Just-In-Time Adaptive Interventions for Addictive Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in Opioid Craving Rating
研究概览
简要总结
Background:
Many smartphone apps intend to help people with addictions. But not enough is known about how they should work. Researchers want to study an app that gives people the advice they need, just when they need it. This is a Just-In-Time Adaptive Intervention (JITAI). To create a good JITAI, researchers need to know what approaches work best at different moments.
Objective:
To develop ways to treat addiction with a smartphone app.
Eligibility:
Adults ages 18-75 who use heroin or other opioids
Design:
Participants will be screened in another protocol.
Participants will visit a Baltimore clinic 3 days a week to give urine and breath samples.
Some participants will get their treatment at this clinic.
Participants will answer questions about their personality and stress.
Participants will randomly be assigned to the JITAI group or a comparison group.
Participants will have a training session on using the smartphone app. JITAI participants will also watch a video about the written messages they will see in the app.
Weeks 3-10: Participants will carry a smartphone. Four times a day, it will beep and ask questions. These will be about the participants' activities and mood. The JITAI group will see a short message after. The message is meant to be helpful.
For the first 16 evenings, JITAI participants will get more information on the phone.
Answers to the app's questions will be transferred automatically from the smartphone to secure computers at the NIH.
During the last week, participants can choose the kind of messages they see.
Week 11: participants will return the smartphone and answer questions.
Weeks 12-16, participants who are getting their medicine from the research clinic will be encouraged to transfer to other clinics. Otherwise, they will have their dose slowly reduced to zero.
详细描述
BACKGROUND: Our research group has made extensive use of ecological momentary assessment (EMA) to understand people's daily experiences with opioid craving, use, and lapse. We have also administered clinic-based psychotherapies such as cognitive-behavioral therapy (CBT), in which clients learn to avoid, escape, resolve, or reframe problems (such as stress) that can trigger lapses to drug use. CBT contrasts with ACT (Acceptance and Commitment Therapy), a mindfulness-based approach in which difficult thoughts and feelings are viewed as necessary and potentially valuable components of a full life, to be experienced observantly rather than resolved or reframed. CBT and ACT can and do coexist in a single treatment plan, but we know of no systematic attempt to reconcile their differences. We have also not tried to administer either of them on a mobile device.
OBJECTIVE: To test a just-in-time adaptive intervention (JITAI)-a treatment given when and where it is needed. Our JITAI will be delivered via smartphone app and will combine elements of two widely used treatments for addiction: CBT and ACT. Our goal is not to bring another branded app onto the market, but rather to clarify when and for whom the generic components of such apps are effective or not. This will include determining when CBT is more helpful than ACT and vice versa.
PARTICIPANT POPULATION: Outpatient adults who are physically dependent on opioids - up to 185 enrolled (35 for a formative-interview phase, 150 for a trial) for a target of 115 evaluable (30 interviewees, 85 trial participants). Target enrollment will include 40% women and 60% minorities (mostly African-American). In the trial, some participants will receive buprenorphine in our clinic, and others will be receiving buprenorphine or methadone elsewhere; this is a procedural matter, not a component of the experimental design.
EXPERIMENTAL DESIGN: After a formative-interview phase, the study will be run as a microrandomized trial that will also include a conventionally randomized between-groups clinical-trial component. In microrandomization, interventions are randomized at the momentary level within person; the effect is measured proximally (e.g., 20 minutes later). This is a powerful way to assess the effects of different interventions administered in the field and to examine strategy-situation fit, i.e., whether interventions are differentially effective under specific momentary circumstances. We are powering our study mostly to detect
- (1) any effect of CBT or ACT versus control moments with no intervention given, and
- (2) preferential advantages of CBT over ACT, and vice versa, as a function of the participant's ability to control (change, escape) a given situation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Opioid Craving Rating
时间窗: Within 20 minutes from receiving app message
Change in opioid craving within 20 minutes from receiving app messages. Participants designates four one-hour time bands within their typical waking hours, covering morning through late evening. During each of those time bands, the app will push a pair of assessments, given 20 minutes apart. Pre and post assessment ratings will be done using rating scale on the app from 0 to 100 ("0 = not at all" to "100- as much as possible"). Higher number indicates more opioid craving. Participants will complete ratings four times daily for 11 weeks. Analysis will be done in multilevel models.
