Traumatic Brain InjuryNCT02129361
Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury
A study testing Adapted Screening and Brief Intervention (Adapted SBI) in people with Traumatic Brain Injury, run by Jennifer Bogner, PhD, ABPP at 1 site in United States.
Trial summary
This study is investigating one way to improve health and healthy habits after traumatic brain injury (TBI). The primary goal of this study is to determine if a brief intervention accommodated for persons with moderate or severe TBI is effective in reducing alcohol misuse during the year following injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Adapted Screening and Brief Intervention (Adapted SBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Sustained a TBI, defined as damage to brain tissue caused by external force and evidenced by loss of consciousness, post-traumatic amnesia, skull fracture, or objective neurological findings
- History of alcohol misuse within the year prior to injury
- Be at least 18 years old
- English-speaking
- Have cleared post-traumatic amnesia
- Able and willing to provide informed consent
Who cannot join
- Language impairments that would preclude participation in interview
- Has not cleared post-traumatic amnesia before discharge
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Brief Intervention for Substance Misuse Following Moderate or Severe Traumatic Brain Injury (TBI): A Randomized Controlled Trial
This study is investigating one way to improve health and healthy habits after traumatic brain injury (TBI). The primary goal of this study is to determine if a brief intervention accommodated for persons with moderate or severe TBI is effective in reducing alcohol misuse during the year following injury. It is hypothesized that an adapted Screening, Education and Brief Intervention (adapted SBI) will reduce the number of alcoholic drinks consumed per week over the year following discharge from inpatient rehabilitation, in comparison to a Screening and Education Attention Control condition (SEA control).
- Conditions
- Traumatic Brain Injury
- Being tested
- Adapted Screening and Brief Intervention (Adapted SBI), Screening & Education Attention Control
- Keywords
- traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Screening and Brief Intervention (Adapted SBI)Behavioural
Screening & Education Attention ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Adapted Screening and Brief Intervention | Experimental | Adapted Screening and Brief Intervention: Participants will be screened for substance use, receive education regarding the effects of substance misuse, participate in a motivation interview, and participate in a booster session one month later Receives: Behavioral: Adapted Screening and Brief Intervention (Adapted SBI) |
| Screening & Education Attention Control | Active comparator | Screening \& Education Attention Control: Participants will be screened for substance use, receive education regarding the effects of substance misuse, and participate in a booster session one month later Receives: Behavioral: Screening & Education Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of alcoholic drinks consumed per week in past month
Number of drinks will be recorded at baseline, 6, 9, and 12 months. We will be measuring change in the number of drinks consumed of the course of the year, with the primary outcome being measured at the 12 month assessment.
Measured: Change from baseline to 12 months post-discharge
Secondary outcomes (11)
Frequency of alcohol binges in past month
Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men
Measured: Change in the number of alcohol binges baseline to 12 months post-discharge
Alcohol expectancies
Measured by the shortened Alcohol Expectancies Questionnaire-III
Measured: 12 months post-discharge
Number of facts retained about negative consequences of substance misuse
Count of number of facts, maximum=8
Measured: 12 months post-discharge
Number of alcoholic drinks consumed per week during the past month
Count of number of facts, maximum=8
Measured: Change from baseline to 3 months post-discharge
Number of alcoholic drinks consumed per week in the past month
Measured: Change from baseline to 6 months post-discharge
Frequency of alcohol binges in past month
Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men
Measured: Change from baseline to 6 months post-discharge
Number of alcohol binges in past month
Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men
Measured: Change from baseline to 3 months post-discharge
Alcohol expectancies
Measured by the shortened Alcohol Expectancies Questionnaire-III
Measured: 6 months post-discharge
Alcohol expectancies
Measured by the shortened Alcohol Expectancies Questionnaire-III
Measured: 3 months post-discharge
Number of facts retained about negative consequences of alcohol use
Count of number of facts, maximum=8
Measured: 3 months post-discharge
Number of facts retained about negative consequences of alcohol use
Count of number of facts, maximum=8
Measured: 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMar 2014
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Bogner, PhD, ABPP
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor-investigator, Jennifer Bogner, PhD, ABPP, Ohio State University
- Investigators
- Jennifer A Bogner, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129361
- Sponsor's protocol ID
- 2012H0424
- Status last verified
- Oct 2021
- First submitted
- 28 Apr 2014
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Bogner J, Corrigan JD, Peng J, Kane C, Coxe K. Comparative effectiveness of a brief intervention for alcohol misuse following traumatic brain injury: A randomized controlled trial. Rehabil Psychol. 2021 Nov;66(4):345-355. doi: 10.1037/rep0000405. Epub 2021 Oct 7.
