Online Automated Self-Hypnosis Program

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931772
• Other study ID #: 42124
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: February 25, 2022

Study information

• Verified date: March 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: February 25, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Smoking
• Stress

Intervention

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

Locations

Country	Name	City	State
United States	Stanford Medicine - Psychiatry and Behavioral Sciences	Palo Alto	California
United States	Dept. of Psychiatry, Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in Perceived Stress Scale	Participant-reported outcome. Scores range from 10-50; higher scores indicate higher stress.	Baseline through month 24
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Rate of smoking reduction over time	Change in the number of self-reported daily cigarettes smoked at follow-ups will be examined.	Baseline through month 24
Secondary	Change in PROMIS SF v1.0 Physical Function 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 physical function.	Baseline through month 24
Secondary	Change in PROMIS SF v1.0 Anxiety 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 anxiety.	Baseline through month 24
Secondary	Change in PROMIS SF v1.0 Depression 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 depression.	Baseline through month 24
Secondary	Change in PROMIS SF v1.0 Fatigue 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 fatigue.	Baseline through month 24
Secondary	Change in PROMIS SF v1.0 Sleep Disturbance 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 sleep disturbance.	Baseline through month 24
Secondary	Change in PROMIS SF v1.0 Ability to Participate in Social Roles and Activities 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 ability to participate in social roles and activities.	Baseline through month 24
Secondary	Change in Positive and Negative Affect Scale-Positive Affect Scale Score	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.	Baseline through month 24
Secondary	Change in Brief Cope Scale	Participant-reported outcome. Scores range from 2-8 and higher scores indicate greater ability to cope.	Baseline through month 24
Secondary	Change in Pittsburgh Sleep Quality Index	Participant-reported outcome of change in sleep quality. Scores range from 0-21 and higher scores indicate worse sleep quality.	Baseline through month 24