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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399112
• Other study ID #: EDSS
• Status: Completed
• Phase: N/A
• First received: July 27, 2010
• Last updated: December 31, 2012
• Start date: May 2010
• Est. completion date: March 2011

Study information

• Verified date: December 2012
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Smoking

Intervention

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.

Locations

Country	Name	City	State
United States	Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of cigarettes smoked	Self-report of number of cigarettes smoked at baseline and at one month follow-up	One month	No
Secondary	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.	Immediately (up to 10 minutes) following the use of one of the web-based programs.	No

External Links

•   thetruth.com website used as active comparison for EDSS