Online Automated Self-Hypnosis Program

NCT ID: NCT03931772

Last Updated: 2023-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-05

Study Completion Date

2022-02-25

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.

Conditions

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Smoking Pain Stress

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

This is a pilot, open trial evaluating a novel automated hypnosis intervention for smoking cessation and pain and reduction
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Automated Self-Hypnosis Intervention for Smoking Cessation

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.

Group Type EXPERIMENTAL

Automated Self-Hypnosis

Intervention Type BEHAVIORAL

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

Automated Self-Hypnosis Intervention for Pain Reduction

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.

Group Type EXPERIMENTAL

Automated Self-Hypnosis

Intervention Type BEHAVIORAL

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

Automated Self-Hypnosis Intervention for Stress Reduction

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.

Group Type EXPERIMENTAL

Automated Self-Hypnosis

Intervention Type BEHAVIORAL

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

Interventions

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Automated Self-Hypnosis

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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David Spiegel

Jack, Lulu and Sam Willson Professor and Associate Chair of Psychiatry & Behavioral Sciences, Director Center on Stress and Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Spiegel, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Medicine - Psychiatry and Behavioral Sciences

Palo Alto, California, United States

Site Status

Dept. of Psychiatry, Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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42124

Identifier Type: -

Identifier Source: org_study_id

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