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Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression

S

St Patrick's Hospital, Ireland

Status

Unknown

Conditions

Dual Diagnosis

Treatments

Other: Control group
Other: Supportive text messages intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02404662
HRA-POR-2014-598

Details and patient eligibility

About

Most patients who present with problem drinking also present with mood problems. Problem drinking and mood problems co-occurring together in individuals lead them to have more severe symptoms, greater disability and poorer quality of life than individuals with only problem drinking, and they pose a greater economic burden to society due to their higher use of health services. This study aims to assess the efficacy of a new, innovative and cost effective treatment strategy aimed at reducing the burden that these co-occurring conditions impose on the suffers and their families as well as the community and health systems.

In a recent pilot study of supportive text messages for patients with problem drinking and co-occurring depression, the investigators established that patients who received twice daily supportive text messages for three months had significantly less depressive symptoms than those who did not receive such messages. There was also a trend to finding that patients who received the supportive text messages were more likely to have higher alcohol free days than those who did not receive any supportive text messages.

This study seeks to extend the knowledge gained from the pilot study. A larger group of patients with alcohol use disorder and a depressive disorder will be randomly assigned to two groups. One group will receive supportive text messages for six months duration whilst the other group will receive no supportive text messages. The patients will be followed up at 3, 6, 9 and 12 months to determine which of the two groups have less alcohol and mood problems. It is anticipated that patients receiving supportive text messages will report significantly greater alcohol free days as well as significantly less relapses, hospitalizations and mood symptoms than those not receiving such messages.

Full description

Co-morbidity of alcohol use disorder (AUD) and mood disorders presents a great challenge to health systems and exacts a tremendous toll world-wide. Individuals with a dual diagnosis have more severe symptoms, greater disability and poor quality of life than those with either diagnosis alone, and pose a greater economic burden to society due to their higher use of treatment services. New, enhanced, efficient, innovative and cost effective treatment strategies aimed at reducing the burden that the disorders impose on the suffers and their families as well as the community and health systems are required. In a pilot trial of supportive text messages for patients with alcohol use disorders and co-morbid depression, the investigators established that patients who received twice daily supportive text messages for three months had significantly less depressive symptoms than those who did not receive such messages. There was also a trend to finding that patients who received the supportive text messages were more likely to have higher cumulative abstinence duration than those who did not receive any supportive text messages.

This research seeks to extend the knowledge gained from the pilot trial. A randomised trial will be conducted on a larger sample size of patients with alcohol use disorder and a co-morbid depressive disorder (including bipolar depression) for an extended duration (6 months of supportive text messages and 1 year follow-up instead of 3 months text messages with 6 months follow-up in the pilot trial). It is hypothesised that patients receiving supportive text messages will report significantly greater cumulative abstinence duration as well as significantly less relapses, hospitalizations and mood symptoms than those not receiving such messages. It is anticipated that this technology intervention for relapse prevention will be acceptable to patients as well as cost effective.

Enrollment

107 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients who meet the criteria for both alcohol dependency syndrome/alcohol abuse and either major depressive disorder or bipolar disorder according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) and are enrolled on the in-patient dual diagnosis or addiction treatment programmes in St. Patrick's University Hospital.
  2. Able to provide written, informed consent.
  3. Mini-mental state examination (MMSE) score of ≥ 25
  4. Patients who have a mobile phone, are familiar with SMS text messaging technology and are willing to take part in the study.

Exclusion criteria

  1. Patients who do not consent to take part in the study.
  2. Patients who do not have a mobile phone or are unable to use the mobile text message technology.
  3. Patients who would be unavailable for follow-up during the study period

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

107 participants in 2 patient groups

Supportive text messages intervention
Experimental group
Description:
Patients in the intervention group will receive twice daily supportive text messages to their mobile phone for 6 months following discharge from a 4-week in-patient dual diagnosis treatment programme. The messages will be sent by a computer programme at 10am and 7pm each day and will be set up and monitored by the research worker who will not participate in follow-up assessments. They will receive a fortnightly text message thanking them for participating in the study, and a brief phone call every 2 weeks to ensure that they are still using their phone and that they have received some messages. The intervention group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings.
Treatment:
Other: Supportive text messages intervention
Control group
Active Comparator group
Description:
Patients in the control group will receive a fortnightly text message thanking them for participating in the study, and a brief phone call every 2 weeks to ensure that they are still using their phone and that they have received some messages. The control group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings.
Treatment:
Other: Control group

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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