Change in Flexibility Index Test (FIT)
时间窗: week 2 versus week 11
The Flexibility Index Test (FIT-60), a standard measure of traits associated with mindfulness, such as "I observe my feelings without losing myself in them" and "It is OK if I remember something unpleasant," and (reverse scored) "I believe that some of my thoughts are abnormal or bad and that I shouldn't think like that." Each item is rated 0 (completely disagree) to 6 (completely agree) for total score of 0 to 360. Higher score indicates better psychological flexibility. Assessment will be administered at weeks 2 and 11. Data will be analyzed via analysis of covariance (ANCOVA), with score from week 2 as the covariate to assess change (change = week 11 minus week 2).
Change in Mood Rating
时间窗: Within 20 minutes from receiving app message
Change in mood within 20 minutes from receiving app message. Rating will be done using rating scale on the app from 0 to 100 ("0 = not at all" to "100 = as much as possible"). Higher number indicates more negative mood. Participants will complete ratings four times daily for 11 weeks. Analysis will be done in multilevel models.
Change in Self-efficacy
时间窗: Within 20 minutes from receiving app message
Change in self-efficacy within 20 minutes from receiving app message. Rating will be done using rating scale on the app from 0 to 100 ("0 = not at all" to "100 = as much as possible"). Higher number indicates more positive self-efficacy. Participants will complete ratings four times daily for 11 weeks. Analysis will be done in multilevel models.
Strategy-situation Fit of Cognitive-behavioral Therapy (CBT)
时间窗: Within 20 minutes from receiving app message
The analysis will be a test of whether cognitive-behavioral therapy (CBT) messages are most effective in controllable situations and Acceptance and Commitment Therapy (ACT) messages are most effective in noncontrollable situations. A situation will be categorized as noncontrollable when a participant gives a response of less than 50/100 on either of these two "pre" items: (1) "I could easily be somewhere else right now if I wanted," (2) "I could easily get out of what I'm doing right now." Otherwise, will categorize the situation as controllable. Analysis will be done in multilevel models.
Strategy-situation Fit of Acceptance and Commitment Therapy (ACT)
时间窗: Within 20 minutes from receiving app message
The analysis will be a test of whether cognitive-behavioral therapy (CBT) messages are most effective in controllable situations and Acceptance and Commitment Therapy (ACT) messages are most effective in noncontrollable situations. A situation will be categorized as noncontrollable when a participant gives a response of less than 50/100 on either of these two "pre" items: (1) "I could easily be somewhere else right now if I wanted," (2) "I could easily get out of what I'm doing right now." Otherwise, will categorize the situation as controllable. Analysis will be done in multilevel models.
Change in Coping Self-efficacy
时间窗: week 2 versus week 11
Participants coping self-efficacy will be assessed using the Drug-Taking Confidence Questionnaire (DTCQ-8), an 8-item measure of coping self-efficacy in the context of resisting lapses to drug misuse and administered by clinician. Each item is scored from 0 to 100. Higher score indicates more confidence. Assessment will be administered at weeks 2 and 11. Data will be analyzed via analysis of covariance (ANCOVA), with score from week 2 as the covariate to assess change (change = week 11 minus week 2).
Change in Coping-style Flexibility
时间窗: week 2 versus week 11
Coping-style flexibility was assessed using the Coping Orientation to Problems Experienced (COPE) questionnaire, a 60-item self-report scale assessing both general coping styles and coping behaviors in specific situations. Each item is rated 1 = I usually don't do this at all, to 4 = I usually do this a lot, with total score of 60 to 240. Higher score indicates improved coping. Assessment will be administered at weeks 2 and 11. Data will be analyzed via analysis of covariance (ANCOVA), with score from week 2 as the covariate to assess change (change = week 11 minus week 2).
次要结局
未报告次要终点