search
Back to results

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

Primary Purpose

Alcohol Drinking, Anxiety, Coping Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized feedback intervention
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • elevated anxiety sensitivity, hazardous drinking

Exclusion Criteria:

  • current mental health/substance treatment

Sites / Locations

  • University of Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

PFI

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

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.

Full Information

First Posted
April 5, 2019
Last Updated
February 21, 2020
Sponsor
University of Houston
search

1. Study Identification

Unique Protocol Identification Number
NCT03917875
Brief Title
Computer-Delivered PFI for Anxiety Sensitivity/Alcohol Intervention for Hazardous Drinkers With Elevated Anxiety Sensitivity
Official Title
Computer-Delivered Personalized Feedback Intervention for Hazardous Drinkers With Elevated Anxiety Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Anxiety, Coping Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
PFI
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Personalized feedback intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motivation for change
Description
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.
Time Frame
1 month
Title
Drinks per occasion
Description
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.
Time Frame
1 month
Title
Anxiety Sensitivity
Description
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).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Drinking to cope
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: elevated anxiety sensitivity, hazardous drinking Exclusion Criteria: current mental health/substance treatment
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs