The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis

Conditions

• Cirrhoses, Liver

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• High-touch self-management program — BEHAVIORAL
  Tailored digital self-management program, individualized pain coaching, and a structured walking or meditation curriculum selected through Active Choice as the primary behavioral focus for 48 weeks. On-demand coaching for low-pain self-efficacy and optional group coaching sessions.
• Low-touch self-management program — BEHAVIORAL
  Access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.

Study Details

The goal of this clinical trial is to test a low-touch vs high-touch drug-free pain self-management program that may help lower pain and improve quality of life for adults with cirrhosis and pain. Participants are assigned by chance to one of two study groups. The groups receive different levels of support. The main questions it aims to answer are: * Do the programs help lower pain? * Do the programs improve quality of life? * Is one program more effective than the other? Researchers will compare a low-touch self management program to a high-touch self-management program to see if the programs help manage pain. Participants in the low-touch arm will: * Learn new ways to manage pain without medication * Receive access to the self-guided digital self-management platform * Receive general behavioral text message nudges * Receive a free Fitbit to keep Participants in the high-touch arm will: * Learn new ways to manage pain without medication * Receive tailored access to the self-guided digital self-management platform * Received individualized pain coaching and optional group coaching sessions * Participate in a structured walking or meditation curriculum * Receive a free Fitbit to keep

Key Dates

First listed

Aug 28, 2026

Start date

Jan 1, 2027

Status verified

Aug 2026

Primary completion

Mar 1, 2030

Completion

Jun 1, 2030

Study Design

Enrollment

625 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: High-Touch
  Participants receive tailored digital self-management program, individualized pain coaching, and a structured walking or meditation curriculum selected through Active Choice as the primary behavioral focus for 48 weeks. The high-touch arm also includes on-demand coaching for low-pain self-efficacy and optional group coaching sessions.
• Experimental: Low-Touch
  Participants receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.

Primary Outcome Measure

Pain Interference [ Time Frame: 48 weeks ]

Locations (8)

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