Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression

October 4, 2017 updated by: Dr. Conor Farren, St Patrick's Hospital, Ireland

Single Blind Randomised Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression

Most patients who present with problem drinking also present with mood problems. Problem drinking and mood problems co-occurring together in individuals lead them to have more severe symptoms, greater disability and poorer quality of life than individuals with only problem drinking, and they pose a greater economic burden to society due to their higher use of health services. This study aims to assess the efficacy of a new, innovative and cost effective treatment strategy aimed at reducing the burden that these co-occurring conditions impose on the suffers and their families as well as the community and health systems.

In a recent pilot study of supportive text messages for patients with problem drinking and co-occurring depression, the investigators established that patients who received twice daily supportive text messages for three months had significantly less depressive symptoms than those who did not receive such messages. There was also a trend to finding that patients who received the supportive text messages were more likely to have higher alcohol free days than those who did not receive any supportive text messages.

This study seeks to extend the knowledge gained from the pilot study. A larger group of patients with alcohol use disorder and a depressive disorder will be randomly assigned to two groups. One group will receive supportive text messages for six months duration whilst the other group will receive no supportive text messages. The patients will be followed up at 3, 6, 9 and 12 months to determine which of the two groups have less alcohol and mood problems. It is anticipated that patients receiving supportive text messages will report significantly greater alcohol free days as well as significantly less relapses, hospitalizations and mood symptoms than those not receiving such messages.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Co-morbidity of alcohol use disorder (AUD) and mood disorders presents a great challenge to health systems and exacts a tremendous toll world-wide. Individuals with a dual diagnosis have more severe symptoms, greater disability and poor quality of life than those with either diagnosis alone, and pose a greater economic burden to society due to their higher use of treatment services. New, enhanced, efficient, innovative and cost effective treatment strategies aimed at reducing the burden that the disorders impose on the suffers and their families as well as the community and health systems are required. In a pilot trial of supportive text messages for patients with alcohol use disorders and co-morbid depression, the investigators established that patients who received twice daily supportive text messages for three months had significantly less depressive symptoms than those who did not receive such messages. There was also a trend to finding that patients who received the supportive text messages were more likely to have higher cumulative abstinence duration than those who did not receive any supportive text messages.

This research seeks to extend the knowledge gained from the pilot trial. A randomised trial will be conducted on a larger sample size of patients with alcohol use disorder and a co-morbid depressive disorder (including bipolar depression) for an extended duration (6 months of supportive text messages and 1 year follow-up instead of 3 months text messages with 6 months follow-up in the pilot trial). It is hypothesised that patients receiving supportive text messages will report significantly greater cumulative abstinence duration as well as significantly less relapses, hospitalizations and mood symptoms than those not receiving such messages. It is anticipated that this technology intervention for relapse prevention will be acceptable to patients as well as cost effective.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, Dublin 8
        • St. Patrick's University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who meet the criteria for both alcohol dependency syndrome/alcohol abuse and either major depressive disorder or bipolar disorder according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) and are enrolled on the in-patient dual diagnosis or addiction treatment programmes in St. Patrick's University Hospital.
  2. Able to provide written, informed consent.
  3. Mini-mental state examination (MMSE) score of ≥ 25
  4. Patients who have a mobile phone, are familiar with SMS text messaging technology and are willing to take part in the study.

Exclusion Criteria:

  1. Patients who do not consent to take part in the study.
  2. Patients who do not have a mobile phone or are unable to use the mobile text message technology.
  3. Patients who would be unavailable for follow-up during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Supportive text messages intervention
Patients in the intervention group will receive twice daily supportive text messages to their mobile phone for 6 months following discharge from a 4-week in-patient dual diagnosis treatment programme. The messages will be sent by a computer programme at 10am and 7pm each day and will be set up and monitored by the research worker who will not participate in follow-up assessments. They will receive a fortnightly text message thanking them for participating in the study, and a brief phone call every 2 weeks to ensure that they are still using their phone and that they have received some messages. The intervention group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings.
Other: Supportive text messages intervention
The supportive text messages are based on existing aphorisms in the recovery literature. Each day patients will receive one message targeting mood and another message targeting abstinence from alcohol in accordance with the primary aims of our study. An example text message aimed at improving mood is: "Monitor changes in your mood; develop a list of personal warning signs." An example message targeting abstinence is: "Keep Sobriety as a number one priority and you will reach your goals. None of the messages will be repeated. The messages will be sent in the morning and evening, with the theme (mood/alcohol) of the messages pseudo-randomised according to delivery time, so that no more than three successive days will have the same theme sent at the same time slot.
Active Comparator: Control group
Patients in the control group will receive a fortnightly text message thanking them for participating in the study, and a brief phone call every 2 weeks to ensure that they are still using their phone and that they have received some messages. The control group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings.
Other: Control group
The control group will receive treatment as usual, as well as fortnightly thank you text messages and calls to ensure that they are still using their phone.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cumulative abstinence duration (CAD).
Time Frame: 12 months following discharge from the inpatient treatment programme.
CAD will be assessed using the timeline to follow-back (TLFB). This will be used to record the quantity of alcohol consumed and number of drinking days.
12 months following discharge from the inpatient treatment programme.
Changes in Beck's Depression Inventory (BDI) scores from baseline.
Time Frame: BDI will be administered at baseline (during the in-patient treatment programme for dual diagnosis), and then at 3, 6, 9 and 12 months post-discharge from hospital.
The BDI is a self-administered questionnaire widely used to assess depressive symptoms. It takes approximately 5 minutes to complete.
BDI will be administered at baseline (during the in-patient treatment programme for dual diagnosis), and then at 3, 6, 9 and 12 months post-discharge from hospital.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients continuously abstinent from alcohol at 6 and 12 months.
Time Frame: 6 and 12 months post-discharge.
Continuous abstinence will be assessed using the TLFB.
6 and 12 months post-discharge.
Time to first drink.
Time Frame: 3, 6, 9 and 12 months post-discharge.
The time between the patient's discharge from hospital and their first drink, if any, during the study, will be measured using the TLFB.
3, 6, 9 and 12 months post-discharge.
Perception of patients in the intervention group about the usefulness of supportive text messages.
Time Frame: 6 months post-discharge
Patient perceptions about the usefulness of the intervention will be assessed at the end of the intervention period in an interview.
6 months post-discharge
Changes from baseline in scores on the modified global assessment of function (m-GAF) scale.
Time Frame: This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
The m-GAF will be used to measure subjective changes in the social, occupational and psychological functioning of the patients over the course of the study.
This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the alcohol expectancy questionnaire (AEQ).
Time Frame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
This scale will measure changes in attitudes towards alcohol over the course of the study.
This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the obsessive compulsive drinking scale (OCDS).
Time Frame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
This scale will measure changes in obsessive compulsive thoughts about alcohol over the 12 months of the study.
This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the alcohol abstinence self-efficacy scale (AASES).
Time Frame: These scales will be administered at baseline and then at 3, 6, 9 and 12 months.
This scale will measure changes in feelings of self-efficacy and personal control around drinking over the 12 months of the study.
These scales will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the perceived stress scale (PSS).
Time Frame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
This scale will measure changes in perceived stress over the 12 months of the study. This construct is closely related to resilience, which is a positive predictor of recovery in addiction.
This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the young mania rating scale (YMRS).
Time Frame: This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
This subjective rating scale assesses the level of mania in patients with bipolar disorder (BP). It will be used to track changes in the manic symptoms of the BP patients over the 12 months of the study.
This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in blood measures of alcohol abuse.
Time Frame: Blood samples will be analysed at baseline, then at 3, 6, 9 and 12 months following discharge.
Three blood measures suggestive of alcohol abuse will be taken to corroborate self-report measures of alcohol intake or abstinence from the TLFB- gamma glutamyl transferase (GGT), alkaline phosphatase (AST) and mean corpuscular volume (MCV).
Blood samples will be analysed at baseline, then at 3, 6, 9 and 12 months following discharge.
Patient satisfaction with overall treatment protocol in both groups
Time Frame: 3, 6, 9 and 12 months
Patient satisfaction will be assessed using an adaptation of a treatment evaluation questionnaire.
3, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St Patrick's Hospital, Ireland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Dublin, Trinity College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Conor Farren, PhD,MRCPsych, St Patrick's Hospital, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRA-POR-2014-598

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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