Usefulness of Supportive Text Messages in the Treatment of Depressed Alcoholics

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037868
• Other study ID #: UDublinTC
• Status: Completed
• Phase: N/A
• First received: December 22, 2009
• Last updated: March 26, 2013
• Start date: September 2009
• Est. completion date: January 2012

Study information

• Verified date: March 2013
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Depression

Intervention

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.

Locations

Country	Name	City	State
Ireland	St Patrick's University Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	St Patrick's Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (27)

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

Bos A, Hoogstraten J, Prahl-Andersen B. Failed appointments in an orthodontic clinic. Am J Orthod Dentofacial Orthop. 2005 Mar;127(3):355-7. — View Citation

Brady KT, Sonne SC. The relationship between substance abuse and bipolar disorder. J Clin Psychiatry. 1995;56 Suppl 3:19-24. Review. — View Citation

Brown RA, Monti PM, Myers MG, Martin RA, Rivinus T, Dubreuil ME, Rohsenow DJ. Depression among cocaine abusers in treatment: relation to cocaine and alcohol use and treatment outcome. Am J Psychiatry. 1998 Feb;155(2):220-5. — View Citation

Cocosila M, Archer N, Haynes RB, Yuan Y. Can wireless text messaging improve adherence to preventive activities? Results of a randomised controlled trial. Int J Med Inform. 2009 Apr;78(4):230-8. doi: 10.1016/j.ijmedinf.2008.07.011. Epub 2008 Sep 7. — View Citation

Cohen CE, Coyne KM, Mandalia S, Waters AM, Sullivan AK. Time to use text reminders in genitourinary medicine clinics. Int J STD AIDS. 2008 Jan;19(1):12-3. doi: 10.1258/ijsa.2007.007149. — View Citation

Dixon L, McNary S, Lehman AF. Remission of substance use disorder among psychiatric inpatients with mental illness. Am J Psychiatry. 1998 Feb;155(2):239-43. — View Citation

Downer SR, Meara JG, Da Costa AC. Use of SMS text messaging to improve outpatient attendance. Med J Aust. 2005 Oct 3;183(7):366-8. — View Citation

Farren CK, Mc Elroy S. Treatment response of bipolar and unipolar alcoholics to an inpatient dual diagnosis program. J Affect Disord. 2008 Mar;106(3):265-72. Epub 2007 Aug 16. — View Citation

Feinman JA, Dunner DL. The effect of alcohol and substance abuse on the course of bipolar affective disorder. J Affect Disord. 1996 Feb 12;37(1):43-9. — View Citation

Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009 Feb;36(2):165-73. doi: 10.1016/j.amepre.2008.09.040. Review. — View Citation

Franklin VL, Waller A, Pagliari C, Greene SA. A randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetes. Diabet Med. 2006 Dec;23(12):1332-8. — View Citation

Katz J. Machines that become us: the social context of personal communication technology. New Brunswick New Jersey: Transaction Publishers, 2003.

Kessler RC, Crum RM, Warner LA, Nelson CB, Schulenberg J, Anthony JC. Lifetime co-occurrence of DSM-III-R alcohol abuse and dependence with other psychiatric disorders in the National Comorbidity Survey. Arch Gen Psychiatry. 1997 Apr;54(4):313-21. — View Citation

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McKay JR, Pettinati HM, Morrison R, Feeley M, Mulvaney FD, Gallop R. Relation of depression diagnoses to 2-year outcomes in cocaine-dependent patients in a randomized continuing care study. Psychol Addict Behav. 2002 Sep;16(3):225-35. — View Citation

Menon-Johansson AS, McNaught F, Mandalia S, Sullivan AK. Texting decreases the time to treatment for genital Chlamydia trachomatis infection. Sex Transm Infect. 2006 Feb;82(1):49-51. — View Citation

Milne RG, Horne M, Torsney B. SMS reminders in the UK national health service: an evaluation of its impact on "no-shows" at hospital out-patient clinics. Health Care Manage Rev. 2006 Apr-Jun;31(2):130-6. — View Citation

Obermayer JL, Riley WT, Asif O, Jean-Mary J. College smoking-cessation using cell phone text messaging. J Am Coll Health. 2004 Sep-Oct;53(2):71-8. — View Citation

Pal B. The doctor will text you now; is there a role for the mobile telephone in health care? BMJ 2003;326:607.

Patrick K, Raab F, Adams MA, Dillon L, Zabinski M, Rock CL, Griswold WG, Norman GJ. A text message-based intervention for weight loss: randomized controlled trial. J Med Internet Res. 2009 Jan 13;11(1):e1. doi: 10.2196/jmir.1100. — View Citation

R.B. Haynes, D. Sackett, G. Guyatt, P. Tugwell, Clinical Epidemiology: How to do Clinical Practice Research, Lippincott, Williams, Wilkins, Philadelphia, PA, 2005

Sherry E, Colloridi B, Warnke PH. Short message service (SMS): a useful communication tool for surgeons. ANZ J Surg. 2002 May;72(5):369. — View Citation

Sobell, M. B., & Sobell, L. C. (1993). Problem Drinkers: Guided Self-Change Treatment. New York: Guilford.

Tomnay JE, Pitts MK, Fairley CK. New technology and partner notification--why aren't we using them? Int J STD AIDS. 2005 Jan;16(1):19-22. Review. — View Citation

Vilella A, Bayas JM, Diaz MT, Guinovart C, Diez C, Simó D, Muñoz A, Cerezo J. The role of mobile phones in improving vaccination rates in travelers. Prev Med. 2004 Apr;38(4):503-9. — View Citation

Weaver A, Young AM, Rowntree J, Townsend N, Pearson S, Smith J, Gibson O, Cobern W, Larsen M, Tarassenko L. Application of mobile phone technology for managing chemotherapy-associated side-effects. Ann Oncol. 2007 Nov;18(11):1887-92. Epub 2007 Oct 5. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative abstinence duration which would be measured using the TLFB and collateral reports		measured at 3 months	No
Primary	Becks Depression Inventory Score		Measured at 3 Months	No
Secondary	Changes in gamma Glutamyl Transferase (Gamma GT) and Mean Corpuscular Volume (MCV) values from baseline		3 months	No
Secondary	Global Assessment of Function Score, Obsessive Compulsive Drinking Scale Scores, Alcohol Abstinence Self-Efficacy Scale Score		Measured at 3 Months	No