Usefulness of Supportive Text Messages in the Treatment of Depressed Alcoholics

This study has been completed.
Sponsor:
Collaborator:
St Patrick's Hospital, Ireland
Information provided by (Responsible Party):
Vincent Agyapong, University of Dublin, Trinity College
ClinicalTrials.gov Identifier:
NCT01037868
First received: December 22, 2009
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Depression
Alcohol Use Disorder
Other: Supportive SMS text messages

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Trial on the Usefulness of Supportive Text Messages in the Treatment of Depressed Patients With Co-morbid Alcohol Dependency Syndrome

Resource links provided by NLM:


Further study details as provided by University of Dublin, Trinity College:

Primary Outcome Measures:
  • Cumulative abstinence duration which would be measured using the TLFB and collateral reports [ Time Frame: measured at 3 months ] [ Designated as safety issue: No ]
  • Becks Depression Inventory Score [ Time Frame: Measured at 3 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in gamma Glutamyl Transferase (Gamma GT) and Mean Corpuscular Volume (MCV) values from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Global Assessment of Function Score, Obsessive Compulsive Drinking Scale Scores, Alcohol Abstinence Self-Efficacy Scale Score [ Time Frame: Measured at 3 Months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: September 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037868

Locations
Ireland
St Patrick's University Hospital
Dublin, Ireland
Sponsors and Collaborators
University of Dublin, Trinity College
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
  More Information

Additional Information:
Publications:
Brianna S. Fjeldsoe, BA, Alison L. et al , Behaviour Change Interventions Delivered by Mobile Telephone Short-Message Service, Am J Prev Med 2009;36(2):165-173
Patrick K , Raab F, Adams M.A. et al; A Text Message-Based Intervention for Weight Loss: Randomized Controlled Trial, J Med Internet Res 2009;11(1):e1
Bauer S, Percevic R, Okon E, Meermann R, Kordy H. Use of text messaging in the aftercare of patients with bulimia nervosa. Eur Eat Disord Rev. 2003;11:279-290
Pal B. The doctor will text you now; is there a role for the mobile telephone in health care? BMJ 2003;326:607.
R.B. Haynes, D. Sackett, G. Guyatt, P. Tugwell, Clinical Epidemiology: How to do Clinical Practice Research, Lippincott, Williams, Wilkins, Philadelphia, PA, 2005

Responsible Party: Vincent Agyapong, Assistant Professor of Psychiatry, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT01037868     History of Changes
Other Study ID Numbers: UDublinTC
Study First Received: December 22, 2009
Last Updated: March 26, 2013
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University of Dublin, Trinity College:
depression
alcohol dependency syndrome
dual diagnosis
SMS text messages

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Depression
Depressive Disorder
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on August 28, 2014