Supportive Text Messages to Reduce Mood Symptoms and Problem Drinking in Patients With Primary Depression or Alcohol Use Disorder - Randomised Controlled Pilot Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Mean changes in the BDI scores from baseline for those with a primary diagnosis of Depression
研究概览
简要总结
According to the World Health Organisation, depression and problem drinking are among the leading causes of disability worldwide. Most patients who present with problem drinking and/or depression have poor quality of life and pose a great economic burden to society due to their higher use of health services. We seek to develop a new, enhanced, efficient, innovative and cost effective treatment strategy aimed at reducing the burden that these two mental conditions impose on sufferers, their families as well as the community and health systems. In a recent pilot study of supportive text messages in Ireland conducted by the Principal Applicant and a team of researchers for patients with problem drinking and co-occurring depression, we 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 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.Our study was limited by the small number of participants and it did not examine the impact of the text messages on health services utilization. Our study did not also examine the effects of supportive text messages on those with only depression or only problem drinking. The proposed study seeks to extend the knowledge gained from the pilot study in Ireland by examining the impact of supportive text messages in the individual disorders
详细描述
Depression and Alcohol Use Disorders (AUDs) are leading causes of disability worldwide associated with significant treatment challenges especially when they occur concurrently (1). Concurrent challenges include: Higher rates of lifetime drug dependence (2); worse outcomes among those entering treatment for alcohol and drug misuse (3); higher relapse following AUD treatment among adolescents (4) and adults (5); greater severity of suicidality in adults (6) higher likelihood of suicide attempts (7) and completed suicides (8). Because of this we seek to develop a complimentary enhanced, efficient, innovative and cost effective treatment strategy aimed at reducing the burden these disorders impose on service users, care givers, their communities and Alberta Health Services. Using mobile phone technology (9). In a pilot trial In Ireland, participants with concurrent depression and AUD who completed an in-patient dual diagnosis treatment program were randomised to receive twice daily supportive text messages or a two weekly thank you text message for three months. That trial showed that supportive text messaging improved symptoms of depression (Beck Depression Inventory scores) compared with those who received only standard care. There was also a trend towards increased Cumulative Abstinence Duration (CAD) in the supportive text message group (10). The pilot trial in Ireland did not explore the effects of supportive text messages on the individual disorders when they occur alone, although it would be reasonable to assume that they would benefit equally. A recent study in JAMA Psychiatry (11) (randomising patients leaving residential treatment for alcohol use disorders to receive either a smart-phone application to support recovery in addition to treatment as usual or only treatment as usual) reported that for the 8 months of the intervention and 4 months of follow-up, patients in the smart phone application support group reported significantly fewer risky drinking days than did patients in the control group. In a review of text messaging for clinical and healthy behaviour interventions, Wei et al. (2011) found that among sixteen randomized controlled trials, ten reported significant improvement with interventions and six reported differences suggesting positive trends (12).
Overall Aim: To conduct a randomised controlled pilot trial to determine the effectiveness of supportive text messages in reducing mood symptoms and problem drinking in patients with Depression and/or AUD respectively.
Specific objectives:
- To compare mean changes in Beck's Depression Inventory (BDI) from baseline for patients with Depression receiving supportive text messages with those not receiving any supportive text messages.
- To compare the Cumulative Abstinence Duration (CAD) from baseline for patients with AUD receiving supportive text messages with those not receiving any supportive text messages..
Hypotheses:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons aged over 18 years who are able to provide informed consent,
- •Patient must have been assessed by a psychiatrist and fulfil the DSM-5 diagnostic criteria for Major Depressive Disorder or have completed the residential addiction treatment programme located at the Northern Addiction Treatment Centre and fulfil the DSM-5 diagnostic criteria for Alcohol Use Disorder.
- •They must be familiar with or willing to learn how to receive text messages and will be available for follow-up.
排除标准
- •Patients who do not meet the above inclusion criteria
- •Patients with Schizophrenia, Schizoaffective Disorder, Bipolar Disorder and other psychotic disorders. - -People who are living outside of regular cell phone connection areas
结局指标
主要结局
Mean changes in the BDI scores from baseline for those with a primary diagnosis of Depression
时间窗: 3 Months
Cumulative Abstinence Duration from baseline (Since discharge from the Residential Addiction treatment programme) for those with AUD.
时间窗: 3 Months
次要结局
- Mean units of alcohol per drinking days for participants with AUD(3 Months)
- Mean Days to first drink for participants with AUD(3 Months)
- Number of hazardous drinking days from baseline for participants with AUD(3 Months)
- Health related Quality of Life will be measured using the EQ-5D-5L (Canadian version)(3 Months)
研究者
Vincent Agyapong
Clinical Associate Professor
University of Alberta