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

NCT ID: NCT03917875

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2019-12-31

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.

Conditions

Alcohol Drinking; Anxiety; Coping Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

PFI

Group Type: EXPERIMENTAL

Personalized feedback intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• elevated anxiety sensitivity, hazardous drinking

Exclusion Criteria

• current mental health/substance treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Daniel Paulus

Graduate Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

STUDY00001045

Identifier Type: -

Identifier Source: org_study_id