Usefulness of Supportive Text Messages in the Treatment of Depressed Alcoholics

March 26, 2013 updated by: Vincent Agyapong, University of Dublin, Trinity College

A Randomised Trial on the Usefulness of Supportive Text Messages in the Treatment of Depressed Patients With Co-morbid Alcohol Dependency Syndrome

Background:

There is abundant evidence that rates of comorbidity between substance use and depression are high (1, 2) and the risk of poor outcome is higher among individuals with the dual disorder compared with those with a single disorder (3, 4, 5, 6). Previous research has shown that about 50% of persons studied with severe mental illness and past substance abuse are likely to have a recurrence of substance abuse within 1 year of discharge from treatment (7).

There is therefore a clear clinical challenge in treating patients with the dual disorder which may calls for further research and the possible introduction of new and innovative strategies including the use of mobile phone technology to provide increased support for patients with the dual diagnosis.

There are established research evidence for using Short Message Service (SMS) text messages to remind patients of scheduled medical appointments (8,9,10,12, 13), coordinate medical staff,(14) deliver medical test results,(15,16) , promote smoking cessation ( 17), improve self-monitoring among the youth with type 1 diabetes( 18), promote weight loss among obese subjects (19 ) and monitor patient side effects following treatment(20).

Relevance of the research:

To date, after an extensive review of the literature using MEDLINE, Pub Med, ERIC, Web of Science, Science Direct and PsycINFO, no studies was found on the use of SMS text messages as an intervention to address abstinence amongst alcohol dependent subjects who are co-morbid for a depressive disorder. Thus, the investigators seek to determine if text messaging is a useful and effective strategy to help maintain abstinence, improve adherence with medication and ultimately promote mental stability in depressed patients discharged from an in-patient dual diagnosis programme. The investigators hypothesize that, daily supportive/reminder SMS text messages to depressed patients discharged from an in-patient dual diagnosis programme would increase alcohol abstinence rates , improve medication adherence rates and improve the overall mental well being of patients compared with those receiving treatment as usual.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is abundant evidence that rates of comorbidity between substance use and depression are high (1, 2). The risk of poor outcome is higher among individuals with both substance use and mood disorders compared with those that have a single disorder (3, 4, 5, 6). Previous research has shown that about 50% of persons studied with severe mental illness and past substance abuse are likely to have a recurrence of substance abuse within 1 year of discharge from treatment (7). In a study to evaluate the effectiveness of the dual diagnosis treatment programme established in St Patricks' Hospital in Dublin, it was discovered that 71.8% of patients achieved complete abstinence at 3 months and 55.8% at 6 months in the depression group(8).

There is therefore a clear clinical challenge in treating patients with the dual disorder which calls for further research and the introduction of new and innovative strategies capable of improving upon abstinence rates among patients. Such strategies could include the use of mobile phone technology to provide increased support for patients with the dual diagnosis which may translate into increase abstinence rates over time.

Significantly, mobile telephones are becoming integrated into virtually all aspects of society,(9,10,1112) and may provide an opportunity to improve health related behaviours , in particular through the use of Short Message Service (SMS) (13 ). In a randomized controlled trial to evaluate a text message-based intervention designed to help individuals lose or maintain weight over 4 months, the intervention group who received personalized SMS and MMS messages sent two to five times daily, printed materials, and brief monthly phone calls from a health counsellor lost more weight than the comparison group who only received only monthly printed materials (14). In another study, sending text messages to mobile phones increased the effectiveness of a smoking cessation intervention among college students (15). Similarly, in a program conducted among youth with type 1 diabetes (16), daily text messages were helpful for disease self-management, increased self-efficacy, and treatment adherence and achieved high satisfaction among participants. Again, weekly SMS self-monitoring of bulimic symptoms with automatic SMS feedback resulted in good monitoring adherence and acceptability in women aged 16 to 44 post-discharge from inpatient treatment (17). There are also established research evidence for using SMS to remind patients of scheduled medical appointments,(18,19,20,21, 22) coordinate medical staff,(23) deliver medical test results,(24,25,26) and monitor patient side effects following treatment(27).

