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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Self-Hypnosis will be delivered through an interactive application administered through Amazon Alexa or Reveri.com.
Stanford Medicine - Psychiatry and Behavioral Sciences
Palo Alto, California, United States
Dept. of Psychiatry, Stanford University
Stanford, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline through month 24
Change in Perceived Stress Scale
Participant-reported outcome. Scores range from 10-50; higher scores indicate higher stress.
Time frame: Baseline through month 24
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Enrollment
152
Change in Stanford Acute Stress Reaction Questionnaire
Participant-reported outcome. Scores range from 0 to 150 with higher scores indicating higher acute stress.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through month 24
Rate of smoking reduction over time
Change in the number of self-reported daily cigarettes smoked at follow-ups will be examined.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through month 24