Clinical trial NCT05036499: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Problem
Chronic Pain
Alcohol Abuse
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-09-05
Enrollment: 117
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Hazardous Drinking
timeFrame: 2 weeks post intervention
measure: Hazardous Drinking
timeFrame: 1 month post intervention
measure: Drinking Quantitiy/Frequency
timeFrame: 2 weeks post intervention
measure: Drinking Quantitiy/Frequency
timeFrame: 1 month post intervention
Secondary outcomes:
measure: Pain-related Anxiety
timeFrame: Immediately Post intervention
measure: Pain-related Anxiety
timeFrame: 2 weeks post intervention
measure: Pain-related Anxiety
timeFrame: 1 month post intervention
measure: Motivation to Reduce Drinking
timeFrame: Immediately Post intervention
measure: Motivation to Reduce Drinking
timeFrame: 2 weeks post intervention
measure: Motivation to Reduce Drinking
timeFrame: 1 month post intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Michael J Zvolensky, Ph.D.
role: STUDY_CHAIR
References: