Alcohol Use Disorder, MildUBANCT05086172
Ultrabrief Behavioral Activation for Reducing Alcohol Use
A study testing Ultrabrief Behavioral Activation in people with Alcohol Use Disorder, Mild and Alcohol Use Disorder, Moderate, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a pilot study to assess feasibility, acceptability, and preliminary efficacy of a single-session ("ultrabrief") psychological intervention to reduce alcohol use in participants with mild to moderate alcohol use disorder (AUD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Mild, Alcohol Use Disorder, Moderate
- What is being tested?
- Ultrabrief Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2022to 10 May 2023
- 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
- Diagnosis of mild or moderate alcohol use disorder based on Diagnostic and Statistical Manual-V (DSM-5) criteria
- Age: 18 years or older
Who cannot join
- Psychotic disorder as determined by the Mini-International Neuropsychiatric Interview (MINI)
- Current suicidality as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
- Diagnosis of severe alcohol or substance use disorder (AUD;SUD) based on MINI
- Receiving concurrent psychotherapy for a mental health-related condition
- Concurrent use of FDA approved medications for the treatment of a substance us disorder
- Change in psychiatric medication in the last four weeks
Show all 9Show fewer
- The inability to give informed, voluntary, written consent to participate
- Inability to communicate effectively in English as determined by interaction with study personnel
- Anything else that in the assessment of the investigational team is not conducive to successful completion of study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516
About this study
This is a pilot study to assess feasibility, acceptability, and preliminary efficacy of a single-session ("ultrabrief") psychological intervention to reduce alcohol use in participants with mild to moderate alcohol use disorder (AUD). The intervention is a condensed form of the Life Enhancement Treatment for Substance Use (LETS ACT), behavioral activation (BA) for co-morbid depression and substance use. The investigators hypothesize that UBA is feasible and acceptable. The investigators hypothesize that UBA will reduce overall total alcohol consumption as determined by self-report measures capturing drinking behavior for the 3 months prior to treatment versus the 3 months after treatment when compared to an "assessment only" condition.
Read the detailed description
This is a pilot study to investigate feasibility, acceptability, and preliminary efficacy of an ultrabrief behavioral activation (UBA) intervention for people with a mild to moderate alcohol use disorder. UBA is a psychotherapy intervention derived from the evidence-based LETS ACT BA treatment for substance use disorder. All clinical interviews and the UBA intervention itself will be audio recorded for the purposes of training and to determine reliability and adherence to diagnostic and treatment protocols. No biological samples or signals are collected in this study. The study comprises a phone screening for eligibility, three in-person study visits (initial baseline assessment (BL), UBA intervention session, and 2-week post-treatment assessment) and two follow up phone call assessments (1 month and 3 months after treatment completion). There will be an "assessment only" study arm that will act as a control group which mirrors all aspects of the intervention arm except the "assessment only" arm will receive no intervention. The ultrabrief behavior activation (UBA) intervention is a condensed version of the LETS ACT intervention. The main treatment elements include: (1) explanation of treatment rationale to facilitate behavior change via increased engagement in values-related activities, (2) identification of participant-specific values via detailed assessment of life areas, values and activities, (3) values-based activity planning and scheduling, and (4) post-treatment planning. The overall goal of BA is to shift from values-incongruent behavior (including alcohol use) to behaviors that provide positive reinforcement and environmental reward with the overall goal of increasing the number of engaged-in, value-based activities. This intervention will take 90 minutes. Following intervention completion, therapists will complete a therapist questionnaire and participants will schedule follow-up assessments to occur 2-weeks, 1-month, and 3-months post-treatment. There will be three follow-up contacts with study participants, one in-person visit occurring 2 weeks after the UBA intervention and two phone-based assessments occurring 1 and 3 months following treatment respectively. Follow-up 1 focuses on the treatment experience whereas Follow-up 2 and 3 focus on change in alcohol use and related behaviors and psychological symptoms.