PubMed 34618511
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention for Substance Misuse Following Moderate or Severe Traumatic Brain Injury (TBI): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02129361
- Acronym / sponsor ID
- 2012H0424
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Jennifer Bogner, PhD, ABPPUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Mar 2014
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is investigating one way to improve health and healthy habits after traumatic brain injury (TBI). The primary goal of this study is to determine if a brief intervention accommodated for persons with moderate or severe TBI is effective in reducing alcohol misuse during the year following injury. It is hypothesized that an adapted Screening, Education and Brief Intervention (adapted SBI) will reduce the number of alcoholic drinks consumed per week over the year following discharge from inpatient rehabilitation, in comparison to a Screening and Education Attention Control condition (SEA control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Screening and Brief Intervention | Experimental | Behavioral: Adapted Screening and Brief Intervention (Adapted SBI)Adapted Screening and Brief Intervention: Participants will be screened for substance use, receive education regarding the effects of substance misuse, participate in a motivation interview, and participate in a booster session one month later |
| Screening & Education Attention Control | Active comparator | Behavioral: Screening & Education Attention ControlScreening \& Education Attention Control: Participants will be screened for substance use, receive education regarding the effects of substance misuse, and participate in a booster session one month later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sustained a TBI, defined as damage to brain tissue caused by external force and evidenced by loss of consciousness, post-traumatic amnesia, skull fracture, or objective neurological findings
- History of alcohol misuse within the year prior to injury
- Be at least 18 years old
- English-speaking
- Have cleared post-traumatic amnesia
Key exclusion criteria (2 listed)
- Language impairments that would preclude participation in interview
- Has not cleared post-traumatic amnesia before discharge
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 |
|---|---|---|
| Adapted Screening and Brief Intervention (Adapted SBI) | Behavioural | Adapted Screening and Brief Intervention |
| Screening & Education Attention Control | Behavioural | Screening & Education Attention Control |
Primary outcome
Number of alcoholic drinks consumed per week in past month
Time frame: Change from baseline to 12 months post-discharge
Number of drinks will be recorded at baseline, 6, 9, and 12 months. We will be measuring change in the number of drinks consumed of the course of the year, with the primary outcome being measured at the 12 month assessment.
11 secondary outcomes
Frequency of alcohol binges in past month
Time frame: Change in the number of alcohol binges baseline to 12 months post-discharge
Alcohol expectancies
Time frame: 12 months post-discharge
Number of facts retained about negative consequences of substance misuse
Time frame: 12 months post-discharge
Number of alcoholic drinks consumed per week during the past month
Time frame: Change from baseline to 3 months post-discharge
Number of alcoholic drinks consumed per week in the past month
Time frame: Change from baseline to 6 months post-discharge
Frequency of alcohol binges in past month
Time frame: Change from baseline to 6 months post-discharge
Number of alcohol binges in past month
Time frame: Change from baseline to 3 months post-discharge
Alcohol expectancies
Time frame: 6 months post-discharge
Alcohol expectancies
Time frame: 3 months post-discharge
Number of facts retained about negative consequences of alcohol use
Time frame: 3 months post-discharge
Number of facts retained about negative consequences of alcohol use
Time frame: 6 months post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Derived from this study: PubMed 34618511Bogner J, Corrigan JD, Peng J, Kane C, Coxe K. Comparative effectiveness of a brief intervention for alcohol misuse following traumatic brain injury: A randomized controlled trial. Rehabil Psychol. 2021 Nov;66(4):345-355. doi: 10.1037/rep0000405. Epub 2021 Oct 7.
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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.
Jennifer A Bogner, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Screening and Brief Intervention (Adapted SBI) in people with Traumatic Brain Injury, run by Jennifer Bogner, PhD, ABPP 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 6 inclusion and 2 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 21 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of alcoholic drinks consumed per week in past month (time frame: Change from baseline to 12 months post-discharge). 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 NCT02129361, which also lists 1 linked publication.
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 21 Oct 2021.