Alcohol Use DisorderNCT03230006
Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Alcohol Use Disorder and Anxiety Disorders, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Almost 18 million US adults have alcohol use disorders (AUD), with one third of these individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD imposes a high burden via healthcare costs and lost productivity. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Use Disorder, Anxiety Disorders
- What is being tested?
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 31 Jan 2024
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- DSM-5 diagnosis of current major depressive disorder (with the exception of substance-induced depressive disorder) that requires immediate treatment with pharmacologic agents, bipolar disorder, schizophrenia, current bulimia/anorexia, dementia, or other substance dependence, with the exception of nicotine, marijuana, and caffeine dependence.
- Presence of suicidal ideation or history of suicide attempts
- Non-English speakers
- Previously received an adequate trial of cognitive-behavioral therapy (CBT; 8 sessions within the past 5 years)
- Contraindications to MRI scans
- History of head injury with >5-minute loss of consciousness
Show all 10Show fewer
- Pregnancy Note: Women of childbearing potential (not postmenopausal for at least one year) will be required to provide a negative urine pregnancy test prior to each scan.
- Implantation of anything containing magnetically sensitive material including metal plates, aneurysm clips, and cardiac pacemakers, stents; history of sheet metal work, claustrophobia
- Cognitive impairment (MOCA<21).
- Serious medical illness or instability for which hospitalization may be likely within the next year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University, Charles River Campus
Boston, Massachusetts, 02215
About this study
Official title: Efficacy Evaluation of Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders
Almost 18 million US adults have alcohol use disorders (AUD), with one third of these individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD imposes a high burden via healthcare costs and lost productivity. To date, existing treatment approaches for addressing AUD/AXD comorbidity have been only modestly effective and there is a lack of adequate research to guide treatment decisions.
The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has shown efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence from alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with results from this study indicating a reduction from baseline in drinks consumed per day. However, further evaluation of the UP for managing AUD/AXD is warranted.
Read more
In this clinical trial, the investigators will further assess the UP's effectiveness in reducing alcohol consumption in patients with comorbid AUD/AXD. Participants will be randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be used to examine the effects of the UP on changes in brain activity in areas important to regulation of emotional and reward processes implicated in excessive alcohol consumption.
The researchers' primary hypotheses are that the UP group will, compared to the TC group: 1) be superior in acute symptom reduction from pre- to post-treatment, and 2) evidence greater reductions in percent days heavy drinking, percent days of drinking per week, and alcohol craving.
- Conditions
- Alcohol Use Disorder, Anxiety Disorders
- Being tested
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders, Take Control
- Medical subject headings
- Alcoholism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for Transdiagnostic Treatment of Emotional DisordersBehavioural
Also called UP
The UP will be conducted in a standardized fashion over 16 sessions, in a minimum of 16- and a maximum of 21-weeks, following the published therapist guide with minor refinements for application in the proposed comorbid population.
Take ControlBehavioural
Also called TC
TC will be conducted over 12 sessions, in a minimum of 12- and a maximum of 16-weeks. Therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.
| Study group | Role | What they receive |
|---|---|---|
| Unified Protocol | Active comparator | The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) consists of 5 core skills modules based on cognitive behavioral treatment elements of proven effectiveness. As noted above, these core skills modules were designed to target (and have been shown to address) negative emotionality and aversive reactivity to emotional experiences when they occur. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. A final module consists of relapse prevention. As the treatment proceeds, the domains of thoughts, feelings, and behaviors are each explored in detail, focusing specifically on elucidating dysfunctional emotion regulation strategies that the patient has developed over time within each of these domains, and teaching patients more adaptive emotion regulation skills. Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
| Take Control | Placebo comparator | TC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). Receives: Behavioral: Take Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Drinks Consumed Per Week
The Timeline Followback (TLFB) was used to estimate participants' daily drinking during the 90-day period preceding the baseline assessment and was subsequently administered at the beginning of each psychotherapy session and during the follow-up sessions.
Measured: Change from baseline following 12-sessions (Take Control Arm), up to 16 weeks, or 16-sessions (Unified Protocol Arm), up to 21 weeks, of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Mar 2018
- Primary completion31 Aug 2023
- Study completion31 Jan 2024
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 Alcohol Use DisorderStudies 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
- Participants will be randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be used to examine the effects of the UP on changes in brain activity in areas important to regulation of emotional and reward processes implicated in excessive alcohol consumption.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Farchione, Boston University Charles River Campus
- Investigators
- Todd Farchione, PhD, Principal investigator, Boston Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230006
- Sponsor's protocol ID
- R01AA023676
- Status last verified
- Apr 2025
- First submitted
- 24 Jul 2017
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sauer-Zavala S, Boswell JF, Gallagher MW, Bentley KH, Ametaj A, Barlow DH. The role of negative affectivity and negative reactivity to emotions in predicting outcomes in the unified protocol for the transdiagnostic treatment of emotional disorders. Behav Res Ther. 2012 Sep;50(9):551-7. doi: 10.1016/j.brat.2012.05.005. Epub 2012 Jun 9.
