Text Messaging to Reduce Alcohol Relapse in Liver Transplant 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 scientific
aims of the study are as follows:

1. To develop a mobile, SMS-based stress reduction and alcohol use intervention for pre-
liver transplant patients with alcohol-related liver disease (ALD).

2. 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.

Text messaging is a novel mechanism for intervention in this population. Over the course of
the study, participants randomized to the Text Message condition 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. Because mobile interventions have not been utilized
in studies of alcohol abstinence, the protocol for this text message intervention on past
studies that have used text messages interventions. Specifically, portions of a large-scale
RCT of a text message intervention for smoking cessation and of a smaller study on a text
message intervention for reducing alcohol-related consequences in college students. 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. After the first 4 weeks, they will receive 3 messages per week for the
next 4 weeks. All text messages will be developed with the input of liver transplant
professionals.

All patients will be assessed at 4-weeks and 8-weeks and will provide urine for EtG analysis
to allow biological verification of sobriety. After the 8-week intervention, patients will
complete a satisfaction survey about their experiences in the Text Message condition and
Standard Care condition to assess intervention helpfulness, text message content, and the
ease of using the text message program. These data will allow the examination of the
feasibility and acceptability of the text message intervention.

This study has two phases: (1) Stage 1 - development of intervention text messages and (2)
Stage 2 - pilot randomized controlled trial of Text Message intervention versus Standard
Care.

In Stage 1 - a text message bank of approximately 200-300 text messages will be developed
using empirically supported in-person intervention components for heavy alcohol use and
alcohol dependence. Component areas will be craving, high-risk situations, identification of
alcohol use triggers, stress, mood, quality of life, and coping skills. As text messages will
be used both for assessment and for intervention content, the text message bank will contain
both assessment messages and intervention messages. Following the development of the text
message bank, the messages will be assessed by Consultants to this project, which will
include liver transplantation medical and psychological care providers. Text messages will be
rated on their: (1) readability, (2) acceptability, (3) relevance to patients' concerns, and
(4) helpfulness. Consultants will also be asked to indicate if they think any messages should
be eliminated. Obtaining this feedback prior to the RCT will enhance the Text Message
Intervention's acceptability to liver transplant providers.

Stage 2 is a between-subjects, randomized clinical trial that will compare the effect of a
Text Message intervention with Standard Care in a liver transplantation clinic on alcohol
relapse rate and stress reduction. This trial will also examine the feasibility and efficacy
of the Text Message intervention. A total of 20 subjects, at least 18 years of age, will be
recruited to participate in the trial and will be randomized to receive either the Text
Message intervention or Standard Care. There are three consecutive phases to the study: (1) a
1-week assessment period; (2) an 8- week treatment period; (3) follow-up post-treatment and
at 3-months post-intervention.

In Stage 2, we will conduct a randomized controlled pilot study to test the feasibility,
acceptability, and preliminary efficacy of the final Text Message intervention versus a
Standard Care (SC) intervention. Patients in the SC condition will receive all elements of
their usual care as part of the liver transplant service but will not receive any text
messages.

Screening: Participants who express interest in the study will attend an in-person intake to
learn about the study, provide informed, voluntary consent, be further evaluated for
eligibility and complete baseline assessments for which they will be compensated.
Participants will be randomized to either the Text Message intervention or to SC based on a
preset randomization schedule generated via computer by a statistician. For participants in
the Text Message condition, the RA will demonstrate how to use the text messaging service. A
pre-paid mobile phone will be provided for the duration of the study for all participants.
Study cell phones will have pre-paid text messaging coverage for the duration of the study.

Interventions: In the SC condition, participants will receive only standard care provided by
the liver transplantation team. No additional behavioral or psychosocial interventions will
be provided. 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.

In the Text Message condition, participants will receive daily text messages in addition to
receiving all elements of standard care in the liver transplant service. Daily text messages
will be used to determine their current level of functioning and provide text message
intervention messages in response. Text messages will be sent via Google Voice on a research
computer. A study-specific phone number will be generated via Google and will be the number
from which all participants receive text messages. Participants will receive these messages
on their pre-paid study cell phones only. Participants will be asked to respond to the text
messages either with a specified response (e.g. YES/NO) or with a generic response (e.g.
"1"). This will allow the collection of feasibility data on number of responses to the
messages and verify that participants are reading and receiving the intervention.
Participants' response messages will be received, via Google Voice, on a research computer.
The research assistant will monitor and record whether a participant is responding at least
once per day. As noted, some text messages will ask for a specific reply in response to a
question (e.g. "Any cravings today?"). Based on the participant's response (e.g. "high,"
"med," or "low"), the research assistant will respond with a text message tailored to the
participant's message. Participants will be informed that this account will be used for
research purposes only and should not be used in the case of a clinical emergency, because
all text messages have been pre-generated and it cannot be guaranteed that responses will be
seen at the moment they are sent. All text messages will be sent to the HIC in an amendment
to this protocol for approval.Over the course of the study, 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. Because mobile interventions have not been
utilized in studies of alcohol abstinence, we will base the protocol for this text message
intervention on past studies that have used text message interventions. Specifically, we will
apply portions a large-scale RCT of a text message intervention for smoking cessation and of
a smaller study on a text message intervention for reducing alcohol-related consequences in
college students. Following randomization, participants will receive 2 text messages per day
for the first 4 weeks of the study. Research on the elaboration likelihood model of attitude
change has indicated that tailored messages are more effective than generic messages. Because
intervention messages are most effective if they are tailored to the personal characteristics
of the participant, the daily text messages (content: craving, trigger identification,
high-risk situation identification and other efficacious components of alcohol abstinence
interventions) will be tailored on variables known to be risk factors for pretransplant
abstinence, including gender, family history of alcoholism, and level of social support. 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. After the first 4 weeks, they will receive 3 messages
per week for the next 4 weeks. As noted, these messages will be developed with the input of
liver transplant professionals. As in the Standard Care condition, participants in the Text
Message condition will return to the liver clinic for assessments at 4-weeks and 8-weeks and
to provide urine for EtG analysis.

End of Treatment Monitoring/Follow-Up: After the 8-week intervention, participants will be
contacted via phone to schedule an in-person follow-up appointment. At follow-up participants
will be asked to complete a satisfaction survey about their experiences with the Text Message
or SC interventions. The survey will assess intervention helpfulness, text message content,
and ease of using the text message program and will provide an end-of-treatment urine test.

Inclusion Criteria:

- 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.

Exclusion Criteria:

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