Alcohol Use DisorderFITNCT03428490
Treatment for Comorbid Social Anxiety and Alcohol Use Disorders.
A study testing Fully integrated treatment and Stand-alone Intensive Outpatient Program in people with Alcohol Use Disorder and Social Anxiety Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Alcohol use disorders (AUD) and social anxiety disorder (SAD) are highly comorbid and associated with significant impairment. Social anxiety comorbidity is associated with poorer addiction treatment engagement and outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Social Anxiety Disorder
- What is being tested?
- Fully integrated treatment and Stand-alone Intensive Outpatient Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 30 Apr 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be currently enrolled in the IOP at Matrix Institute (our community partner) for the treatment of their alcohol use disorder;
- fluent in English;
- meet the DSM-5 criteria for social anxiety disorder and alcohol use disorder
Who cannot join
- marked cognitive impairment
- moderate to severe suicidality
- unstable manic or psychotic symptoms.
Trial locations and contacts
1 site in 1 country.
United States1 site
Matrix Institute on Addictions
Los Angeles, California, 90025
About this study
Official title: Developing and Evaluating a Fully Integrated Treatment Program for Comorbid Social Anxiety and Alcohol Use Disorders
Alcohol use disorders (AUD) and social anxiety disorder (SAD) are highly comorbid and associated with significant impairment. Social anxiety comorbidity is associated with poorer addiction treatment engagement and outcomes. Thus, addressing underlying SAD symptoms that may lead to and maintain alcohol problems, as well as undermine successful treatment for AUD, is warranted. This proposal aims to develop and evaluate a fully integrated outpatient program for comorbid SAD and AUD that weaves evidence-based treatment for SAD (i.e., exposure-based cognitive behavioral therapy) into a traditional, evidence-based treatment for AUD.
First, the investigators will develop the protocol for the fully integrated treatment (FIT). The overarching goal of FIT will be to simultaneously deliver AUD and SAD treatment. Development will be an iterative process guided by previous research (including our own), and by input from clinicians, administrators, and patients in an outpatient substance use disorder treatment clinic. After the protocol is developed, the investigators will use their established clinician training procedures to train clinicians at their community partnered clinic to competently deliver the intervention. After protocol development and clinician training, the investigators will conduct a pilot randomized clinical trial (RCT) comparing the efficacy of our fully integrated treatment (FIT) for comorbid alcohol use and social anxiety disorders to usual care (UC) in the community substance use disorder specialty clinic. The goals of the RCT will be to gather data regarding acceptability, feasibility, and preliminary efficacy of the FIT protocol. The investigators will randomize treatment-seeking participants (N = 60) who have comorbid SAD and AUD. The investigators will assess treatment engagement, social anxiety outcomes, and alcohol use outcomes at baseline, 3-months, and 6-months from baseline. The investigators will also gather qualitative and quantitative acceptability data from patients after completing FIT, which may guide final refinements of FIT prior to testing in a larger-scale grant.
The knowledge gained from this investigation has the potential to significantly improve the treatment of alcohol use disorders and make a significant public health impact. The focus on direct translation to community practice paradigms and the emphasis on full mental health and addiction treatment integration significantly advance the field.
Read the detailed description
In this study, potential participants will be screened either by University of California, Los Angeles (UCLA) staff or at the Matrix Institute on Addiction to determine whether they may have social anxiety and alcohol use disorder symptoms. If they screen positive for these symptoms, they will be invited to come in for a comprehensive baseline assessment consisting of interviews, questionnaires, and a behavioral assessment. Eligible participants will be randomly assigned to either receive standard Matrix treatment consisting of a 9-hour per week Intensive Outpatient Program (IOP) lasting approximate 2-3 months; or FIT, an Intensive Outpatient Program (also 9 hours per week for approximately 2-3 months) consisting of cognitive behavioral therapy (CBT) for social anxiety disorder that is woven into the alcohol recovery program. After treatment, participants will complete another assessment, and then will complete one several months later.
- Conditions
- Alcohol Use Disorder, Social Anxiety Disorder
- Being tested
- Fully integrated treatment, Stand-alone Intensive Outpatient Program
- Keywords
- Integrated Treatment, Alcohol Use Disorder, Social Anxiety Disorder, Comorbidity, Cognitive Behavioral Therapy
- Medical subject headings
- Alcoholism, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully integrated treatmentBehavioural
Clinicians will be delivering CBT for Social Anxiety Disorder directly into the context of the Matrix's evidence-based treatment for substance use disorders (i.e., The Matrix Model).
Stand-alone Intensive Outpatient ProgramBehavioural
Evidence-based treatment for substance use disorders (i.e., The Matrix Model).
| Study group | Role | What they receive |
|---|---|---|
| Fully Integrated Treatment | Experimental | Evidence-based substance use treatment combined with Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder Intervention name: Fully integrated treatment Receives: Behavioral: Fully integrated treatment |
| Usual Intensive Outpatient Care | Active comparator | Evidence-based substance use disorder treatment Intervention name: Stand-alone Intensive Outpatient Program Receives: Behavioral: Stand-alone Intensive Outpatient Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Alcohol consumption at 3 and 6 months
The Timeline Followback (TLFB), a gold standard semi-structured interview measure of alcohol consumption, will be used in order to obtain number of drinking days
Measured: Baseline, 3 months, and 6 months
Change from Baseline Social Anxiety Symptoms in Situations at 3 and 6 months
The Leibowitz Social Anxiety Scale-Self Report (LSAS-SR) will be used to assess the extent to which individuals are anxious in, and avoid, a variety of social situations, including performance based and social-interactional situations. Anxiety and avoidance are each rated from 1 (none/never) to 4 (extreme/always) Higher scores indicate greater severity of social anxiety.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (7)
Change from Baseline Social anxiety-related drinking motives at 3 and 6 months
This will be assessed using the Drinking to Cope with Social Anxiety Scale (DCSAS), which measures drinking behavior in social situations. The score on the measure is out of 72, with a minimum score of 0 indicating the least amount of avoidance/drinking to scope in situations, and 72 indicating the most amount of avoidance/drinking to scope in situations
Measured: Baseline, 3 months, and 6 months
Change from Baseline Quality of Life and overall functioning at 3 and 6 months
This will be assessed using the Short Form (SF-8), which is a generic quality of life measure with 8 items. The total score is out of 41, with a minimum score of 8 indicating best quality of life score and a maximum score or 41 indicating worst quality of life score.
Measured: Baseline, 3 months, and 6 months
Change from Baseline Alcohol Problems at 3 and 6 months
The Short Inventory of Problems, a dimensional measure of alcohol-related consequences, will be used using "past month" as the time frame for each assessment.
Measured: Baseline, 3 months, and 6 months
Change from Baseline Alcohol Drinks per Day at 3 and 6 months
The Timeline Followback (TLFB) will be used in order to obtain average drinks per drinking day
Measured: Baseline, 3 months, and 6 months
Change from Baseline Heavy Alcohol Use Days at 3 and 6 months
The Timeline Followback (TLFB) will be used in order to obtain % of heavy drinking days (defined as ≥4 drinks per day for women and ≥5 drinks per day for men)
Measured: Baseline, 3 months, and 6 months
Change from Baseline Alcohol Abstinence at 3 and 6 months
The Timeline Followback (TLFB) will be used in order to obtain sustained abstinence (v. not) during the past 30 days
Measured: Baseline, 3 months, and 6 months
Change from Baseline Social Anxiety Symptom Severity at 3 and 6 months
The Behavioral Approach Task (BAT), a validated behavioral assessment of social anxiety severity, will be used.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start15 Mar 2018
- Primary completion1 Dec 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Model description
- Eligible participants will be randomized to the Fully Integrated Treatment (FIT; N =30) or usual care in the Matrix Institute IOP (UC; N = 30).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Matrix Institute on Addictions
- Responsible party
- Principal investigator, Kate Taylor, University of California, Los Angeles
- Investigators
- Kate Wolitzky-Taylor, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428490
- Sponsor's protocol ID
- SOCANX1
- Other IDs
- 1R34AA025364-01
- Acronym
- FIT
- Status last verified
- Oct 2022
- First submitted
- 16 Nov 2017
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating a Fully Integrated Treatment Program for Comorbid Social Anxiety and Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT03428490
- Acronym / sponsor ID
- FIT / SOCANX1
- Conditions
- Alcohol Use Disorder, Social Anxiety Disorder
- Keywords
- Integrated Treatment, Alcohol Use Disorder, Social Anxiety Disorder, Comorbidity, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Matrix Institute on Addictions
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 9 Feb 2018 (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.
Alcohol use disorders (AUD) and social anxiety disorder (SAD) are highly comorbid and associated with significant impairment. Social anxiety comorbidity is associated with poorer addiction treatment engagement and outcomes. Thus, addressing underlying SAD symptoms that may lead to and maintain alcohol problems, as well as undermine successful treatment for AUD, is warranted. This proposal aims to develop and evaluate a fully integrated outpatient program for comorbid SAD and AUD that weaves evidence-based treatment for SAD (i.e., exposure-based cognitive behavioral therapy) into a traditional, evidence-based treatment for AUD.
