Agyapong Vincent Israel Opoku, Mrklas Kelly, Suen Victoria Yung Mei, Rose Marianne Sarah, Jahn Megan, Gladue Irene, Kozak Jody, Leslie Maureen, Dursun Serdar, Ohinmaa Arto, Greenshaw Andrew
Faculty of Health Sciences, Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.
JMIR Res Protoc. 2015 May 15;4(2):e55. doi: 10.2196/resprot.4371.
Depression and Alcohol Use Disorders (AUDs) are two leading causes of disability worldwide and are associated with significant treatment challenges requiring new, innovative, cost-effective and technologically-based therapies including the use of supportive text messages.
To determine the feasibility and effectiveness of supportive text messages in long-term follow-up to reduce mood symptoms and problem drinking in patients with Depression or AUD respectively and to explore the usefulness of self-reports of health services utilization as an outcomes measure.
This will be a longitudinal, prospective, parallel-design, two-arm, placebo-controlled single-rater-blinded randomized clinical trial with a recruitment period of 6 months and an observation period of 12 months for each participant, with two strata based on primary diagnosis of Major Depressive Disorder or AUD. The sample size will be 120, with about 60 patients randomized from each primary diagnostic grouping. Patients in all intervention groups will receive twice-daily supportive SMS text messages for 3 months and then daily supportive text messages for the next three months. Patients will also receive a phone call every two weeks from the research assistant assigning treatment allocation to confirm that they are still receiving the text messages and to thank them for taking part in the study. Patients in the control group will receive no text messages but will also receive a phone call from the same research assistant every two weeks to thank them for taking part in the study.
The study starts in April 2015 and ends in September 2016. It is envisaged that both qualitative and quantitative primary and secondary outcomes, including patient perceptions of the intervention, will shed light on the feasibility of using automated supportive text message interventions in long term for patients with Depression and AUD. This will inform a full-scale clinical trial.
The paradigm for behavior change using text messages as a patient-direct intervention is consistent with a cognitive behavior therapy approach and addictions counselling principles. Given the automaticity of the messages, we anticipate that if the intervention proves successful, it will represent a low cost strategy that will be readily available and can bring relief to patients in hard-to-reach areas with limited access to psychological therapies.
ClinicalTrials.gov: NCT02327858; https://clinicaltrials.gov/ct2/show/NCT02327858 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02327858).
抑郁症和酒精使用障碍（AUDs）是全球导致残疾的两大主要原因，且与重大治疗挑战相关，需要新的、创新的、具有成本效益的和基于技术的疗法，包括使用支持性短信。
确定支持性短信在长期随访中分别减轻抑郁症或酒精使用障碍患者的情绪症状和问题饮酒的可行性和有效性，并探索将卫生服务利用的自我报告作为一种结果测量指标的有用性。
这将是一项纵向、前瞻性、平行设计、双臂、安慰剂对照、单评定者盲法随机临床试验，招募期为6个月，每位参与者的观察期为12个月，根据重度抑郁症或酒精使用障碍的初步诊断分为两个层次。样本量为120例，每个主要诊断组约60例患者随机分组。所有干预组的患者将在3个月内每天收到两次支持性短信，然后在接下来的三个月内每天收到支持性短信。患者还将每两周接到一次由负责分配治疗分组的研究助理打来的电话，以确认他们仍在接收短信并感谢他们参与研究。对照组的患者将不接收短信，但同样每两周会接到这位研究助理打来的电话，感谢他们参与研究。
该研究于2015年4月开始，2016年9月结束。预计定性和定量的主要及次要结果，包括患者对干预措施的看法，将揭示长期使用自动支持性短信干预对抑郁症和酒精使用障碍患者的可行性。这将为全面的临床试验提供参考。
使用短信作为患者直接干预手段的行为改变模式与认知行为疗法方法和成瘾咨询原则相一致。鉴于短信的自动性，我们预计如果干预措施证明成功，它将代表一种低成本策略，随时可用，并能为难以获得心理治疗的偏远地区患者带来缓解。
ClinicalTrials.gov：NCT02327858；https://clinicaltrials.gov/ct2/show/NCT02327858（由WebCite存档于https://clinicaltrials.gov/ct2/show/NCT02327858）。
