An interventional study of Personalized Feedback Intervention in Alcohol Problem, Chronic Pain and Alcohol Abuse, sponsored by University of Houston. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by University of Houston · Not applicable, Interventional, and Treatment
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.
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.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 117 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
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Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
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Exclusion Criteria:
Personalized Feedback Intervention targeting pain-related anxiety for hazardous drinkers with chronic pain
Behavioral: Personalized Feedback Intervention
Assessment only, no active treatment elements
Providing corrective normative feedback on alcohol use, psychoeducation on the interplay between pain and alcohol use, and providing exercises to target pain-related anxiety
Hazardous Drinking
Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking
Time frame: 2 weeks post intervention
Hazardous Drinking
Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking
Time frame: 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
Time frame: 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
Time frame: 1 month 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month post intervention
Plan to share: No
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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