First, the investigators will develop the protocol for the fully integrated treatment (FIT). The overarching goal of FIT will be to simultaneously deliver AUD and SAD treatment. Development will be an iterative process guided by previous research (including our own), and by input from clinicians, administrators, and patients in an outpatient substance use disorder treatment clinic. After the protocol is developed, the investigators will use their established clinician training procedures to train clinicians at their community partnered clinic to competently deliver the intervention. After protocol development and clinician training, the investigators will conduct a pilot randomized clinical trial (RCT) comparing the efficacy of our fully integrated treatment (FIT) for comorbid alcohol use and social anxiety disorders to usual care (UC) in the community substance use disorder specialty clinic. The goals of the RCT will be to gather data regarding acceptability, feasibility, and preliminary efficacy of the FIT protocol. The investigators will randomize treatment-seeking participants (N = 60) who have comorbid SAD and AUD. The investigators will assess treatment engagement, social anxiety outcomes, and alcohol use outcomes at baseline, 3-months, and 6-months from baseline. The investigators will also gather qualitative and quantitative acceptability data from patients after completing FIT, which may guide final refinements of FIT prior to testing in a larger-scale grant.
The knowledge gained from this investigation has the potential to significantly improve the treatment of alcohol use disorders and make a significant public health impact. The focus on direct translation to community practice paradigms and the emphasis on full mental health and addiction treatment integration significantly advance the field.
Detailed description
In this study, potential participants will be screened either by University of California, Los Angeles (UCLA) staff or at the Matrix Institute on Addiction to determine whether they may have social anxiety and alcohol use disorder symptoms. If they screen positive for these symptoms, they will be invited to come in for a comprehensive baseline assessment consisting of interviews, questionnaires, and a behavioral assessment. Eligible participants will be randomly assigned to either receive standard Matrix treatment consisting of a 9-hour per week Intensive Outpatient Program (IOP) lasting approximate 2-3 months; or FIT, an Intensive Outpatient Program (also 9 hours per week for approximately 2-3 months) consisting of cognitive behavioral therapy (CBT) for social anxiety disorder that is woven into the alcohol recovery program. After treatment, participants will complete another assessment, and then will complete one several months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized to the Fully Integrated Treatment (FIT; N =30) or usual care in the Matrix Institute IOP (UC; N = 30).
| Arm | Type | Receives |
|---|---|---|
| Fully Integrated Treatment | Experimental | Behavioral: Fully integrated treatmentEvidence-based substance use treatment combined with Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder Intervention name: Fully integrated treatment |
| Usual Intensive Outpatient Care | Active comparator | Behavioral: Stand-alone Intensive Outpatient ProgramEvidence-based substance use disorder treatment Intervention name: Stand-alone Intensive Outpatient Program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be currently enrolled in the IOP at Matrix Institute (our community partner) for the treatment of their alcohol use disorder;
- fluent in English;
- meet the DSM-5 criteria for social anxiety disorder and alcohol use disorder
Key exclusion criteria (3 listed)
- marked cognitive impairment
- moderate to severe suicidality
- unstable manic or psychotic symptoms.
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 |
|---|---|---|
| Fully integrated treatmentClinicians will be delivering CBT for Social Anxiety Disorder directly into the context of the Matrix's evidence-based treatment for substance use disorders (i.e., The Matrix Model). | Behavioural | Fully Integrated Treatment |
| Stand-alone Intensive Outpatient ProgramEvidence-based treatment for substance use disorders (i.e., The Matrix Model). | Behavioural | Usual Intensive Outpatient Care |
Primary outcome
Change from Baseline Alcohol consumption at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
The Timeline Followback (TLFB), a gold standard semi-structured interview measure of alcohol consumption, will be used in order to obtain number of drinking days
Change from Baseline Social Anxiety Symptoms in Situations at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
The Leibowitz Social Anxiety Scale-Self Report (LSAS-SR) will be used to assess the extent to which individuals are anxious in, and avoid, a variety of social situations, including performance based and social-interactional situations. Anxiety and avoidance are each rated from 1 (none/never) to 4 (extreme/always) Higher scores indicate greater severity of social anxiety.
7 secondary outcomes
Change from Baseline Social anxiety-related drinking motives at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Quality of Life and overall functioning at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Alcohol Problems at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Alcohol Drinks per Day at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Heavy Alcohol Use Days at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Alcohol Abstinence at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Social Anxiety Symptom Severity at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
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 1 Nov 2022.
- 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.
Kate Wolitzky-Taylor, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully integrated treatment and Stand-alone Intensive Outpatient Program in people with Alcohol Use Disorder and Social Anxiety Disorder, run by University of California, Los Angeles 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 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 1 Nov 2022. 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?
Change from Baseline Alcohol consumption at 3 and 6 months (time frame: Baseline, 3 months, and 6 months). 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 1 Nov 2022.