Single Blind Randomised Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Cumulative abstinence duration (CAD).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Able to provide written, informed consent.
- •Mini-mental state examination (MMSE) score of ≥ 25
- •Patients who have a mobile phone, are familiar with SMS text messaging technology and are willing to take part in the study.
排除标准
- •Patients who do not consent to take part in the study.
- •Patients who do not have a mobile phone or are unable to use the mobile text message technology.
- •Patients who would be unavailable for follow-up during the study period
研究组 & 干预措施
Supportive text messages intervention
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.
干预措施: Supportive text messages intervention (Other)
Control group
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.
干预措施: Control group (Other)
结局指标
主要结局
Cumulative abstinence duration (CAD).
时间窗: 12 months following discharge from the inpatient treatment programme.
CAD will be assessed using the timeline to follow-back (TLFB). This will be used to record the quantity of alcohol consumed and number of drinking days.
Changes in Beck's Depression Inventory (BDI) scores from baseline.
时间窗: BDI will be administered at baseline (during the in-patient treatment programme for dual diagnosis), and then at 3, 6, 9 and 12 months post-discharge from hospital.
The BDI is a self-administered questionnaire widely used to assess depressive symptoms. It takes approximately 5 minutes to complete.
次要结局
- Time to first drink.(3, 6, 9 and 12 months post-discharge.)
- Perception of patients in the intervention group about the usefulness of supportive text messages.(6 months post-discharge)
- Proportion of patients continuously abstinent from alcohol at 6 and 12 months.(6 and 12 months post-discharge.)
- Changes from baseline in scores on the modified global assessment of function (m-GAF) scale.(This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.)
- Changes from baseline in scores on the alcohol expectancy questionnaire (AEQ).(This scale will be administered at baseline and then at 3, 6, 9 and 12 months.)
- Changes from baseline in scores on the obsessive compulsive drinking scale (OCDS).(This scale will be administered at baseline and then at 3, 6, 9 and 12 months.)
- Changes from baseline in scores on the alcohol abstinence self-efficacy scale (AASES).(These scales will be administered at baseline and then at 3, 6, 9 and 12 months.)
- Changes from baseline in scores on the perceived stress scale (PSS).(This scale will be administered at baseline and then at 3, 6, 9 and 12 months.)
- Changes from baseline in scores on the young mania rating scale (YMRS).(This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.)
- Changes from baseline in blood measures of alcohol abuse.(Blood samples will be analysed at baseline, then at 3, 6, 9 and 12 months following discharge.)
- Patient satisfaction with overall treatment protocol in both groups(3, 6, 9 and 12 months)
研究者
Dr. Conor Farren
Associate Clinical Professor, Trinity College Dublin; Consultant Psychiatrist, St Patrick's University Hospital
St Patrick's Hospital, Ireland