To date, after an extensive review of the literature using MEDLINE, Pub Med, ERIC, Web of Science, Science Direct and PsycINFO, no studies was found on the use of daily text messages delivered via mobile phone as an intervention to address abstinence amongst alcohol dependent subjects who are co-morbid for a depressive disorder. Thus, we seek to determine if text messaging is a useful and effective strategy to help maintain abstinence, improve adherence with medication and ultimately promote mental stability in depressed patients discharged from an in-patient dual diagnosis programme. We hypothesize that, daily supportive/reminder SMS text messages to depressed patients discharged from an in-patient dual diagnosis programme would increase alcohol abstinence rates , improve medication adherence rates and improve the overall mental well being of patients compared with those receiving treatment as usual. Patients receiving the text messages and phone calls would also report a favourable experience and an overall satisfaction with the system.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • 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
        • 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

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients fulfilling the Diagnostic and Statistical Manual fourth edition(DSM IV) criteria for alcohol dependence and are co-morbid for a unipolar depression and who complete the in-patient dual diagnosis treatment programme.
  • Patients must have an Mini Mental State Examination (MMSE) score of at least 25
  • All patients should have a mobile phone, be familiar with SMS text messaging technology and be willing to take part in the study.

Exclusion Criteria:

  • Patients who do not consent to take part in the study.
  • Patients who are blind, not able to read, do not have a mobile phone or are unable to use the mobile SMS technology.
  • Patients who suffer from dipolar affective disorder.
  • Patients with a history of psychosis or current diagnosis of psychotic disorder
  • Poly-substances dependence or abuse but not misuse.
  • 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive SMS messages
Patients in the intervention group would receive twice daily supportive SMS text messages for 3 months from the treating team which would encourage/motivate them to refrain from drinking alcohol and comply with their medication. They would also receive a fortnightly phone call from an unblinded member of the research/treating team which would only serve the purpose of confirming that they still uses the mobile phone and receive the text messages.
Other: Supportive SMS text messages
Patients in the intervention group would receive twice daily supportive SMS text messages for 3 months from the treating team which would encourage/motivate them to refrain from drinking alcohol and comply with their medication. They would also receive a fortnightly phone call from an unblinded member of the research/treating team which would only serve the purpose of confirming that they still uses the mobile phone and receive the text messages.
No Intervention: No supportive SMS text message
Patients in the non-intervention group would also receive text messages once every fortnight thanking them for participating in the study and a monthly phone call which would only serve the purpose of confirming that they still uses the mobile phone and receive the text messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative abstinence duration which would be measured using the TLFB and collateral reports
Time Frame: measured at 3 months
measured at 3 months
Becks Depression Inventory Score
Time Frame: Measured at 3 Months
Measured at 3 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in gamma Glutamyl Transferase (Gamma GT) and Mean Corpuscular Volume (MCV) values from baseline
Time Frame: 3 months
3 months
Global Assessment of Function Score, Obsessive Compulsive Drinking Scale Scores, Alcohol Abstinence Self-Efficacy Scale Score
Time Frame: Measured at 3 Months
Measured at 3 Months

Collaborators and Investigators

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

Sponsor

University of Dublin, Trinity College

Collaborators

St Patrick's Hospital, Ireland

Investigators

  • Study Chair: Declan McLoughlin, PhD, University of Dudlin Trinity College & St Patricks University Hospital
  • Study Director: Conor Farren, PhD, St Patrick's University Hospital
  • Principal Investigator: Vincent IO Agyapong, MSc MRCPsych, University of Dublin, Trinity College Dublin

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

Helpful Links

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

September 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Estimate)

March 28, 2013

Last Update Submitted That Met QC Criteria

March 26, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDublinTC

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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