- Being tested
- Ultrabrief Behavioral Activation
- Medical subject headings
- Alcoholism, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrabrief Behavioral ActivationBehavioural
Also called UBA
The ultrabrief behavior activation (UBA) intervention is a condensed version of the LETS ACT intervention. The main treatment elements include: (1) explanation of treatment rationale to facilitate behavior change via increased engagement in values-related activities, (2) identification of participant-specific values via detailed assessment of life areas, values and activities, (3) values-based activity planning and scheduling, and (4) post-treatment planning. The overall goal of behavioral activation (BA) is to shift from values-incongruent behavior (including alcohol use) to behaviors that provide positive reinforcement and environmental reward with the overall goal of increasing the number of engaged-in, value-based activities. This intervention will take 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| UBA Arm | Experimental | All subjects in this arm will receive ultrabrief behavioral activation therapy via a single, 90-minute session. Receives: Behavioral: Ultrabrief Behavioral Activation |
| Control Arm | No intervention | All subjects in this arm will complete all study assessment instruments collected in the interventional arm but will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility via average rate of enrollment of eligible participants
The investigators will compute the average rate of enrollment of eligible participants when 20 participants have concluded study participation to determine the feasibility of such interventions.
Measured: Through completion of the study, an average of 1 year
Feasibility via computed fraction of participants who have completed all assessment in this study
The investigators will compute the fraction of participants who have completed all assessments in this study (baseline, 2-weeks post treatment, 1-month post treatment-3-months post treatment)
Measured: Baseline up to 3-months Post treatment (Follow up 3)
Acceptability via summary scores and statistics of study-designed treatment engagement and acceptability assessment instruments
Acceptability will be characterized by computing summary scores and their corresponding statistics from the Treatment Engagement and Acceptability Assessment (TEA) designed for this study. Scores on the TEA range from a minimum score of 20 to a maximum score of 100, with higher scores indicating greater treatment engagement and acceptability.
Measured: 2 weeks Post Treatment (2 week follow-up)
Secondary outcomes (4)
Change in alcohol consumption via average amount of alcohol consumed per drinking day
The investigators will compute the change in total alcohol consumption from the three months prior to Baseline up to 3 months post treatment based on the average amount of alcohol consumed per drinking day in the 3 months prior to baseline compared to the average amount of alcohol consumed per drinking day reported in the 3 months post treatment as recorded on the time-line followback (TLFB) in both study arms and assess a pre-treatment, post-treatment difference between groups.
Measured: 3 months prior to Baseline up to 3-months post treatment
Change in alcohol consumption via number of drinking days
The investigators will compute the change in total alcohol consumption from the three months prior to Baseline up to 3 months post treatment based on the number of reported drinking days in the 3 months prior to baseline compared to the number of drinking days reported in the 3 months post treatment as recorded on the time-line followback (TLFB) in both study arms and assess a pre-treatment, post-treatment difference between groups.
Measured: 3 months prior to Baseline up to 3-months post treatment
Feasibility via computed fraction of participants that successfully completed at least 1 of each activity independently as per record in treatment booklet
The investigators will compute the fraction of participants who filled in the treatment booklets in a way that the participants completed at least one of each activity independently at-home (i.e., at least 1 activity and value for at least 3 life areas AND at least 2 alternative activities to alcohol AND at least 1 activity daily for 14 days). This measures feasibility of participants performing work that would be done in-session in longer interventions at home on their own for UBA.
Measured: 2 weeks Post treatment
Feasibility via the therapist questionnaire (TQ) developed by the investigators for this study
The investigators will assemble formal feedback from the form for the therapist to fill out (TQ); 3 sub-scores for material covered, acceptance by participant, and participant engagement. The Material Covered subscale ranges from a minimum score of 0 to a maximum score of 10, with higher scores indicating less thorough material coverage. The Acceptance sub-scale ranges from a minimum score of 4 to a maximum score of 20, with higher scores indicating higher levels of acceptance. The Participant Engagement sub-scale ranges from a minimum score of 5 to a maximum score of 25, with higher scores indicating higher levels of participant engagement.
Measured: Immediately following Treatment Session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start8 Mar 2022
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder, MildStudies 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
- Model description
- This is an early pilot study that will compare an interventional assignment group to an "assessment only" control. The focus is on feasibility and acceptance of such a short intervention. The intervention is an ultrabrief, single-session (90 minute) administration of UBA, a psychotherapy intervention derived from the evidence-based LETS ACT Behavioral Activation treatment for substance use disorder. However, the investigators will also measure the difference of change in alcohol use behavior between groups as an additional outcome to gain an initial understanding of the magnitude of the effect for the design of future controlled studies.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy Daughters, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086172
- Sponsor's protocol ID
- 21-1369
- Acronym
- UBA
- Status last verified
- Jul 2023
- First submitted
- 24 Sep 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected during the trial, after de-identification.
