Text Messaging to Reduce Alcohol Relapse in Liver Transplant Patients

NCT03402256 | Completed

• 1 other identifier: 1210011022
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study of a text-messaging intervention to reduce alcohol relapse risk in pre-transplant liver transplantation patients. This study is an 8-week, randomized controlled pilot trial to investigate the feasibility and acceptability of a text-messaging intervention for alcohol relapse prevention and stress reduction in 20 liver transplant patients with alcohol-related liver disease. The goals of the study are (1) to develop a mobile, SMS-based stress reduction and alcohol use intervention for pre- liver transplant patients with alcohol-related liver disease (ALD) and (2) to evaluate the feasibility and acceptability of the mobile intervention and its effect on rates of alcohol consumption compared to a Standard Care condition in a liver transplantation center.

Conditions

Alcoholic Liver Disease

Keywords

Mobile Technology; Alcohol; Alcoholic Liver Disease; Ethyl Glucuronide

Outcome Measures

Primary Outcomes (2)

• Intervention Feasibility Evaluation

  Patterns of text message usage

  8 weeks

• Alcohol Abstinence Rates

  Biologically confirmed (EtG) rates of abstinence from alcohol

  8 Weeks

Secondary Outcomes (2)

• Subjective Alcohol Abstinence Rates

  8 Weeks

• Stress Ratings

  8 Weeks

Study Arms (2)

Text Message (TM)

EXPERIMENTAL

Participants will receive daily text messages and all elements of standard care. They received 3 text messages per day for the first four weeks of the study and 3 messages per week for the last four weeks. Key domains of message topics were chosen based on the content of evidence-based, relapse prevention treatment. Daily messages determined current level of functioning and provide intervention messages in response. Text messages will be sent via Google Voice on a research computer. Participants will respond to the text messages either with a specified response (e.g. YES/NO) or a generic response (e.g. "1"). Some messages will ask for a specific reply in response to a question. Based on the participant's response (e.g. "high," "med," "low"), the research assistant will respond with a text message tailored to the participant's message. All text messages will be sent to the HIC in an amendment to this protocol for approval.

Behavioral: Text Message

Standard Care (SC)

NO INTERVENTION

Participants will receive only standard care provided by the liver transplantation team. No additional behavioral or psychosocial interventions will be provided. All aspects of care received by SC participants will also provided to the TM condition participants. Medical care will be managed by medical specialty providers. SC condition participants will receive behavioral treatment within the liver transplantation clinic by psychology fellows and/or psychologists/psychiatrists. Treatment schedules and session topics will be determined by individual providers, per usual practice. These participants will receive only study-specific assessments. Participants in this condition will complete assessments at baseline, 4-weeks and 8-weeks that measure self- reported substance use, stress, and coping skills. At each in-person assessment, participants will provide urine for EtG analysis and will be compensated.

Interventions

Text Message BEHAVIORAL

In addition to the SC interventions, participants in the Text Message condition received text messages. Participants received 3 text messages per day for the first four weeks of the study and 3 messages per week for the last four weeks. Participants will receive messages targeting known predictors of alcohol abstinence and relapse, including (1) craving, (2) identification of high-risk situations, (3) identification of triggers, (4) stress level, (5) coping skills, and (5) quality of life. The text messages will include motivational messages and behavior-change techniques (e.g. coping with cravings and urges to drink, trigger identification, high-risk situation identification). Messages will encourage participants to continue with sobriety and focus on the success they have achieved so far.

Also known as: Mobile Intervention

Text Message (TM)

Eligibility Criteria

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

You may qualify if:

• at least 18 years of age;
• diagnosis of alcohol-related liver disease;
• currently in evaluation for UNOS listing as a liver transplant candidate;
• last reported use of any alcohol within the past 1 year;
• willingness to receive and respond to multiple text messages per day.

You may not qualify if:

• unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, or dementia.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Transplantation Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (5)

• Free C, Knight R, Robertson S, Whittaker R, Edwards P, Zhou W, Rodgers A, Cairns J, Kenward MG, Roberts I. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. Lancet. 2011 Jul 2;378(9785):49-55. doi: 10.1016/S0140-6736(11)60701-0.

  PMID: 21722952 BACKGROUND

• Weitzel JA, Bernhardt JM, Usdan S, Mays D, Glanz K. Using wireless handheld computers and tailored text messaging to reduce negative consequences of drinking alcohol. J Stud Alcohol Drugs. 2007 Jul;68(4):534-7. doi: 10.15288/jsad.2007.68.534.

  PMID: 17568957 BACKGROUND

• Webb MS, Hendricks PS, Brandon TH. Expectancy priming of smoking cessation messages enhances the placebo effect of tailored interventions. Health Psychol. 2007 Sep;26(5):598-609. doi: 10.1037/0278-6133.26.5.598.

  PMID: 17845111 BACKGROUND

• Pfitzmann R, Schwenzer J, Rayes N, Seehofer D, Neuhaus R, Nussler NC. Long-term survival and predictors of relapse after orthotopic liver transplantation for alcoholic liver disease. Liver Transpl. 2007 Feb;13(2):197-205. doi: 10.1002/lt.20934.

  PMID: 17205563 BACKGROUND

• Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28.

  PMID: 19646331 BACKGROUND

MeSH Terms

Conditions

Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Benjamin Toll, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Kelly S DeMartini, PhD

  Yale Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: All clinical members of the liver transplantation service will be blind to the results of self-report data collected during the study and to urine toxicology results. The PI and Co-I, who also serves as the Project Manager, will not be blind to participant condition. The Research Assistant will not be blind to the participant condition after delivery of the study-provided cell phone to participants randomized to the Text Message condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either the Text Message intervention or to Standard Care based on a preset randomization schedule generated via computer by a statistician.

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: January 18, 2018
• Study Start: March 22, 2013
• Primary Completion: March 25, 2014
• Study Completion: May 6, 2014
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)