Chronic Pain Clinical Trial
Official title:
Development of a Personalized Feedback Intervention Targeting Pain-Related Anxiety for Hazardous Drinkers With Chronic Pain
Verified date | December 2023 |
Source | University of Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 117 |
Est. completion date | March 15, 2023 |
Est. primary completion date | March 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Houston | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hazardous Drinking | Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking | 2 weeks post intervention | |
Primary | Hazardous Drinking | Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking | 1 month post intervention | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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