Alcohol DrinkingAMPNCT01886716
Retraining Attention to Treat Alcohol Dependence and Social Anxiety
A study testing Anxiety Attention Training and Alcohol Attention Training in people with Alcohol Drinking and Anxiety Disorders, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research is to test a computerized intervention for people with co-occurring social anxiety and alcohol dependence. The intervention seeks to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking, Anxiety Disorders
- What is being tested?
- Anxiety Attention Training and Alcohol Attention Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2014
- 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
- Current alcohol dependence
- Elevated social anxiety symptoms
- Willingness to consider cutting down on drinking
Who cannot join
- Current psychosis
- Unmanaged manic symptoms
- Significant cognitive impairment
- Other drug use in past month
- Receiving cognitive behavioral therapy for alcohol use disorder or social anxiety
- Unable to read
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Department of Family and Community Medicine
Cincinnati, Ohio, 45206
About this study
Official title: Cognitive Bias Modification: A Novel Intervention for Alcohol Dependence and Social Anxiety
The purpose of this research is to test a computerized intervention for people with co-occurring social anxiety and alcohol dependence. The intervention seeks to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. The investigators expect that participants receiving alcohol or anxiety training will experience reductions in those specific symptoms compared to participants in a control condition. The investigators also expect that participants receiving combined alcohol and anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative to participants in any other condition.
Read the detailed description
Alcohol Use Disorders (AUDs) and Social Anxiety Disorder are disabling and chronic conditions. In spite of these common and significantly overlapping problems, insight into the mechanisms linking alcohol dependence and social anxiety symptoms is minimal, and there are not well established treatment guidelines for this population. In this study, the investigators seek to develop a computerized intervention for individuals with symptoms of social anxiety and alcohol dependence. The intervention attempts to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. The investigators expect that participants receiving alcohol or anxiety training will experience reductions in those specific symptoms compared to participants in a control condition. The investigators also expect that participants receiving combined alcohol and anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative to participants in any other condition.
- Conditions
- Alcohol Drinking, Anxiety Disorders
- Being tested
- Anxiety Attention Training, Alcohol Attention Training, Control Training
- Keywords
- Alcohol Abuse, Alcohol Dependence, Alcohol Drinking, Social Anxiety, Social Phobia, Anxiety Disorders
- Medical subject headings
- Alcohol Drinking, Anxiety Disorders, Alcoholism, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety Attention TrainingBehavioural
Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.
Alcohol Attention TrainingBehavioural
Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol.
Control TrainingBehavioural
Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol.
| Study group | Role | What they receive |
|---|---|---|
| Anxiety Attention Training only | Experimental | Participants will receive Anxiety Attention Training and placebo Alcohol training. Receives: Behavioral: Anxiety Attention Training |
| Alcohol Attention Training only | Experimental | Participants will receive Alcohol Attention Training and placebo Anxiety training. Receives: Behavioral: Alcohol Attention Training |
| Anxiety + Alcohol Attention Training | Experimental | Participants will receive both Anxiety Attention Training and Alcohol Attention Training. Receives: Behavioral: Anxiety Attention Training; Behavioral: Alcohol Attention Training |
| Control Training | Placebo comparator | Participants will receive placebo Anxiety Training and placebo Alcohol training. Receives: Behavioral: Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale
The experimenter-administered Liebowitz Social Anxiety Scale (Liebowitz, 1987) was the primary measure to assess social anxiety symptoms. This well-validated instrument assesses fear and avoidance across a range of 24 social and performance situations during the course of the previous week. A total LSAS score was computed, ranging from 0 (no fear or avoidance) to 144 (the greatest level of fear and avoidance).
Measured: Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
The Daily Drinking Questionnaire
The Daily Drinking Questionnaire (Collins, Parks, \& Marlatt, 1985) was the primary measure used to assess weekly alcohol consumption. This calendar-based measure was administered by the experimenter once per week to monitor changes in symptoms. The measure assessed the total number of drinks in the past week.
