Clinical trial NCT01037868: Usefulness of Supportive Text Messages in the Treatment of Depressed Alcoholics
Official title: A Randomised Trial on the Usefulness of Supportive Text Messages in the Treatment of Depressed Patients With Co-morbid Alcohol Dependency Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Alcohol Use Disorder
Keywords: depression
alcohol dependency syndrome
dual diagnosis
SMS text messages
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: St Patrick's Hospital, Ireland
First posted: 2009-12-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Cumulative abstinence duration which would be measured using the TLFB and collateral reports
timeFrame: measured at 3 months
measure: Becks Depression Inventory Score
timeFrame: Measured at 3 Months
Secondary outcomes:
measure: Changes in gamma Glutamyl Transferase (Gamma GT) and Mean Corpuscular Volume (MCV) values from baseline
timeFrame: 3 months
measure: Global Assessment of Function Score, Obsessive Compulsive Drinking Scale Scores, Alcohol Abstinence Self-Efficacy Scale Score
timeFrame: Measured at 3 Months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St Patrick's University Hospital
Study officials:
affiliation: University of Dudlin Trinity College & St Patricks University Hospital
name: Declan McLoughlin, PhD
role: STUDY_CHAIR
affiliation: St Patrick's University Hospital
name: Conor Farren, PhD
role: STUDY_DIRECTOR
affiliation: University of Dublin, Trinity College Dublin
name: Vincent IO Agyapong, MSc MRCPsych
role: PRINCIPAL_INVESTIGATOR
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