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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Online Automated Self-Hypnosis Program

Clinicaltrials.gov identifier NCT03931772

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted April 30, 2019

Study Description

Brief summary:

After developing professional quality materials (audio) for an inexpensive automated self-hypnosis intervention program for treating smoking cessation, researchers aim to gain qualitative reviews of this program, and test its initial feasibility and effects on smoking cessation.

  • Condition or Disease:Smoking
    Smoking Cessation
    Nicotine Dependence
  • Intervention/Treatment: Behavioral: Automated Self-Hypnosis
  • Phase: N/A
Detailed Description

The investigators are interested in recruiting individuals who report that they smoke cigarettes daily, are motivated to make a serious attempt at quitting, and are willing to try to use the hypnosis intervention and provide feedback regarding their experience with the intervention. The intervention would be pre-recorded and programmed to be an interactive hypnotic tool. It will be delivered through Amazon's Alexa device. The participants will be provided with the Alexa Dot device if they already do not possess one. Alexa Dot is a device sold by Amazon and widely used by consumers. What will be specific to this pilot is the interactive nature of the program that has been developed using the "skills beta testing tool" by Amazon. Potential participants will be recruited through websites and social media such as Facebook, flyers and by study Investigator, Dr. David Spiegel (or a member of his staff) who will propose the possibility of participation in the pilot study to patients seen at the clinics who may be eligible; he will also invite his psychiatrist colleagues to do the same for their patients. If the patients indicate that they are interested, they will be contacted by a research coordinator who is a member of Dr. Spiegel's staff. The coordinator will provide them with information about the pilot study, answer their questions, and determine whether the patient is eligible for the study. Eligible participants will be 18 years or older, able to read and understand English, and have a desire to quit smoking. Once found eligible, participants will pay one visit to the lab for about 1 hour, where they will be guided through the online auditory intervention by Dr. Spiegel (or a member of his staff), undergo hypnotizability testing, and complete brief questionnaires. This will take approximately one hour and will take place at The Center on Stress and Health. After the lab visit participants will continue using the intervention at home as needed. Furthermore, participants will be taking an at-home 10-15 minute survey at baseline, and then 1, 3, 6, 12 and 24-month follow-ups

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 80 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: This is a pilot, open trial evaluating a novel automated hypnosis intervention for smoking cessation
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Pilot Study Evaluating the Feasibility and Effects of an Innovative Online Automated Hypnosis Intervention for Smoking Cessation
  • Actual Study Start Date: September 2017
  • Estimated Primary Completion Date: September 2019
  • Estimated Study Completion Date: September 2019
Arms and interventions
Arm Intervention/treatment
Other: Automated Self-Hypnosis Intervention
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 the Amazon Alexa device to take home (necessary for using the program). After the lab visit participants will continue using the intervention at home as needed (recommended every few hours or whenever they feel the urge to smoke). Furthermore, participants will be taking an at-home 15 minute survey at baseline, and then 1, 3, 6, 12 and 24 month follow-ups.
Behavioral: Automated Self-Hypnosis
Hypnosis is a very safe and validated mind-body technique for symptom management of various clinical problems. The intervention is designed by the protocol's principal investigator, Dr. David Spiegel.
Outcome Measures
  • Primary Outcome Measures: 1. Self-reported smoking cessation [ Time Frame: Measured at 1 month follow up ]
    Researchers will examine rates of self-reported abstinence at 1 month follow-up. 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 index 1-month abstinence.
  • Secondary Outcome Measures: 1. Rate of smoking reduction over time (for smoking resumers) [ Time Frame: 1, 3, 6, 12, and 24 month follow-up ]
    The question, "If you have resumed smoking, on average, how many cigarettes do you now smoke?" will be asked via online survey at 1, 3, 6, 12 and 24 months. Investigators will examine differences (i.e., rate of change) over the two-year follow-up period in the average number of cigarettes smoked daily.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- 18 years or older

- Able to read and understand English

- Desire to quit smoking (specifically, report a motivation of ≥ 5 out of 10 to quit
smoking on a 10-point Likert-type scale)

- Having access to wireless internet connection or mobile data

- Reporting being a daily smoker for at least one year, smoking an average ≥ 5
cigarettes per day

Exclusion Criteria:

- Meeting criteria for drug abuse of depressants, 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. Indicated by denial of question
pertaining to inpatient hospitalization

- Hearing impairment that would impede ability to listen the auditory intervention

- Major illnesses impacting the study results

- Currently taking Wellbutrin, Chantix, or other pharmacological smoking cessation aids
that could confound results of the study

Contacts and Locations
Contacts

Contact: Johnna L Medina, PhD 650-497-4489 hypnosisquitsmoking@stanford.edu

Contact: Bita Nouriani, MS Bita Nouriani treatmentdecisionstudy@stanford.edu

Locations

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

United States, California
Dept. of Psychiatry, Stanford University
Stanford

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: David Spiegel Stanford University

More Information
  • Responsible Party: Stanford University
  • ClinicalTrials.gov Identifier: NCT03931772 History of Changes
  • Other Study ID Numbers: 42124
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: April 30, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Tobacco Use Disorder