PubMed 22738907Boswell JF, Farchione TJ, Sauer-Zavala S, Murray HW, Fortune MR, Barlow DH. Anxiety sensitivity and interoceptive exposure: a transdiagnostic construct and change strategy. Behav Ther. 2013 Sep;44(3):417-31. doi: 10.1016/j.beth.2013.03.006. Epub 2013 Apr 2.
PubMed 23768669
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders
- ClinicalTrials.gov ID
- NCT03230006
- Acronym / sponsor ID
- R01AA023676
- Conditions
- Alcohol Use Disorder, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Posted 25 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Almost 18 million US adults have alcohol use disorders (AUD), with one third of these individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD imposes a high burden via healthcare costs and lost productivity. To date, existing treatment approaches for addressing AUD/AXD comorbidity have been only modestly effective and there is a lack of adequate research to guide treatment decisions.
The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has shown efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence from alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with results from this study indicating a reduction from baseline in drinks consumed per day. However, further evaluation of the UP for managing AUD/AXD is warranted.
In this clinical trial, the investigators will further assess the UP's effectiveness in reducing alcohol consumption in patients with comorbid AUD/AXD. Participants will be randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be used to examine the effects of the UP on changes in brain activity in areas important to regulation of emotional and reward processes implicated in excessive alcohol consumption.
The researchers' primary hypotheses are that the UP group will, compared to the TC group: 1) be superior in acute symptom reduction from pre- to post-treatment, and 2) evidence greater reductions in percent days heavy drinking, percent days of drinking per week, and alcohol craving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be used to examine the effects of the UP on changes in brain activity in areas important to regulation of emotional and reward processes implicated in excessive alcohol consumption.
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol | Active comparator | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersThe Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) consists of 5 core skills modules based on cognitive behavioral treatment elements of proven effectiveness. As noted above, these core skills modules were designed to target (and have been shown to address) negative emotionality and aversive reactivity to emotional experiences when they occur. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. A final module consists of relapse prevention. As the treatment proceeds, the domains of thoughts, feelings, and behaviors are each explored in detail, focusing specifically on elucidating dysfunctional emotion regulation strategies that the patient has developed over time within each of these domains, and teaching patients more adaptive emotion regulation skills. |
| Take Control | Placebo comparator | Behavioral: Take ControlTC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- DSM-5 diagnosis of current major depressive disorder (with the exception of substance-induced depressive disorder) that requires immediate treatment with pharmacologic agents, bipolar disorder, schizophrenia, current bulimia/anorexia, dementia, or other substance dependence, with the exception of nicotine, marijuana, and caffeine dependence.
- Presence of suicidal ideation or history of suicide attempts
- Non-English speakers
- Previously received an adequate trial of cognitive-behavioral therapy (CBT; 8 sessions within the past 5 years)
- Contraindications to MRI scans
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 |
|---|---|---|
| Unified Protocol for Transdiagnostic Treatment of Emotional DisordersAlso: UPThe UP will be conducted in a standardized fashion over 16 sessions, in a minimum of 16- and a maximum of 21-weeks, following the published therapist guide with minor refinements for application in the proposed comorbid population. | Behavioural | Unified Protocol |
| Take ControlAlso: TCTC will be conducted over 12 sessions, in a minimum of 12- and a maximum of 16-weeks. Therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life. | Behavioural | Take Control |
Primary outcome
Mean Number of Drinks Consumed Per Week
Time frame: Change from baseline following 12-sessions (Take Control Arm), up to 16 weeks, or 16-sessions (Unified Protocol Arm), up to 21 weeks, of treatment.
The Timeline Followback (TLFB) was used to estimate participants' daily drinking during the 90-day period preceding the baseline assessment and was subsequently administered at the beginning of each psychotherapy session and during the follow-up sessions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22738907Sauer-Zavala S, Boswell JF, Gallagher MW, Bentley KH, Ametaj A, Barlow DH. The role of negative affectivity and negative reactivity to emotions in predicting outcomes in the unified protocol for the transdiagnostic treatment of emotional disorders. Behav Res Ther. 2012 Sep;50(9):551-7. doi: 10.1016/j.brat.2012.05.005. Epub 2012 Jun 9.
- Background: PubMed 23768669Boswell JF, Farchione TJ, Sauer-Zavala S, Murray HW, Fortune MR, Barlow DH. Anxiety sensitivity and interoceptive exposure: a transdiagnostic construct and change strategy. Behav Ther. 2013 Sep;44(3):417-31. doi: 10.1016/j.beth.2013.03.006. Epub 2013 Apr 2.
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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.
Todd Farchione, PhD principal investigator
Boston Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Alcohol Use Disorder and Anxiety Disorders, run by Boston University Charles River Campus 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 0 inclusion and 10 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 9 Apr 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. Some participants in this study may receive a placebo. 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 25 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?
Mean Number of Drinks Consumed Per Week (time frame: Change from baseline following 12-sessions (Take Control Arm), up to 16 weeks, or 16-sessions (Unified Protocol Arm), up to 21 weeks, of treatment.). 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 NCT03230006, 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 9 Apr 2025.