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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tara Mandel, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01399112
First received: July 27, 2010
Last updated: December 31, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Smoking
Psychosis
Behavioral: Web-based computer program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Usability Study of a Smoking Cessation Decision Aid in People With a Recent First Episode of Psychosis

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • number of cigarettes smoked [ Time Frame: One month ] [ Designated as safety issue: No ]
    Self-report of number of cigarettes smoked at baseline and at one month follow-up


Secondary Outcome Measures:
  • Satisfaction [ Time Frame: Immediately (up to 10 minutes) following the use of one of the web-based programs. ] [ Designated as safety issue: No ]
    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.


Enrollment: 11
Study Start Date: May 2010
Study Completion Date: March 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: EDSS

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399112

Locations
United States, New York
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Tara Mandel, Ph.D. North Shore Long Island Jewish Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Tara Mandel, Psychologist, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01399112     History of Changes
Other Study ID Numbers: EDSS
Study First Received: July 27, 2010
Last Updated: December 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Smoking Cessation
First episode psychosis
Electronic Decision Support System

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Smoking
Schizophrenia and Disorders with Psychotic Features
Habits

ClinicalTrials.gov processed this record on July 29, 2014