Publications
Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238.
PubMed 15010446Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.
PubMed 17716083Babor TF, Del Boca F, Bray JW. Screening, Brief Intervention and Referral to Treatment: implications of SAMHSA's SBIRT initiative for substance abuse policy and practice. Addiction. 2017 Feb;112 Suppl 2:110-117. doi: 10.1111/add.13675.
PubMed 28074569Miller WR, Wilbourne PL. Mesa Grande: a methodological analysis of clinical trials of treatments for alcohol use disorders. Addiction. 2002 Mar;97(3):265-77. doi: 10.1046/j.1360-0443.2002.00019.x.
PubMed 11964100Gawrysiak, M., C. Nicholas, and D.R. Hopko, Behavioral activation for moderately depressed university students: Randomized controlled trial. Journal of Counseling Psychology, 2009. 56(3): p. 468-475.
Parra, P.A.R., J.I. Uribe, and J.M. Bianchi, Effectiveness of a Single Session Protocol of Behavioral Activation in College Students with Depressive Symptomatology. International journal of psychology and psychological therapy, 2019. 19(1): p. 5-14
Daughters SB, Magidson JF, Anand D, Seitz-Brown CJ, Chen Y, Baker S. The effect of a behavioral activation treatment for substance use on post-treatment abstinence: a randomized controlled trial. Addiction. 2018 Mar;113(3):535-544. doi: 10.1111/add.14049. Epub 2017 Nov 19.
PubMed 28963853Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.
PubMed 8991972Blanchard KA, Morgenstern J, Morgan TJ, Lobouvie EW, Bux DA. Assessing consequences of substance use: psychometric properties of the inventory of drug use consequences. Psychol Addict Behav. 2003 Dec;17(4):328-31. doi: 10.1037/0893-164X.17.4.328.
PubMed 14640829Carver, C. S., & White, T. L. (1994). Behavioral inhibition, behavioral activation, and affective responses to impending reward and punishment: The BIS/BAS scales. Journal of Personality and Social Psychology, 67, 319-333
Carvalho JP, Gawrysiak MJ, Hellmuth JC, McNulty JK, Magidson JF, Lejuez CW, Hopko DR. The reward probability index: design and validation of a scale measuring access to environmental reward. Behav Ther. 2011 Jun;42(2):249-62. doi: 10.1016/j.beth.2010.05.004. Epub 2011 Jan 18.
PubMed 21496510Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417First, M. B., Gibbon, M., Spitzer, R. L., Williams, J. B. W., & Benjamin, L. S. (1997). Structured Clinical Interview for DSM-IV Axis II personality disorders (SCID-II). Washington, DC: American Psychiatric Press.
Hatcher, R. L., & Gillaspy, J. A. (2006). Development and validation of a revised short version of the Working Alliance Inventory. Psychotherapy Research, 16(1), 12-25. https://doi.org/10.1080/10503300500352500
Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
PubMed 1932883
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrabrief Behavioral Activation for Reducing Alcohol Use
- ClinicalTrials.gov ID
- NCT05086172
- Acronym / sponsor ID
- UBA / 21-1369
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 20 Oct 2021 (actual)
- 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 is a pilot study to assess feasibility, acceptability, and preliminary efficacy of a single-session ("ultrabrief") psychological intervention to reduce alcohol use in participants with mild to moderate alcohol use disorder (AUD). The intervention is a condensed form of the Life Enhancement Treatment for Substance Use (LETS ACT), behavioral activation (BA) for co-morbid depression and substance use. The investigators hypothesize that UBA is feasible and acceptable. The investigators hypothesize that UBA will reduce overall total alcohol consumption as determined by self-report measures capturing drinking behavior for the 3 months prior to treatment versus the 3 months after treatment when compared to an "assessment only" condition.
