Clinical trial NCT03931772: Online Automated Self-Hypnosis Program
Official title: Pilot Study Evaluating the Feasibility and Effects of an Innovative Automated Hypnosis Intervention for Smoking Cessation and Pain and Stress Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Pain
Stress
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot, open trial evaluating a novel automated hypnosis intervention for smoking cessation and pain and reduction
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Self-reported smoking cessation
timeFrame: Baseline through month 24
measure: Change in Brief Pain Inventory-Pain Interference Score
timeFrame: Baseline through month 24
measure: Change in Brief Pain Inventory-Pain Severity Score
timeFrame: Baseline through month 24
measure: Change in McGill Pain Questionnaire
timeFrame: Baseline through month 24
measure: Change in PROMIS SF v1.0 Pain Interference 4a short form
timeFrame: Baseline through month 24
measure: Change in PROMIS Global Pain Intensity (Pain Intensity 1a)
timeFrame: Baseline through month 24
measure: Change in Perceived Stress Scale
timeFrame: Baseline through month 24
measure: Change in Stanford Acute Stress Reaction Questionnaire
timeFrame: Baseline through month 24
measure: Change in Impact of Event Scale - Revised
timeFrame: Baseline through month 24
measure: Change in Positive and Negative Affect Scale-Negative Affect Scale Score
timeFrame: Baseline through month 24
measure: Change in State-Trait Anxiety Inventory Form X
timeFrame: Baseline through month 24
measure: Change in State-Trait Anxiety Inventory Form Y
timeFrame: Baseline through month 24
Secondary outcomes:
measure: Rate of smoking reduction over time
timeFrame: Baseline through month 24
measure: Change in PROMIS SF v1.0 Physical Function 4a short form
timeFrame: Baseline through month 24
measure: Change in PROMIS SF v1.0 Anxiety 4a short form
timeFrame: Baseline through month 24
measure: Change in PROMIS SF v1.0 Depression 4a short form
timeFrame: Baseline through month 24
measure: Change in PROMIS SF v1.0 Fatigue 4a short form
timeFrame: Baseline through month 24
measure: Change in PROMIS SF v1.0 Sleep Disturbance 4a short form
timeFrame: Baseline through month 24
measure: Change in PROMIS SF v1.0 Ability to Participate in Social Roles and Activities 4a short form
timeFrame: Baseline through month 24
measure: Change in Positive and Negative Affect Scale-Positive Affect Scale Score
timeFrame: Baseline through month 24
measure: Change in Brief Cope Scale
timeFrame: Baseline through month 24
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: Baseline through month 24
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Medicine - Psychiatry and Behavioral Sciences
state: California
city: Stanford
country: United States
facility: Dept. of Psychiatry, Stanford University
state: California
Study officials:
affiliation: Stanford University
name: David Spiegel, MD
role: PRINCIPAL_INVESTIGATOR
References: