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DepressionNCT01037868

Usefulness of Supportive Text Messages in the Treatment of Depressed Alcoholics

A study testing Supportive SMS text messages in people with Depression and Alcohol Use Disorder, run by University of Dublin, Trinity College at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Depression, Alcohol Use Disorder
What is being tested?
Supportive SMS text messages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteIreland
Study dates
Sep 2009to Jan 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ireland1 site
  • St Patrick's University Hospital

    Dublin

Other trials in Ireland

About this study

Official title: 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).

Read more

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.

Read the 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.

Being tested
Supportive SMS text messages
Keywords
depression, alcohol dependency syndrome, dual diagnosis, SMS text messages
Medical subject headings
Depression, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supportive SMS text messagesOther

    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.

Study groups in NCT01037868
Study groupRoleWhat they receive
Supportive SMS messagesExperimentalPatients 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.
Receives: Other: Supportive SMS text messages
No supportive SMS text messageNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative abstinence duration which would be measured using the TLFB and collateral reports

    Measured: measured at 3 months

  2. Becks Depression Inventory Score

    Measured: Measured at 3 Months

Secondary outcomes (2)
  1. Changes in gamma Glutamyl Transferase (Gamma GT) and Mean Corpuscular Volume (MCV) values from baseline

    Measured: 3 months

  2. Global Assessment of Function Score, Obsessive Compulsive Drinking Scale Scores, Alcohol Abstinence Self-Efficacy Scale Score

    Measured: Measured at 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01037868
Sponsor's protocol ID
UDublinTC
Status last verified
Mar 2013
First submitted
22 Dec 2009
Last updated
28 Mar 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19135907
  • 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. doi: 10.1001/archpsyc.1997.01830160031005.

    PubMed 9107147
  • Brady KT, Sonne SC. The relationship between substance abuse and bipolar disorder. J Clin Psychiatry. 1995;56 Suppl 3:19-24.

    PubMed 7883738
  • 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. doi: 10.1176/ajp.155.2.220.

    PubMed 9464201
  • 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. doi: 10.1016/0165-0327(95)00080-1.

    PubMed 8682977
  • 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.

    PubMed 12236457
  • 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. doi: 10.1176/ajp.155.2.239.

    PubMed 9464204
  • 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. doi: 10.1016/j.jad.2007.07.006. Epub 2007 Aug 16.

    PubMed 17707085
  • Katz J. Machines that become us: the social context of personal communication technology. New Brunswick New Jersey: Transaction Publishers, 2003.

  • Ling R. The mobile connection: the cell phone's impact on society. San Francisco: Morgan Kaufmann Publishers, 2004.

  • 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.

    PubMed 19141433
  • 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. doi: 10.3200/JACH.53.2.71-78.

    PubMed 15495883
  • 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. doi: 10.1111/j.1464-5491.2006.01989.x.

    PubMed 17116184
  • 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. doi: 10.1016/j.ajodo.2004.11.014.

    PubMed 15775951

Questions about this trial

What is this clinical trial studying?

A study testing Supportive SMS text messages in people with Depression and Alcohol Use Disorder, run by University of Dublin, Trinity College at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative abstinence duration which would be measured using the TLFB and collateral reports (time frame: measured at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01037868, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2013.

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