Detailed description
This is a pilot study to investigate feasibility, acceptability, and preliminary efficacy of an ultrabrief behavioral activation (UBA) intervention for people with a mild to moderate alcohol use disorder. UBA is a psychotherapy intervention derived from the evidence-based LETS ACT BA treatment for substance use disorder. All clinical interviews and the UBA intervention itself will be audio recorded for the purposes of training and to determine reliability and adherence to diagnostic and treatment protocols. No biological samples or signals are collected in this study. The study comprises a phone screening for eligibility, three in-person study visits (initial baseline assessment (BL), UBA intervention session, and 2-week post-treatment assessment) and two follow up phone call assessments (1 month and 3 months after treatment completion). There will be an "assessment only" study arm that will act as a control group which mirrors all aspects of the intervention arm except the "assessment only" arm will receive no intervention. The ultrabrief behavior activation (UBA) intervention is a condensed version of the LETS ACT intervention. The main treatment elements include: (1) explanation of treatment rationale to facilitate behavior change via increased engagement in values-related activities, (2) identification of participant-specific values via detailed assessment of life areas, values and activities, (3) values-based activity planning and scheduling, and (4) post-treatment planning. The overall goal of BA is to shift from values-incongruent behavior (including alcohol use) to behaviors that provide positive reinforcement and environmental reward with the overall goal of increasing the number of engaged-in, value-based activities. This intervention will take 90 minutes. Following intervention completion, therapists will complete a therapist questionnaire and participants will schedule follow-up assessments to occur 2-weeks, 1-month, and 3-months post-treatment. There will be three follow-up contacts with study participants, one in-person visit occurring 2 weeks after the UBA intervention and two phone-based assessments occurring 1 and 3 months following treatment respectively. Follow-up 1 focuses on the treatment experience whereas Follow-up 2 and 3 focus on change in alcohol use and related behaviors and psychological symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an early pilot study that will compare an interventional assignment group to an "assessment only" control. The focus is on feasibility and acceptance of such a short intervention. The intervention is an ultrabrief, single-session (90 minute) administration of UBA, a psychotherapy intervention derived from the evidence-based LETS ACT Behavioral Activation treatment for substance use disorder. However, the investigators will also measure the difference of change in alcohol use behavior between groups as an additional outcome to gain an initial understanding of the magnitude of the effect for the design of future controlled studies.
| Arm | Type | Receives |
|---|---|---|
| UBA Arm | Experimental | Behavioral: Ultrabrief Behavioral ActivationAll subjects in this arm will receive ultrabrief behavioral activation therapy via a single, 90-minute session. |
| Control Arm | No intervention | –All subjects in this arm will complete all study assessment instruments collected in the interventional arm but will not receive an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of mild or moderate alcohol use disorder based on Diagnostic and Statistical Manual-V (DSM-5) criteria
- Age: 18 years or older
Key exclusion criteria (9 listed)
- Psychotic disorder as determined by the Mini-International Neuropsychiatric Interview (MINI)
- Current suicidality as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
- Diagnosis of severe alcohol or substance use disorder (AUD;SUD) based on MINI
- Receiving concurrent psychotherapy for a mental health-related condition
- Concurrent use of FDA approved medications for the treatment of a substance us disorder
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 |
|---|---|---|
| Ultrabrief Behavioral ActivationAlso: UBAThe ultrabrief behavior activation (UBA) intervention is a condensed version of the LETS ACT intervention. The main treatment elements include: (1) explanation of treatment rationale to facilitate behavior change via increased engagement in values-related activities, (2) identification of participant-specific values via detailed assessment of life areas, values and activities, (3) values-based activity planning and scheduling, and (4) post-treatment planning. The overall goal of behavioral activation (BA) is to shift from values-incongruent behavior (including alcohol use) to behaviors that provide positive reinforcement and environmental reward with the overall goal of increasing the number of engaged-in, value-based activities. This intervention will take 90 minutes. | Behavioural | UBA Arm |
Primary outcome
Feasibility via average rate of enrollment of eligible participants
Time frame: Through completion of the study, an average of 1 year
The investigators will compute the average rate of enrollment of eligible participants when 20 participants have concluded study participation to determine the feasibility of such interventions.
