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A Usability Study of a Smoking Cessation Decision Aid in People With a Recent First Episode of Psychosis

Primary Purpose

Smoking, Psychosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based computer program
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Smoking focused on measuring Smoking Cessation, First episode psychosis, Electronic Decision Support System

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with clinical diagnoses of Schizophrenia, Schizophrenifom, Schizoaffective Disorder, Psychosis NOS, or Bipolar I Disorder with psychotic features
  • Diagnosed with one of above diagnoses within the past five years
  • Ages 15-30 years old.
  • Self-identified current cigarette smokers
  • 5th grade reading level
  • Willing to be audio recorded.
  • Willing and legally able to provide informed consent to participate in the study or have a guardian provide informed consent with assent of a minor

Exclusion Criteria:

  • Physically unable to use a computer with assistance.

Sites / Locations

  • Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electronic Decision Support System

thetruth.com website

Arm Description

The Electronic Decision Support System (EDSS) is a 5-module computer program aimed to assess, motivate, educate, solicit preferences, and provide feedback and referrals for people with severe mental illness. The program provides: a) a personalized assessment of the individual's smoking, b) information to improve knowledge of smoking risks and treatment benefits, c) interactive exercises to personalize the impact of smoking, improve attitudes about quitting, and increase self-efficacy for seeking smoking cessation treatment, and d) a video patient vignette to develop social norms for smoking cessation treatment and increase self-efficacy. Usability testing among people with severe mental illness established that the system was comprehensible, easy to use, and took 30-90 minutes to complete.

Participants who are assigned to use the web-based thetruth.com website will be asked to navigate through the website as they wish. The home page of thetruth.com site has links to access video games, fact sheets, and videos that highlight negative aspects of cigarettes or tobacco companies. Thetruth.com website is not structured and participants can utilize whatever aspects of the website they wish and in any order they wish to view them. Individuals will use the computer with a research staff member present who can provide assistance if needed. The sections of the two programs website that are used and the time spend on each portion of the program will be recorded. Participants who use TheTruth.com will be given a referral for assistance in quitting smoking if requested.

Outcomes

Primary Outcome Measures

number of cigarettes smoked
Self-report of number of cigarettes smoked at baseline and at one month follow-up

Secondary Outcome Measures

Satisfaction
Immediately after using the assigned web-based program, the participant will be asked a series of questions regarding what they liked, did not like, found easy to use or found difficult to use when engaging with the computer program. These questions take approximately 5-10 minutes to answer.

Full Information

First Posted
July 27, 2010
Last Updated
December 31, 2012
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT01399112
Brief Title
A Usability Study of a Smoking Cessation Decision Aid in People With a Recent First Episode of Psychosis
Official Title
A Usability Study of a Smoking Cessation Decision Aid in People With a Recent First Episode of Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators propose to recruit patients who have experienced a recent first episode of psychosis who have a chart diagnosis of Schizophrenia, Schizophrenifom, Schizoaffective Disorder, Psychosis NOS, or Bipolar I Disorder with psychotic features and self identify themselves as a current cigarette smoker. Aiding this population with smoking cessation is crucial as the majority of people with schizophrenia spectrum disorders (50-90%) smoke, which is leading to early mortality. While these individuals can benefit from standard evidence-based treatment, these treatments are underutilized. Web based programs, such as the EDSS and thetruth.com, can provide education and motivational tools to help people with a recent onset of psychosis use evidence-based smoking cessation treatments. This study aims to test these two web-based programs among young people with a recent episode of psychosis for usability and likeability and to explore whether use of these two programs will motivate users to seek smoking cessation treatment or to engage in other quitting behaviors in the month following use of the programs. Information gathered from this proposal will be used to help the researchers decide whether either of these two programs will be reasonable to include in a larger study of a comprehensive treatment for individuals with first episode psychosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Psychosis
Keywords
Smoking Cessation, First episode psychosis, Electronic Decision Support System

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electronic Decision Support System
Arm Type
Experimental
Arm Description
The Electronic Decision Support System (EDSS) is a 5-module computer program aimed to assess, motivate, educate, solicit preferences, and provide feedback and referrals for people with severe mental illness. The program provides: a) a personalized assessment of the individual's smoking, b) information to improve knowledge of smoking risks and treatment benefits, c) interactive exercises to personalize the impact of smoking, improve attitudes about quitting, and increase self-efficacy for seeking smoking cessation treatment, and d) a video patient vignette to develop social norms for smoking cessation treatment and increase self-efficacy. Usability testing among people with severe mental illness established that the system was comprehensible, easy to use, and took 30-90 minutes to complete.
Arm Title
thetruth.com website
Arm Type
Active Comparator
Arm Description
Participants who are assigned to use the web-based thetruth.com website will be asked to navigate through the website as they wish. The home page of thetruth.com site has links to access video games, fact sheets, and videos that highlight negative aspects of cigarettes or tobacco companies. Thetruth.com website is not structured and participants can utilize whatever aspects of the website they wish and in any order they wish to view them. Individuals will use the computer with a research staff member present who can provide assistance if needed. The sections of the two programs website that are used and the time spend on each portion of the program will be recorded. Participants who use TheTruth.com will be given a referral for assistance in quitting smoking if requested.
Intervention Type
Behavioral
Intervention Name(s)
Web-based computer program
Other Intervention Name(s)
EDSS
Intervention Description
Web-based computer programs will be used to help education people with a recent first episode of a mental illness learn about smoking. The programs are designed to help young smokers become motivated to being a smoking cessation program.
Primary Outcome Measure Information:
Title
number of cigarettes smoked
Description
Self-report of number of cigarettes smoked at baseline and at one month follow-up
Time Frame
One month
Secondary Outcome Measure Information:
Title
Satisfaction
Description
Immediately after using the assigned web-based program, the participant will be asked a series of questions regarding what they liked, did not like, found easy to use or found difficult to use when engaging with the computer program. These questions take approximately 5-10 minutes to answer.
Time Frame
Immediately (up to 10 minutes) following the use of one of the web-based programs.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with clinical diagnoses of Schizophrenia, Schizophrenifom, Schizoaffective Disorder, Psychosis NOS, or Bipolar I Disorder with psychotic features Diagnosed with one of above diagnoses within the past five years Ages 15-30 years old. Self-identified current cigarette smokers 5th grade reading level Willing to be audio recorded. Willing and legally able to provide informed consent to participate in the study or have a guardian provide informed consent with assent of a minor Exclusion Criteria: Physically unable to use a computer with assistance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Mandel, Ph.D.
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.thetruth.com
Description
thetruth.com website used as active comparison for EDSS

Learn more about this trial

A Usability Study of a Smoking Cessation Decision Aid in People With a Recent First Episode of Psychosis

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