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

NCT ID: NCT02404662

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dual Diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Supportive text messages intervention

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Dublin, Trinity College

OTHER

Sponsor Role collaborator

St Patrick's Hospital, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Dr. Conor Farren

Associate Clinical Professor, Trinity College Dublin; Consultant Psychiatrist, St Patrick's University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Conor Farren, PhD,MRCPsych

Role: PRINCIPAL_INVESTIGATOR

St Patrick's Hospital, Ireland

Locations

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St. Patrick's University Hospital

Dublin, , Ireland

Site Status

Countries

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Ireland

References

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Agyapong VI, Ahern S, McLoughlin DM, Farren CK. Supportive text messaging for depression and comorbid alcohol use disorder: single-blind randomised trial. J Affect Disord. 2012 Dec 10;141(2-3):168-76. doi: 10.1016/j.jad.2012.02.040. Epub 2012 Mar 29.

Reference Type BACKGROUND
PMID: 22464008 (View on PubMed)

Agyapong VI, McLoughlin DM, Farren CK. Six-months outcomes of a randomised trial of supportive text messaging for depression and comorbid alcohol use disorder. J Affect Disord. 2013 Oct;151(1):100-4. doi: 10.1016/j.jad.2013.05.058. Epub 2013 Jun 22.

Reference Type BACKGROUND
PMID: 23800443 (View on PubMed)

Agyapong VI, Milnes J, McLoughlin DM, Farren CK. Perception of patients with alcohol use disorder and comorbid depression about the usefulness of supportive text messages. Technol Health Care. 2013;21(1):31-9. doi: 10.3233/THC-120707.

Reference Type BACKGROUND
PMID: 23358057 (View on PubMed)

Hartnett D, Murphy E, Kehoe E, Agyapong V, McLoughlin DM, Farren C. Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial. BMJ Open. 2017 May 29;7(5):e013587. doi: 10.1136/bmjopen-2016-013587.

Reference Type DERIVED
PMID: 28554910 (View on PubMed)

Other Identifiers

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HRA-POR-2014-598

Identifier Type: -

Identifier Source: org_study_id