Measured: Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionDec 2014
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.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Miami University, Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Joshua Magee, University of Cincinnati
- Investigators
- Joshua C Magee, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886716
- Sponsor's protocol ID
- 1R21AA021151
- Other IDs
- 1R21AA021151
- Acronym
- AMP
- Status last verified
- Dec 2016
- First submitted
- 17 Jun 2013
- Last updated
- 28 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Bias Modification: A Novel Intervention for Alcohol Dependence and Social Anxiety
- ClinicalTrials.gov ID
- NCT01886716
- Acronym / sponsor ID
- AMP / 1R21AA021151
- Conditions
- Alcohol Drinking, Anxiety Disorders
- Keywords
- Alcohol Abuse, Alcohol Dependence, Alcohol Drinking, Social Anxiety, Social Phobia, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Miami University, Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Posted 28 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to test a computerized intervention for people with co-occurring social anxiety and alcohol dependence. The intervention seeks to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. The investigators expect that participants receiving alcohol or anxiety training will experience reductions in those specific symptoms compared to participants in a control condition. The investigators also expect that participants receiving combined alcohol and anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative to participants in any other condition.
Detailed description
Alcohol Use Disorders (AUDs) and Social Anxiety Disorder are disabling and chronic conditions. In spite of these common and significantly overlapping problems, insight into the mechanisms linking alcohol dependence and social anxiety symptoms is minimal, and there are not well established treatment guidelines for this population. In this study, the investigators seek to develop a computerized intervention for individuals with symptoms of social anxiety and alcohol dependence. The intervention attempts to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. The investigators expect that participants receiving alcohol or anxiety training will experience reductions in those specific symptoms compared to participants in a control condition. The investigators also expect that participants receiving combined alcohol and anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative to participants in any other condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anxiety Attention Training only | Experimental | Behavioral: Anxiety Attention TrainingParticipants will receive Anxiety Attention Training and placebo Alcohol training. |
| Alcohol Attention Training only | Experimental | Behavioral: Alcohol Attention TrainingParticipants will receive Alcohol Attention Training and placebo Anxiety training. |
| Anxiety + Alcohol Attention Training | Experimental | Behavioral: Anxiety Attention Training, Behavioral: Alcohol Attention TrainingParticipants will receive both Anxiety Attention Training and Alcohol Attention Training. |
| Control Training | Placebo comparator | Behavioral: Control TrainingParticipants will receive placebo Anxiety Training and placebo Alcohol training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current alcohol dependence
- Elevated social anxiety symptoms
- Willingness to consider cutting down on drinking
Key exclusion criteria (6 listed)
- Current psychosis
- Unmanaged manic symptoms
- Significant cognitive impairment
- Other drug use in past month
- Receiving cognitive behavioral therapy for alcohol use disorder or social anxiety
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 |
|---|---|---|
| Anxiety Attention TrainingAnxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety. | Behavioural | Anxiety + Alcohol Attention Training, Anxiety Attention Training only |
| Alcohol Attention TrainingAlcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol. | Behavioural | Alcohol Attention Training only, Anxiety + Alcohol Attention Training |
| Control TrainingPlacebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol. | Behavioural | Control Training |
Primary outcome
Liebowitz Social Anxiety Scale
Time frame: Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
The experimenter-administered Liebowitz Social Anxiety Scale (Liebowitz, 1987) was the primary measure to assess social anxiety symptoms. This well-validated instrument assesses fear and avoidance across a range of 24 social and performance situations during the course of the previous week. A total LSAS score was computed, ranging from 0 (no fear or avoidance) to 144 (the greatest level of fear and avoidance).
The Daily Drinking Questionnaire
Time frame: Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
The Daily Drinking Questionnaire (Collins, Parks, \& Marlatt, 1985) was the primary measure used to assess weekly alcohol consumption. This calendar-based measure was administered by the experimenter once per week to monitor changes in symptoms. The measure assessed the total number of drinks in the past week.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Joshua C Magee, Ph.D. principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety Attention Training and Alcohol Attention Training in people with Alcohol Drinking and Anxiety Disorders, run by University of Cincinnati 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 3 inclusion and 6 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 28 Dec 2016. 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 28 Dec 2016). 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?
Liebowitz Social Anxiety Scale (time frame: Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)). 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?
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 28 Dec 2016.