Feasibility via computed fraction of participants who have completed all assessment in this study
Time frame: Baseline up to 3-months Post treatment (Follow up 3)
The investigators will compute the fraction of participants who have completed all assessments in this study (baseline, 2-weeks post treatment, 1-month post treatment-3-months post treatment)
Acceptability via summary scores and statistics of study-designed treatment engagement and acceptability assessment instruments
Time frame: 2 weeks Post Treatment (2 week follow-up)
Acceptability will be characterized by computing summary scores and their corresponding statistics from the Treatment Engagement and Acceptability Assessment (TEA) designed for this study. Scores on the TEA range from a minimum score of 20 to a maximum score of 100, with higher scores indicating greater treatment engagement and acceptability.
4 secondary outcomes
Change in alcohol consumption via average amount of alcohol consumed per drinking day
Time frame: 3 months prior to Baseline up to 3-months post treatment
Change in alcohol consumption via number of drinking days
Time frame: 3 months prior to Baseline up to 3-months post treatment
Feasibility via computed fraction of participants that successfully completed at least 1 of each activity independently as per record in treatment booklet
Time frame: 2 weeks Post treatment
Feasibility via the therapist questionnaire (TQ) developed by the investigators for this study
Time frame: Immediately following Treatment Session
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 27 Jul 2023.
- Background: PubMed 15010446Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238.
- Background: PubMed 17716083Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.
- Background: PubMed 28074569Babor TF, Del Boca F, Bray JW. Screening, Brief Intervention and Referral to Treatment: implications of SAMHSA's SBIRT initiative for substance abuse policy and practice. Addiction. 2017 Feb;112 Suppl 2:110-117. doi: 10.1111/add.13675.
- Background: PubMed 11964100Miller WR, Wilbourne PL. Mesa Grande: a methodological analysis of clinical trials of treatments for alcohol use disorders. Addiction. 2002 Mar;97(3):265-77. doi: 10.1046/j.1360-0443.2002.00019.x.
- BackgroundGawrysiak, M., C. Nicholas, and D.R. Hopko, Behavioral activation for moderately depressed university students: Randomized controlled trial. Journal of Counseling Psychology, 2009. 56(3): p. 468-475.
- BackgroundParra, P.A.R., J.I. Uribe, and J.M. Bianchi, Effectiveness of a Single Session Protocol of Behavioral Activation in College Students with Depressive Symptomatology. International journal of psychology and psychological therapy, 2019. 19(1): p. 5-14
- Background: PubMed 28963853Daughters SB, Magidson JF, Anand D, Seitz-Brown CJ, Chen Y, Baker S. The effect of a behavioral activation treatment for substance use on post-treatment abstinence: a randomized controlled trial. Addiction. 2018 Mar;113(3):535-544. doi: 10.1111/add.14049. Epub 2017 Nov 19.
- Background: PubMed 8991972Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.
- Background: PubMed 14640829Blanchard KA, Morgenstern J, Morgan TJ, Lobouvie EW, Bux DA. Assessing consequences of substance use: psychometric properties of the inventory of drug use consequences. Psychol Addict Behav. 2003 Dec;17(4):328-31. doi: 10.1037/0893-164X.17.4.328.
- BackgroundCarver, C. S., & White, T. L. (1994). Behavioral inhibition, behavioral activation, and affective responses to impending reward and punishment: The BIS/BAS scales. Journal of Personality and Social Psychology, 67, 319-333
- Background: PubMed 21496510Carvalho JP, Gawrysiak MJ, Hellmuth JC, McNulty JK, Magidson JF, Lejuez CW, Hopko DR. The reward probability index: design and validation of a scale measuring access to environmental reward. Behav Ther. 2011 Jun;42(2):249-62. doi: 10.1016/j.beth.2010.05.004. Epub 2011 Jan 18.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Co-Investigator's Lab WebsiteLink provided by the sponsor.
- Study Research for Me with study information and links for interested individualsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the trial, after de-identification.
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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.
Stacy Daughters, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrabrief Behavioral Activation in people with Alcohol Use Disorder, Mild and Alcohol Use Disorder, Moderate, run by University of North Carolina, Chapel Hill 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 2 inclusion and 9 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 27 Jul 2023. 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?
Feasibility via average rate of enrollment of eligible participants (time frame: Through completion of the study, an average of 1 year). The study lists 3 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 NCT05086172, which also lists 28 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 27 Jul 2023.