PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain

Development of a Personalized Feedback Intervention Targeting Pain-Related Anxiety for Hazardous Drinkers With Chronic Pain

There is a pressing public health need to develop novel interventions that aim to reduce alcohol consumption and concurrent alcohol among hazardous drinkers with comorbid chronic pain. The proposed study will draw upon NIH treatment development guidelines (Stage 1) to translate and innovate past work to address a major public health priority. Specifically, we propose to develop (Phase IA) and pilot test (Phase IB) a brief, integrated, single-session, computer-based personalized feedback intervention (PFI) designed to 1) enhance knowledge regarding adverse pain-related anxiety-alcohol interrelations; and (2) increase motivation and intention to reduce hazardous drinking.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Alcohol Abuse; Alcohol Problem
• Intervention / Treatment: Behavioral: Personalized Feedback Intervention

Detailed Description

Hazardous alcohol use contributes to mental and physical health problems, disability, and may lead to increased risk of premature death. Among individuals with chronic pain the rate of hazardous alcohol use is elevated compared to the general population, yet, hazardous alcohol users with chronic pain remain an underserved group. There is a critical need to test alternative and complimentary approaches to the implementation of effective interventions to reduce hazardous alcohol use among this high-risk segment of the general population; doing so in an integrated fashion (i.e., jointly targeting alcohol and affective mechanisms that may maintain pain-alcohol associations) may provide a more efficient and targeted intervention approach. Targeting pain-related anxiety, a transdiagnostic vulnerability factor that is prospectively associated with both hazardous drinking and chronic pain, may be beneficial. Thus, more work is needed to evaluate the benefit of targeting elevated pain-related anxiety among hazardous drinkers with chronic pain. Our approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral interventions. Phase IB activities will include a proof-of-concept and highly rigorous randomized clinical trial designed to compare pain-related anxiety/alcohol PFI (PA-PFI) to assessment only among a sample of 130 hazardous drinkers with chronic pain who have elevated levels of pain-related anxiety. This study represents an important and pivotal step in the larger landscape of translating basic research to more efficacious strategies for reducing hazardous drinking among underserved populations with medical comorbidities. The proposed intervention would be highly disseminable and relevant to millions of hazardous drinkers with chronic pain. Given the collective public health impact of chronic pain and hazardous drinking, the proposed study will yield findings that enhance scientific knowledge, enhance our understanding of mechanisms in reciprocal pain-alcohol relations, and inform the development of novel treatments for hazardous drinkers with chronic pain with elevated pain-related anxiety that are adaptable and easily implemented across a variety of healthcare settings.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew H Rogers, M.A.; Phone Number: 713-743-8056; Email: ahroger2@central.uh.edu
• Study Contact Backup: Name: Michael J Zvolensky, Ph.D.; Phone Number: 713-743-8056; Email: mjzvolen@Central.UH.EDU

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 21 years of age
• Current hazardous drinking pattern (AUDIT scores ≥ 8 for males and ≥ 7 for females)
• Current chronic pain (1) on most days of the week (i.e., 4 or more days per week), (2) at an average weekly severity of 3 or greater on a 0-10 numerical rating scale, and (3) for at least three months in duration
• Fluent in English

Exclusion Criteria:

1. Concurrent alcohol or other substance use treatment
2. Not being fluent in English
3. Current acute psychiatric distress or thought disorder
4. Current imminent risk of suicidality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized Feedback Intervention (PFI); Personalized Feedback Intervention targeting pain-related anxiety for hazardous drinkers with chronic pain	Behavioral: Personalized Feedback Intervention; Providing corrective normative feedback on alcohol use, psychoeducation on the interplay between pain and alcohol use, and providing exercises to target pain-related anxiety
No Intervention: Assessment Only; Assessment only, no active treatment elements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hazardous Drinking	Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking	2 weeks post intervention
Hazardous Drinking	Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking	1 month post intervention
Drinking Quantitiy/Frequency	Timeline Follow Back will be used to assess past 2 week drinking quantity and frequency, and an average alcohol consumption variable will be created	2 weeks post intervention
Drinking Quantitiy/Frequency	Timeline Follow Back will be used to assess past 2 week drinking quantity and frequency, and an average alcohol consumption variable will be created	1 month post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain-related Anxiety	A measure of anxiety related to pain (pain anxiety symptoms scale 20) and pain-elicitnig activities. Range of scores from 0-100, with higher scores indicating greater fear and anxiety.	Immediately Post intervention
Pain-related Anxiety	A measure of anxiety related to pain (pain anxiety symptoms scale 20) and pain-elicitnig activities. Range of scores from 0-100, with higher scores indicating greater fear and anxiety.	2 weeks post intervention
Pain-related Anxiety	A measure of anxiety related to pain (pain anxiety symptoms scale 20) and pain-elicitnig activities. Range of scores from 0-100, with higher scores indicating greater fear and anxiety.	1 month post intervention
Motivation to Reduce Drinking	The Alcohol Ladder will be used to assess motivation to reduce drinking on a 0-10 scale, with 0 indicating no motivation to reduce drinking, and 10 indicating 100% intend to reduce drinking.	Immediately Post intervention
Motivation to Reduce Drinking	The Alcohol Ladder will be used to assess motivation to reduce drinking on a 0-10 scale, with 0 indicating no motivation to reduce drinking, and 10 indicating 100% intend to reduce drinking.	2 weeks post intervention
Motivation to Reduce Drinking	The Alcohol Ladder will be used to assess motivation to reduce drinking on a 0-10 scale, with 0 indicating no motivation to reduce drinking, and 10 indicating 100% intend to reduce drinking.	1 month post intervention

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Study Chair: Michael J Zvolensky, Ph.D., University of Houston

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Alcoholism; Chronic Pain; Alcohol-Related Disorders
• Other Study ID Numbers: F31AA028694 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No