Pain, Smoking, Stress
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALAutomated Self-Hypnosis
Self-Hypnosis will be delivered through an interactive application administered through Amazon Alexa or Reveri.com.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a pilot, open trial evaluating a novel automated hypnosis intervention for smoking cessation and pain and reduction
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in State-Trait Anxiety Inventory Form Y | Baseline through month 24 | Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher trait anxiety. |
| Change in Brief Pain Inventory-Pain Interference Score | Baseline through month 24 | Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain. |
| Change in Brief Pain Inventory-Pain Severity Score | Baseline through month 24 | Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain. |
| Change in McGill Pain Questionnaire | 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 | 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. |
| Change in PROMIS Global Pain Intensity (Pain Intensity 1a) | Baseline through month 24 | Participant-reported outcome. Scores range from 0 (no pain) to 10 (Worst imaginable pain). |
| Change in Perceived Stress Scale | Baseline through month 24 | Participant-reported outcome. Scores range from 10-50; higher scores indicate higher stress. |
| Change in Stanford Acute Stress Reaction Questionnaire | Baseline through month 24 | Participant-reported outcome. Scores range from 0 to 150 with higher scores indicating higher acute stress. |
| Change in Impact of Event Scale - Revised | 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 Positive and Negative Affect Scale-Negative Affect Scale Score | 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 State-Trait Anxiety Inventory Form X | Baseline through month 24 | Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher state anxiety. |
| Rate of Self-reported smoking cessation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS SF v1.0 Physical Function 4a short form | 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 physical function. |
| Change in PROMIS SF v1.0 Anxiety 4a short form | 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 anxiety. |
| Change in PROMIS SF v1.0 Depression 4a short form | 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 depression. |
| Change in PROMIS SF v1.0 Fatigue 4a short form | 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 fatigue. |
| Change in PROMIS SF v1.0 Sleep Disturbance 4a short form | 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 sleep disturbance. |
| Change in PROMIS SF v1.0 Ability to Participate in Social Roles and Activities 4a short form | 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 ability to participate in social roles and activities. |
| Change in Positive and Negative Affect Scale-Positive Affect Scale Score | Baseline through month 24 | 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. |
| Change in Brief Cope Scale | Baseline through month 24 | Participant-reported outcome. Scores range from 2-8 and higher scores indicate greater ability to cope. |
| Change in Pittsburgh Sleep Quality Index | Baseline through month 24 | Participant-reported outcome of change in sleep quality. Scores range from 0-21 and higher scores indicate worse sleep quality. |
| Rate of smoking reduction over time | Baseline through month 24 | Change in the number of self-reported daily cigarettes smoked at follow-ups will be examined. |
Countries
United States
Outcome results
None listed