Online Automated Self-Hypnosis Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study Evaluating the Feasibility and Effects of an Innovative Automated Hypnosis Intervention for Smoking Cessation and Pain and Stress Reduction

Conditions
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Smoking, Pain, Stress

Intervention / Treatment
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* Behavioral: Automated Self-Hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion/Exclusion criteria for the three arms, with exceptions noted below: Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a pilot, open trial evaluating a novel automated hypnosis intervention for smoking cessation and pain and reduction
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated Self-Hypnosis Intervention for Smoking Cessation<br>Participants will first try this intervention at their Baseline visit following an assessment of trait hypnotizability. After being guided through the program by their experimenter (i.e., set-up procedures in addition to the actual hypnotic exercise) participants will provide initial feedback on the program through a series of questions. The entire appointment will take approximately one hour and will take place at The Center on Stress and Health. Participants will be provided with the Amazon Alexa device to take home (necessary for using the program), or the interactive Reveri (www.reveri.com) mobile app. After the lab visit participants will continue using the intervention at home as needed throughout the 24 months of study participation (recommended every few hours or whenever they feel the urge to smoke). Furthermore, participants will be taking an online 15-minute survey at the baseline visit, and then 1, 3, 6, 12 and 24-month online follow-up surveys at home. | Behavioral: Automated Self-Hypnosis<br>* Self-Hypnosis will be delivered through an interactive application administered through Amazon Alexa or Reveri.com.<br>|
| Experimental: Automated Self-Hypnosis Intervention for Pain Reduction<br>Participants will first try this intervention at their Baseline visit following an assessment of trait hypnotizability. After being guided through the program by their experimenter (i.e., set-up procedures in addition to the actual hypnotic exercise) participants will provide initial feedback on the program through a series of questions. The entire appointment will take approximately one hour and will take place at The Center on Stress and Health, or remotely during the COVID-19 pandemic. Participants will be provided with the Amazon Alexa device to take home (necessary for using the program), or the interactive Reveri (www.reveri.com) mobile app. After the lab or remote visit participants will continue using the intervention at home as needed (recommended every few hours or whenever they experience an increase in pain). Furthermore, participants will be taking an online 15-minute survey at the baseline visit, and then 1, 3, 6, 12 and 24-month online follow-up surveys at home. | Behavioral: Automated Self-Hypnosis<br>* Self-Hypnosis will be delivered through an interactive application administered through Amazon Alexa or Reveri.com.<br>|
| Experimental: Automated Self-Hypnosis Intervention for Stress Reduction<br>Participants will first try this intervention at their Baseline visit following an assessment of trait hypnotizability. After being guided through the program by their experimenter (i.e., set-up procedures in addition to the actual hypnotic exercise) participants will provide initial feedback on the program through a series of questions. The entire appointment will take approximately one hour and will take place at The Center on Stress and Health, or remotely during the COVID-19 pandemic. Participants will be provided with the Amazon Alexa device to take home (necessary for using the program), or the interactive Reveri (www.reveri.com) mobile app. After the lab or remote visit participants will continue using the intervention at home as needed (recommended every few hours or whenever they experience an increase in stress). Furthermore, participants will be taking an online 15-minute survey at the baseline visit, and then 1, 3, 6, 12 and 24-month online follow-up surveys at home. | Behavioral: Automated Self-Hypnosis<br>* Self-Hypnosis will be delivered through an interactive application administered through Amazon Alexa or Reveri.com.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Self-reported smoking cessation | 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. | Baseline through month 24 | 
| Change in Brief Pain Inventory-Pain Interference Score | Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain. | Baseline through month 24 | 
| Change in Brief Pain Inventory-Pain Severity Score | Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain. | Baseline through month 24 | 
| Change in McGill Pain Questionnaire | Participant-reported outcome. Scores range from 0-78 and the higher the pain score the greater the pain. | Baseline through month 24 | 
| Change in PROMIS SF v1.0 Pain Interference 4a short form | 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. | Baseline through month 24 | 
| Change in PROMIS Global Pain Intensity (Pain Intensity 1a) | Participant-reported outcome. Scores range from 0 (no pain) to 10 (Worst imaginable pain). | Baseline through month 24 | 
| Change in Perceived Stress Scale | Participant-reported outcome. Scores range from 10-50; higher scores indicate higher stress. | Baseline through month 24 | 
| Change in Stanford Acute Stress Reaction Questionnaire | Participant-reported outcome. Scores range from 0 to 150 with higher scores indicating higher acute stress. | Baseline through month 24 | 
| Change in Impact of Event Scale - Revised | Participant-reported outcome evaluating subjective stress caused by traumatic events, where scores range from 0-88 and higher scores indicate higher subjective stress. | Baseline through month 24 | 
| Change in Positive and Negative Affect Scale-Negative Affect Scale Score | 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. | Baseline through month 24 | 
| Change in State-Trait Anxiety Inventory Form X | Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher state anxiety. | Baseline through month 24 | 
| Change in State-Trait Anxiety Inventory Form Y | Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher trait anxiety. | Baseline through month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of smoking reduction over time | Change in the number of self-reported daily cigarettes smoked at follow-ups will be examined. | Baseline through month 24 | 
| Change in PROMIS SF v1.0 Physical Function 4a short form | 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 physical function. | Baseline through month 24 | 
| Change in PROMIS SF v1.0 Anxiety 4a short form | 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 anxiety. | Baseline through month 24 | 
| Change in PROMIS SF v1.0 Depression 4a short form | 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 depression. | Baseline through month 24 | 
| Change in PROMIS SF v1.0 Fatigue 4a short form | 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 fatigue. | Baseline through month 24 | 
| Change in PROMIS SF v1.0 Sleep Disturbance 4a short form | 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 sleep disturbance. | Baseline through month 24 | 
| Change in PROMIS SF v1.0 Ability to Participate in Social Roles and Activities 4a short form | 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 ability to participate in social roles and activities. | Baseline through month 24 | 
| Change in Positive and Negative Affect Scale-Positive Affect Scale Score | Participant-reported outcome. This reporting tool has positive and negative affect scales; the positive affect scale is a secondary outcome measure in this study. Scores range from 10-50 and higher scores indicate higher positive affect. | Baseline through month 24 | 
| Change in Brief Cope Scale | Participant-reported outcome. Scores range from 2-8 and higher scores indicate greater ability to cope. | Baseline through month 24 | 
| Change in Pittsburgh Sleep Quality Index | Participant-reported outcome of change in sleep quality. Scores range from 0-21 and higher scores indicate worse sleep quality. | Baseline through month 24 |