords
- Sexual assault, Posttraumatic Stress Disorder, Alcohol use, Cognitive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Mar 2015
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 26 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The broad aim of this study is to develop and test a brief intervention that can be implemented in the immediate weeks following sexual assault to decrease likelihood of developing posttraumatic stress disorder (PTSD) or alcohol misuse. The first phase of the study will enroll 6 women to complete a brief, cognitive therapy protocol and provide feedback on the intervention (open trial). The second phase of the study will recruit 76 women to complete either the intervention (38 women) or assessment only (38 women) to test the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared to natural recovery following assault.
Detailed description
Following sexual assault a substantial number of victims will go on to develop posttraumatic stress disorder (PTSD) or alcohol use disorders (AUD), and development of these disorders is costly to both the victim and society as a whole. Intervening early, in the initial weeks following sexual assault, can provide victims with coping strategies that can decrease the likelihood of developing chronic symptoms. Cognitive approaches for treating symptoms of PTSD have strong empirical support with chronic presentation of symptoms. Less is known about effective strategies for intervening acutely following sexual assault. This project is designed to adapt existing empirically supported cognitive treatment principles for both PTSD and AUD symptoms to be delivered acutely (within 10 weeks of assault) in a brief one session format followed by 4 weekly coaching calls. The first 6 participants enrolled will receive the intervention and provide us with feedback on strengths and weaknesses of the protocol to help us improve it (Open Trial). In the next phase, the pilot testing phase, the study will enroll 38 women to complete the one session intervention followed by 4 once per week coaching calls. Participants will then be assessed again for symptoms of PTSD and alcohol use behavior at 3 month follow-up. This brief intervention group will be compared at the 3 month follow-up to a group of 38 women who receive weekly symptom monitoring only. Thus, this research aims to provide information on the efficacy of the intervention compared to the natural recovery process. This research is significant in its potential to use a very brief and easy to access treatment to decrease the development of chronic psychopathology in a high risk group of women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Cognitive Intervention | Active comparator | Behavioral: Brief Cognitive TherapyOne in person session (90 minutes) of trauma focused cognitive therapy followed by 4 weekly coaching calls (20 minutes each) with the same study therapist |
| Assessment Only | No intervention | –Assessment session followed by weekly completion of assessment measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Identifies as female
- Age > 18 years
- 2-10 weeks post sexual assault
- PTSD symptoms related to recent sexual assault, specifically defined as a minimum of
- 1 reexperiencing, 1 avoidance, 2 negative alterations in mood/cognition, or 2 hyperarousal symptoms
Key exclusion criteria (3 listed)
- Acutely suicidal with intent/plan
- Exhibit current psychosis
- Previous non-response to an adequate trial (8 or more sessions) of Cognitive Processing Therapy (CPT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Cognitive TherapyCognitive strategies to help achieve balanced thinking around sexual assault and alcohol use | Behavioural | Brief Cognitive Intervention |
Primary outcome
Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
Time frame: 12 weeks
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.
Timeline Followback Heavy Episodic Drinking Episodes
Time frame: 12 weeks
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.
1 secondary outcome
Drinking Inventory of Consequences (DrInC)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40925075Bedard-Gilligan MA, Stappenbeck CA, Ojalehto HJ, Dworkin ER, Cadigan JM, Simpson T, Kaysen DL. A pilot randomized controlled trial of cognitive restructuring for PTSD and alcohol misuse following recent sexual assault: Initial efficacy and feasibility. Behav Res Ther. 2025 Oct;193:104847. doi: 10.1016/j.brat.2025.104847. Epub 2025 Aug 28.
- Derived from this study: PubMed 37795783O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
- Individual participant dataSharing planned: No
Related trials for Posttraumatic Stress Disorder
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Recruiting
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Post-Traumatic Stress Disorder
RecruitingPhase 3
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
Major Depression
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Recruiting
Exercise and Emotional Learning in Posttraumatic Stress Disorder
PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Bedard-Gilligan, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Cognitive Therapy in people with Posttraumatic Stress Disorder and Alcohol Use Disorders, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02808468, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.