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

December 31, 2012 updated by: Tara Mandel, Northwell Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Glen Oaks, New York, United States, 11004
        • Zucker Hillside Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electronic Decision Support System
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.
Behavioral: Web-based computer program
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.
Other Names:
  • EDSS
Active Comparator: thetruth.com website

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.
Behavioral: Web-based computer program
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.
Other Names:
  • EDSS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of cigarettes smoked
Time Frame: One month
Self-report of number of cigarettes smoked at baseline and at one month follow-up
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction
Time Frame: Immediately (up to 10 minutes) following the use of one of the web-based programs.
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.
Immediately (up to 10 minutes) following the use of one of the web-based programs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Tara Mandel, Ph.D., Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 20, 2011

First Posted (Estimate)

July 21, 2011

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

December 31, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDSS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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