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

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ClinicalTrials.gov Identifier: NCT03917875
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Paulus, University of Houston

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.


Condition or disease Intervention/treatment Phase
Alcohol Drinking Anxiety Coping Behavior Behavioral: Personalized feedback intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Computer-Delivered Personalized Feedback Intervention for Hazardous Drinkers With Elevated Anxiety Sensitivity
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Anxiety

Arm Intervention/treatment
No Intervention: Control
Experimental: PFI Behavioral: Personalized feedback intervention
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 Measures :
  1. Motivation for change [ Time Frame: 1 month ]
    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.

  2. Drinks per occasion [ Time Frame: 1 month ]
    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.

  3. Anxiety Sensitivity [ Time Frame: 1 month ]
    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 :
  1. Drinking to cope [ Time Frame: 1 month ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • elevated anxiety sensitivity, hazardous drinking

Exclusion Criteria:

  • current mental health/substance treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917875


Locations
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United States, Texas
University of Houston Recruiting
Houston, Texas, United States
Contact: Daniel Paulus    713-743-8056    djpaulus@uh.edu   
Contact    7137438056    djpaulus@uh.edu   
Sponsors and Collaborators
University of Houston

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Responsible Party: Daniel Paulus, Graduate Student, University of Houston
ClinicalTrials.gov Identifier: NCT03917875     History of Changes
Other Study ID Numbers: STUDY00001045
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Anxiety Disorders
Alcohol Drinking
Mental Disorders
Drinking Behavior