Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder- Q-IV Scale
研究概览
简要总结
The majority of opioid users meet criteria for anxiety and depressive disorders, but most substance use disorder treatment programs do not offer treatment for co-occurring mental health problems. Anxiety and depression may also be directly linked to opioid use itself. Although treatments have been developed for anxiety and depressive symptoms for opioid users within face-to-face settings, few treatment facilities offer these in-person interventions due to their high cost and time burden. Given the deficits in research on treatments for anxiety and depression among those with opioid use disorder, the current research will examine the efficacy of a digital intervention designed to treat anxiety and depressive symptoms by augmenting the state of the science medication-based opioid use disorder treatment. Over the course of the proposed study, the research team will design and test the feasibility and acceptability of a standalone mobile intervention designed to treat persons receiving medication treatment for opioid use disorder. Participants receiving medication treatment for opioid use disorder will be randomized to receive a digital intervention to treat anxiety and depression or care as usual for a total of four weeks. The overarching goal of the proposed work is to test the feasibility and acceptability of the proposed mobile intervention. The Investigators will also explore the preliminary efficacy by examining reductions in anxiety and depressive symptoms and opioid cravings and use. This work could lead to a low-cost scalable solution to augment gold-standard treatment as usual in opioid use disorder by decreasing levels of comorbidity of anxiety and depressive disorders, thereby ultimately improving the outcomes of opioid use disorder itself.
详细描述
The study team will recruit a population of 60 adults who are receiving medication treatment for OUD from an online study based on Google Adwords, Reddit, and Facebook advertisements as online recruitment has been shown to be a viable and cost-effective recruitment method for opioid users. The total sample size may be expanded if recruitment costs are lower than expected.
Participants will complete self-report assessments on their anxiety symptoms, depressive symptoms, opioid cravings, and opioid use behaviors. Participants will be randomized to a smartphone-based digital intervention or waitlist control condition. The digital intervention will be designed to treat participants' anxiety and depressive symptoms, and participants will be asked to use the intervention four times per week for four weeks (16 digital sessions).The smartphone intervention will also collect passive sensing data continuously during the 4 week period. Participants will complete post measures and one-month follow-up measures on anxiety symptoms, depressive symptoms, opioid cravings, and opioid use behaviors. The urine drug screen will be mailed to participants. Participants will also be asked to complete five urine tests to detect substance use (amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, marijuana, methamphetamine, opioids, oxycodone, and pcp) across the study (1 at pre-digital intervention, 1 during the digital intervention, 1 post-digital intervention, 1 between post and follow-up of the digital intervention, and 1 at the 1-month follow-up of the digital intervention). Participants will be instructed when to complete each urine test and will be asked to take a photo of the back the label of each test showing the results to the experimenters and to text these photos to a Google Voice Number maintained by the experimenters.
Thus, this proposal seeks to address a crucial deficit in the availability of treatments for anxiety and depressive disorders among persons with OUD to ultimately augment treatment for OUD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults (age 18 or older)
- •fluent in English
- •able to provide informed consent
- •meet current criteria for OUD (as defined by a Rapid Opioid Dependence Screen)
- •are receiving methadone, buprenorphine, and/or naltrexone for OUD
- •meet current criteria for an anxiety and/or depressive disorder (based on the Patient Health Questionnaire and the Generalized Anxiety Disorder Questionnaire).
排除标准
- •active suicidality
- •psychosis
- •bipolar disorder
结局指标
主要结局
Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder- Q-IV Scale
时间窗: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
Change in Depressive Symptoms as Assessed by Patient Health Questionnaire-9
时间窗: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Assesses depressive symptoms, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day)
Change in Likelihood of a Positive Urine Screen for Opioids (MOP)
时间窗: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
This outcome measures the change in the likelihood of a positive urine drug screen (UDS) for opioids (MOP). The result of each UDS was coded as a binary variable (0 = negative test, 1 = positive test). The reported data are the beta coefficients (estimated mean change) from a robust linear mixed-effects model, which are presented on a unitless scale. A negative value indicates a reduction in the likelihood of testing positive and represents a better outcome.
次要结局
- Change in Opioid Use Disorder Severity as Measured by the Rapid Opioid Dependence Screen (RODS)(From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).)
- Change in Opioid Craving as Measured by the Opioid Craving Scale (OCS)(From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).)
研究者
Nicholas Jacobson
Principal Investigator
Trustees of Dartmouth College