Online Automated Self-Hypnosis Program

Not Applicable

Completed

• Conditions: Pain; Smoking; Stress
• Interventions: Behavioral: Automated Self-Hypnosis

• Registration Number: NCT03931772
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2017-09-05
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-30
• Primary Completion: 2022-02-25
• Study Completion: 2022-02-25
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Automated Self-Hypnosis Intervention for Pain Reduction	Automated Self-Hypnosis	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.
Automated Self-Hypnosis Intervention for Stress Reduction	Automated Self-Hypnosis	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.
Automated Self-Hypnosis Intervention for Smoking Cessation	Automated Self-Hypnosis	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.

Primary Outcome Measures

Name	Time	Method
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 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 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.
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 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.
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.
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 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 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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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 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 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.
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 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.

Trial Locations

Locations (2)

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

Dept. of Psychiatry, Stanford University; 🇺🇸 Stanford, California, United States