Computer-Delivered PFI for Anxiety Sensitivity/Alcohol Intervention for Hazardous Drinkers With Elevated Anxiety Sensitivity

Study Overview
=================
Brief Summary
-----------------
Hazardous alcohol consumption is one of the leading causes of preventable deaths in the United States. Further, it is highly comorbid with anxiety and depressive symptoms and disorders; hazardous alcohol use is associated with increased anxiety/depression. Indeed, 'affectively-vulnerable hazardous drinkers' (i.e., drinkers with elevated negative mood states or psychopathology) are 'at risk' for higher drinking rates, more problematic drinking, worsened mental health, and greater disability. Specialty care options are needed to address the unique 'affective needs' of hazardous drinkers. One promising intervention approach is to employ personalized feedback interventions (PFI). These interventions are brief, efficient, and have been shown to be effective in a number of settings and across an array of populations. However, PFIs have not been evaluated among affectively vulnerable hazardous drinkers. In order to address the heterogeneity of negative mood states and disorders among hazardous drinkers, there is a need to theoretically orient the intervention approach on underlying transdiagnostic processes that underpin affective psychopathology. Anxiety sensitivity (AS), the tendency to fear anxiety-related sensations, is a core transdiagnostic vulnerability factor underlying the etiology and maintenance of anxiety disorders, other emotional disorders, and hazardous drinking. AS is malleable in response to psychosocial interventions, making it a prime risk factor to target in prevention/intervention programs, including PFI approaches. Integrated treatments that address hazardous drinking via AS are nonexistant. As most hazardous drinkers typically do not access treatment because of such barriers as cost, time commitments, stigma, and logistics (e.g., travel, scheduling appointments), there is a need to develop an accessible, brief, integrated tool to explicitly address the drinking-affective vulnerability comorbidity via AS. To address this public health gap, the current proposal seeks to employ a computer-delivered integrated PFI that directly addresses hazardous drinking-AS in a personalized manner. Hazardous drinkers with elevated AS will be randomly assigned to receive one session of PFI or attention information control with follow-up assessments at one week and one month post-intervention. The PFI will focus on targeted feedback about drinking behaviors, AS, and adaptive coping strategies.

Official Title
-----------------
Computer-Delivered Personalized Feedback Intervention for Hazardous Drinkers With Elevated Anxiety Sensitivity

Conditions
-----------------
Alcohol Drinking, Anxiety, Coping Behavior

Intervention / Treatment
-----------------
* Behavioral: Personalized feedback intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elevated anxiety sensitivity, hazardous drinking Exclusion Criteria: current mental health/substance treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: PFI<br> | Behavioral: Personalized feedback intervention<br>* The novel integrated PFI will be developed and modeled from past PFIs targeting hazardous drinking. Participants will view feedback on the computer screen. The computer program/algorithm will determine the proper normative feedback to participants.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation for change | The Alcohol Ladder (Clair et al., 2011). The Alcohol Ladder is a reliable and valid (Hogue, Dauber, & Morgenstern, 2010) measure of motivation to change alcohol use. It contains 10 statements that correspond to stages of change: pre-contemplation (e.g., I enjoy drinking and have decided I'll never change it. I have no interest in changing the way I drink), contemplation (e.g., I rarely think about changing the way I drink, and I have no plans to change it), preparation (e.g., I definitely plan to change my alcohol use, and I'm almost ready to make some plans about how to change), action (e.g., I have changed my drinking, but I still worry about slipping back. So I need to keep working on the changes I've made), and maintenance (e.g., I have changed my drinking and will never go back to the way I drank before). Participants select the statement that best corresponds to their current stage of motivation regarding changes in their alcohol use. | 1 month | 
| Drinks per occasion | Drinks per occasion will be assessed as a ratio of the number of drinks consumed in the past 30 days over the number of drinking occasions reported over the past 30 days. | 1 month | 
| Anxiety Sensitivity | Anxiety Sensitivity sensitivity will be assessed with the Anxiety Sensitivity Index-3 (ASI-3; Taylor et al., 2007). The ASI-3 is an 18-item self-report measure of anxiety sensitivity. Items (e.g., It scares me when my heart beats rapidly) are rated on a 5-point Likert-type scale from 0 (very little) to 4 (very much). Items are summed to a total score. The ASI-3 shows good convergent and discriminant validity (Taylor et al., 2007). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinking to cope | Drinking to cope will be measured with the Drinking motives questionnaire-revised (DMQ-R; Cooper, 1994). The DMQ-R is a 20-item self-report measure of drinking motives. It contains four subscales: social, enhancement, social pressure/conformity, and coping with anxiety/depression. The coping subscale (e.g., to forget your worries) will serve as the measure of drinking to cope with emotional symptoms. | 1 month |