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Single Blind Randomised Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression
Sponsor study identifier
interventional
107
1 country
1
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
March 19, 2015
Actual (reported)March 31, 2015
Actual (reported)March 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Cumulative abstinence duration (CAD).
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.
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.
Proportion of patients continuously abstinent from alcohol at 6 and 12 months.
6 and 12 months post-discharge.
Time to first drink.
3, 6, 9 and 12 months post-discharge.
Perception of patients in the intervention group about the usefulness of supportive text messages.
6 months post-discharge
Changes from baseline in scores on the modified global assessment of function (m-GAF) scale.
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).
This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
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.
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.
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.
St. Patrick's University Hospital
Dublin, Dublin 8, Ireland
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.
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.
Conor Farren, PhD,MRCPsych
St Patrick's Hospital, Ireland
107 participants (actual enrollment reported by the registry).
First Submitted
March 19, 2015
First Posted
March 31, 2015
Study Start
March 2015
Date type not reportedThe 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
This date has not been verified as actual or estimated.
Primary Completion
March 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 5, 2017
Record last verified: 2017-05
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Source: ClinicalTrials.gov.
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