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

NCT06281821 | Completed

• 1 other identifier: 4947 [Study 2]
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Drinking; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Time Line Follow-Back 30-Day Heavy Episodic Drinking

  past 30 days

• Perceptions of Treatment Questionnaire

  Current perception of intervention assessed 12 weeks following baseline (4 weeks following intervention completion)

• Systems Usability Scale

  Current perception of intervention assessed 12 weeks following baseline (4 weeks following intervention completion)

Study Arms (2)

Mobile App Intervention

EXPERIMENTAL

Mobile health intervention delivered through an app

Behavioral: mhealth-pc

Control

NO INTERVENTION

Assessment Only Control condition

Interventions

mhealth-pc BEHAVIORAL

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.

Mobile App Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• If on medication for pain or alcohol, not on same dose for at least 2 months \[Note: Participants who are on psychoactive medications for pain management may be included if they have a stable (at least 2 months) medication dose and state a willingness to continue use of medication as prescribed by their physician through the intervention phase\]
• Patients with bipolar disorder, schizophrenia, other psychotic disorder, or current suicidal intent.
• Prior history of withdrawal-related seizures or delirium tremens
• Current non-pharmacological treatment for alcohol use disorder or chronic pain.
• Any acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months
• Pain that is related to a current cancer diagnosis
• Patients who are unable to provide one or more individuals who will likely know where they are at follow up
• Individuals who do not have a smartphone with which they can use to complete the remote study procedures.

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Chronic Pain

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor at follow-up timepoint is masked to condition. Baseline assessment occurs prior to randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychological and Brain Sciences

Model Details: Compare an intervention to an assessment only control condition

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: February 6, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)