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Completed

NCT Number: NCT03931772

Online Automated Self-Hypnosis Program

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.

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Key information

Conditions

Smoking Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Medicine - Psychiatry and Behavioral Sciences, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated Self-Hypnosis

Behavioral

Self-Hypnosis will be delivered through an interactive application administered through Amazon Alexa or Reveri.com.

Primary outcomes

  1. Rate of Self-reported smoking cessation

    Time frame: 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.

  2. Change in Brief Pain Inventory-Pain Interference Score

    Time frame: Baseline through month 24

    Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain.

  3. Change in Brief Pain Inventory-Pain Severity Score

    Time frame: Baseline through month 24

    Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain.

  4. Change in McGill Pain Questionnaire

    Time frame: Baseline through month 24

    Participant-reported outcome. Scores range from 0-78 and the higher the pain score the greater the pain.

  5. Change in PROMIS SF v1.0 Pain Interference 4a short form

    Time frame: 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.

  6. Change in PROMIS Global Pain Intensity (Pain Intensity 1a)

    Time frame: Baseline through month 24

    Participant-reported outcome. Scores range from 0 (no pain) to 10 (Worst imaginable pain).

  7. Change in Perceived Stress Scale

    Time frame: Baseline through month 24

    Participant-reported outcome. Scores range from 10-50; higher scores indicate higher stress.

  8. Change in Stanford Acute Stress Reaction Questionnaire

    Time frame: Baseline through month 24

    Participant-reported outcome. Scores range from 0 to 150 with higher scores indicating higher acute stress.

  9. Change in Impact of Event Scale - Revised

    Time frame: 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.

  10. Change in Positive and Negative Affect Scale-Negative Affect Scale Score

    Time frame: 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.

  11. Change in State-Trait Anxiety Inventory Form X

    Time frame: Baseline through month 24

    Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher state anxiety.

  12. Change in State-Trait Anxiety Inventory Form Y

    Time frame: Baseline through month 24

    Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher trait anxiety.

Secondary outcomes

  1. Rate of smoking reduction over time

    Time frame: Baseline through month 24

    Change in the number of self-reported daily cigarettes smoked at follow-ups will be examined.

  2. Change in PROMIS SF v1.0 Physical Function 4a short form

    Time frame: 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.

  3. Change in PROMIS SF v1.0 Anxiety 4a short form

    Time frame: 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.

  4. Change in PROMIS SF v1.0 Depression 4a short form

    Time frame: 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.

  5. Change in PROMIS SF v1.0 Fatigue 4a short form

    Time frame: 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.

  6. Change in PROMIS SF v1.0 Sleep Disturbance 4a short form

    Time frame: 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.

  7. Change in PROMIS SF v1.0 Ability to Participate in Social Roles and Activities 4a short form

    Time frame: 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.

  8. Change in Positive and Negative Affect Scale-Positive Affect Scale Score

    Time frame: 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.

  9. Change in Brief Cope Scale

    Time frame: Baseline through month 24

    Participant-reported outcome. Scores range from 2-8 and higher scores indicate greater ability to cope.

  10. Change in Pittsburgh Sleep Quality Index

    Time frame: Baseline through month 24

    Participant-reported outcome of change in sleep quality. Scores range from 0-21 and higher scores indicate worse sleep quality.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2019
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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