Pilot Study Evaluating the Feasibility and Effects of an Innovative Automated Hypnosis Intervention for Smoking Cessation and Pain and Stress Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 4
- 主要终点
- Change in Brief Pain Inventory-Pain Interference Score
研究概览
简要总结
After developing professional quality materials (audio) for an affordable automated self-hypnosis intervention program for facilitating smoking cessation, stress and pain reduction, researchers aim to gain qualitative reviews of this program, and test its initial feasibility and effects on smoking cessation and reduction in pain and stress.
In addition, this study seeks to determine whether higher hypnotizability, as measured by the Hypnotic Induction Profile (assessed at baseline), is a moderator of improved outcome in these conditions.
详细描述
The investigators are interested in recruiting individuals who report that they smoke cigarettes daily and are motivated to make a serious attempt at quitting, and individuals who report experiencing pain or stress, who are willing to try to use the hypnosis intervention and provide feedback regarding their experience with the intervention.
The original intervention is an interactive hypnosis tool, developed by Reveri Health, utilizing periodic questions and answers to personalize the session progression and emulate the conversational nature of an in-person session designed based upon decades of clinical hypnosis research and experience at the Stanford Center on Stress and Health. The intervention is delivered through the Amazon Alexa platform's beta testing tool. Participants will be provided with the Alexa Dot device, which is sold by Amazon and widely used by consumers. Later on, research participants will have the option of using an Alexa-supported smartphone device without the Alexa Dot speaker. Those enrolled later in the study will instead be offered the use of the interactive app also developed by Reveri (www.reveri.com) independent of the Alexa platform. What will be specific to this pilot is the hypnosis training approach, including the interactive nature of the program. The structure and the content of the hypnosis training program will be the same across the 3 mentioned modes of administration. The user interface for the app is the main difference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •18 years or older
- •Able to read and understand English
- •For the smokers, desire to quit smoking (specifically, report a motivation of ≥ 5 out of 10 to quit smoking on a 10-point Likert-type scale), and report being a daily smoker for at least one year, smoking an average ≥ 5 cigarettes per day
- •For the pain group, report suffering from chronic pain syndromes, such as fibromyalgia or chronic low back pain
- •For the stress group, report experiencing moderate to extreme stress or anxiety in the past month
- •Having access to wireless internet connection or mobile data
排除标准
- •Meeting criteria for drug abuse, including use of dissociative anesthetics, hallucinogens, opioids, cocaine, or amphetamine within the last 3 months
- •Severe psychiatric or structural brain disease (i.e. psychosis, stroke with functional impairment, dementia) or current/recent risk to self
- •Hearing impairment that would impede ability to listen the auditory intervention
- •Major illnesses impacting the study results
- •For smokers, currently taking Wellbutrin, Chantix, or other pharmacological smoking cessation aids that could confound results of the study
结局指标
主要结局
Change in Brief Pain Inventory-Pain Interference Score
时间窗: Baseline through month 24
Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain.
Change in Impact of Event Scale - Revised
时间窗: Baseline through month 24
Participant-reported outcome evaluating subjective stress caused by traumatic events, where scores range from 0-88 and higher scores indicate higher subjective stress.
Change in State-Trait Anxiety Inventory Form X
时间窗: Baseline through month 24
Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher state anxiety.
Change in Positive and Negative Affect Scale-Negative Affect Scale Score
时间窗: Baseline through month 24
Participant-reported outcome. This reporting tool has positive and negative affect scales; the negative affect scale is a primary outcome measure in this study. Scores range from 10-50 and higher scores indicate higher negative affect.
Change in McGill Pain Questionnaire
时间窗: Baseline through month 24
Participant-reported outcome. Scores range from 0-78 and the higher the pain score the greater the pain.
Change in PROMIS SF v1.0 Pain Interference 4a short form
时间窗: Baseline through month 24
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher pain.
Rate of Self-reported smoking cessation
时间窗: Baseline through month 24
The question, with a dichotomous (yes/no) response, "Have you succeeded in stopping smoking completely?" will be asked via online survey. Researchers will use responses of "Yes" to indicate abstinence.
Change in Brief Pain Inventory-Pain Severity Score
时间窗: Baseline through month 24
Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain.
Change in PROMIS Global Pain Intensity (Pain Intensity 1a)
时间窗: Baseline through month 24
Participant-reported outcome. Scores range from 0 (no pain) to 10 (Worst imaginable pain).
Change in Perceived Stress Scale
时间窗: Baseline through month 24
Participant-reported outcome. Scores range from 10-50; higher scores indicate higher stress.
Change in Stanford Acute Stress Reaction Questionnaire
时间窗: Baseline through month 24
Participant-reported outcome. Scores range from 0 to 150 with higher scores indicating higher acute stress.
Change in State-Trait Anxiety Inventory Form Y
时间窗: Baseline through month 24
Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher trait anxiety.
次要结局
- Change in PROMIS SF v1.0 Ability to Participate in Social Roles and Activities 4a short form(Baseline through month 24)
- Change in PROMIS SF v1.0 Fatigue 4a short form(Baseline through month 24)
- Rate of smoking reduction over time(Baseline through month 24)
- Change in PROMIS SF v1.0 Physical Function 4a short form(Baseline through month 24)
- Change in PROMIS SF v1.0 Anxiety 4a short form(Baseline through month 24)
- Change in PROMIS SF v1.0 Sleep Disturbance 4a short form(Baseline through month 24)
- Change in Pittsburgh Sleep Quality Index(Baseline through month 24)
- Change in PROMIS SF v1.0 Depression 4a short form(Baseline through month 24)
- Change in Positive and Negative Affect Scale-Positive Affect Scale Score(Baseline through month 24)
- Change in Brief Cope Scale(Baseline through month 24)
研究者
David Spiegel
Jack, Lulu and Sam Willson Professor and Associate Chair of Psychiatry & Behavioral Sciences, Director Center on Stress and Health
Stanford University