Online Automated Self-Hypnosis Program

NCT03931772 | Completed

• 1 other identifier: 42124
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking; Pain; Stress

Outcome Measures

Primary Outcomes (12)

• Rate of Self-reported smoking cessation

  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.

  Baseline through month 24

• Change in Brief Pain Inventory-Pain Interference Score

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

  Baseline through month 24

• Change in Brief Pain Inventory-Pain Severity Score

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

  Baseline through month 24

• Change in McGill Pain Questionnaire

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

  Baseline through month 24

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

  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.

  Baseline through month 24

• Change in PROMIS Global Pain Intensity (Pain Intensity 1a)

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

  Baseline through month 24

• Change in Perceived Stress Scale

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

  Baseline through month 24

• Change in Stanford Acute Stress Reaction Questionnaire

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

  Baseline through month 24

• Change in Impact of Event Scale - Revised

  Participant-reported outcome evaluating subjective stress caused by traumatic events, where scores range from 0-88 and higher scores indicate higher subjective stress.

  Baseline through month 24

• Change in Positive and Negative Affect Scale-Negative Affect Scale Score

  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.

  Baseline through month 24

• Change in State-Trait Anxiety Inventory Form X

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

  Baseline through month 24

• Change in State-Trait Anxiety Inventory Form Y

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

  Baseline through month 24

Secondary Outcomes (10)

• Rate of smoking reduction over time

  Baseline through month 24

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

  Baseline through month 24

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

  Baseline through month 24

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

  Baseline through month 24

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

  Baseline through month 24

Study Arms (3)

Automated Self-Hypnosis Intervention for Smoking Cessation

EXPERIMENTAL

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.

Behavioral: Automated Self-Hypnosis

Automated Self-Hypnosis Intervention for Pain Reduction

EXPERIMENTAL

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.

Behavioral: Automated Self-Hypnosis

Automated Self-Hypnosis Intervention for Stress Reduction

EXPERIMENTAL

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.

Behavioral: Automated Self-Hypnosis

Interventions

Automated Self-Hypnosis BEHAVIORAL

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

Automated Self-Hypnosis Intervention for Pain Reduction; Automated Self-Hypnosis Intervention for Smoking Cessation; Automated Self-Hypnosis Intervention for Stress Reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford Medicine - Psychiatry and Behavioral Sciences

Palo Alto, California, 94304, United States

Location

Dept. of Psychiatry, Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Smoking; Pain

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Spiegel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jack, Lulu and Sam Willson Professor and Associate Chair of Psychiatry & Behavioral Sciences, Director Center on Stress and Health

Model Details: This is a pilot, open trial evaluating a novel automated hypnosis intervention for smoking cessation and pain and reduction

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 30, 2019
• Study Start: September 5, 2017
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)