PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain
Primary Purpose
Alcohol Problem, Chronic Pain, Alcohol Abuse
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Feedback Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Problem
Eligibility Criteria
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:
- Concurrent alcohol or other substance use treatment
- Not being fluent in English
- Current acute psychiatric distress or thought disorder
- Current imminent risk of suicidality
Sites / Locations
- University of HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Personalized Feedback Intervention (PFI)
Assessment Only
Arm Description
Personalized Feedback Intervention targeting pain-related anxiety for hazardous drinkers with chronic pain
Assessment only, no active treatment elements
Outcomes
Primary Outcome Measures
Hazardous Drinking
Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking
Hazardous Drinking
Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking
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
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05036499
First Posted
August 6, 2021
Last Updated
October 31, 2022
Sponsor
University of Houston
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05036499
Brief Title
PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain
Official Title
Development of a Personalized Feedback Intervention Targeting Pain-Related Anxiety for Hazardous Drinkers With Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Problem, Chronic Pain, Alcohol Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Personalized Feedback Intervention (PFI)
Arm Type
Experimental
Arm Description
Personalized Feedback Intervention targeting pain-related anxiety for hazardous drinkers with chronic pain
Arm Title
Assessment Only
Arm Type
No Intervention
Arm Description
Assessment only, no active treatment elements
Intervention Type
Behavioral
Intervention Name(s)
Personalized Feedback Intervention
Intervention Description
Providing corrective normative feedback on alcohol use, psychoeducation on the interplay between pain and alcohol use, and providing exercises to target pain-related anxiety
Primary Outcome Measure Information:
Title
Hazardous Drinking
Description
Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking
Time Frame
2 weeks post intervention
Title
Hazardous Drinking
Description
Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking
Time Frame
1 month post intervention
Title
Drinking Quantitiy/Frequency
Description
Timeline Follow Back will be used to assess past 2 week drinking quantity and frequency, and an average alcohol consumption variable will be created
Time Frame
2 weeks post intervention
Title
Drinking Quantitiy/Frequency
Description
Timeline Follow Back will be used to assess past 2 week drinking quantity and frequency, and an average alcohol consumption variable will be created
Time Frame
1 month post intervention
Secondary Outcome Measure Information:
Title
Pain-related Anxiety
Description
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.
Time Frame
Immediately Post intervention
Title
Pain-related Anxiety
Description
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.
Time Frame
2 weeks post intervention
Title
Pain-related Anxiety
Description
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.
Time Frame
1 month post intervention
Title
Motivation to Reduce Drinking
Description
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.
Time Frame
Immediately Post intervention
Title
Motivation to Reduce Drinking
Description
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.
Time Frame
2 weeks post intervention
Title
Motivation to Reduce Drinking
Description
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.
Time Frame
1 month post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Concurrent alcohol or other substance use treatment
Not being fluent in English
Current acute psychiatric distress or thought disorder
Current imminent risk of suicidality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew H Rogers, M.A.
Phone
713-743-8056
Email
ahroger2@central.uh.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael J Zvolensky, Ph.D.
Phone
713-743-8056
Email
mjzvolen@Central.UH.EDU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky, Ph.D.
Organizational Affiliation
University of Houston
Official's Role
Study Chair
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky, Ph.D.
Phone
713-743-8056
Email
houstonahrl@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain
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