Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study

Chronic Pain Clinical Trial

Official title:

Alcohol Use and Chronic Pain in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281821
• Other study ID #: 4947 [Study 2]
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Boston University Charles River Campus
• Contact: Tibor P Palfai, PhD
• Phone: 617-353-9345
• Email: palfai[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic pain and heavy drinking are common co-occurring conditions among patients presenting to primary care settings. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce alcohol use and pain that can be readily incorporated into the health care settings. The objective of this study is to test a modified version of a smartphone-based intervention for reducing pain and alcohol use among individuals experiencing chronic pain who engage in heavy drinking. The primary goal is to test the feasibility and acceptability of implementing this intervention in a sample that includes participants from rural areas and providing initial data on the utility of the intervention.

Description:

Heavy alcohol use represents a significant risk for morbidity and mortality. Unfortunately, addressing unhealthy patterns of alcohol use is often a challenge as patients typically present to health care settings with co-morbid conditions that: (1) may make unhealthy drinking a lower priority health issue and (2) may impact the capacity for sustained alcohol-related change. Chronic pain is among the most common of these conditions. Pain is a frequent source of distress and disability and is one of the most frequent causes for health care visits. Pain is also an important trigger for alcohol use among patients who drink and is associated with the experience of negative alcohol-related consequences and unhealthy drinking over time. The experience of pain has also been shown to be associated with poorer responses to alcohol interventions. There are a number of challenges when attempting to treat co-occurring unhealthy drinking and pain among their patients. Pain management and reduction of alcohol use among those who engage in heavy alcohol use is often not adequately achieved with pharmacological treatments nor are pharmacological treatments indicated for common pain conditions. Moreover, despite the availability of evidence-based psychosocial interventions for unhealthy drinking and chronic pain, patients with each of these conditions typically show poor adherence to treatment. Given the rates of pain and unhealthy alcohol use and their impact on functioning and medical outcomes, there would be considerable benefit to an accessible, easily utilized, integrative approach to treat heavy alcohol use and pain that can be readily incorporated into health care settings. The objectives of this study are to test the acceptability and feasibility of a smartphone-based intervention for reducing pain and alcohol use among individuals who experience chronic pain and heavy drinking. In addition, the study will provide a preliminary effect size estimates of the intervention on outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• 1 Heavy drinking by NIAAA guidelines (weekly limits [> 7 standard drinks for women or men age 65+, > 14 for men younger than 65], and/or a heavy drinking episode in the past month [>3 for women or men age 65+, > 4 for men younger than 65]) or by a positive USAUDIT-C score

• 2 Chronic pain [at least 3 months in duration] of at least moderate severity (4 or greater on the Numerical Pain Rating Scale from 0-10)

Exclusion Criteria:

• 1 If on medication for pain or alcohol, not on same dose for at least 2 months [Note:

Participants who are on psychoactive medications for pain management may be included if they have a stable (at least 2 months) medication dose and state a willingness to continue use of medication as prescribed by their physician through the intervention phase]

• 2 Patients with bipolar disorder, schizophrenia, other psychotic disorder, or current suicidal intent.

• 3 Prior history of withdrawal-related seizures or delirium tremens

• 4 Current non-pharmacological treatment for alcohol use disorder or chronic pain.

• 5 Any acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months

• 6 Pain that is related to a current cancer diagnosis

• 7 Patients who are unable to provide one or more individuals who will likely know where they are at follow up

• 8 Individuals who do not have a smartphone with which they can use to complete the remote study procedures.

Related Conditions & MeSH terms

• Alcohol Drinking
• Chronic Pain

Intervention

Behavioral:
• mhealth-pc
Participants meet with an interventionist who explains the rationale for the mobile app. They complete video and survey-based intervention content each week for 8 weeks. App-based sessions are supplemented with brief chat-based coaching weekly.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (average weekly), Enjoyment of Life, General Activity (PEG) Scale	Three items with 0-10 scales to assess chronic pain based on the dimensions of pain severity, impact on enjoyment in life, and interference with activity. Range 0-30. Higher scores reflect worse outcomes	7-days
Primary	Time Line Follow-Back-30 Day Weekly Drinking	Average number of drinks per week over the past 30 days. Higher scores reflect worse outcomes.	past 30 days
Secondary	Time Line Follow-Back 30-Day Heavy Episodic Drinking	number of heavy drinking episodes (for men 5 or more on single occasion for women 4+) over tha past 30 days. Higher values reflect worse outcomes	past 30 days
Secondary	Perceptions of Treatment Questionnaire	Ratings of intervention satisfaction using Likert-scale items 0 "not at all" to 8 "very much" to assess degree of perceived help with pain and alcohol use, perceived helpfulness of intervention components. Higher scores reflect better outcomes	Current perception of intervention assessed 12 weeks following baseline (4 weeks following intervention completion)
Secondary	Systems Usability Scale	Three item Likert scale (scored 1 "strongly disagree' to 5 "strongly agree') to assess ease, speed of learning, confidence using the mobile app. Higher scores reflect better outcomes	Current perception of intervention assessed 12 weeks following baseline (4 weeks following intervention completion)