Trial record 3 of 182 for:    Open Studies | "Young Adult"

Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01779440
First received: January 25, 2013
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

Up to 77% of young people with severe mental illnesses smoke, a rate that is up to five times higher than the rate of daily smoking in other young adults. Contrary to popular belief, smoking tobacco does not provide any benefit for mental illness symptom control. People with severe mental illnesses (SMI: schizophrenia and severe mood disorders) are dying, on average, 25 years earlier than those without SMI. Much of this early mortality is due to higher rates of heart and lung diseases, cancers, strokes, and diabetes.

Cessation of smoking in these transition-age young adults can prevent cancer and increase life expectancy to that of non-smokers. Combination treatments are effective in this group and therefore key to improving outcomes, but few SMI smokers use them despite their interest in quitting. Motivational interventions for cessation increase interest in quitting, but public mental health clinicians do not deliver them, in part due to economic reasons. Thus cost effective methods to deliver motivational interventions to engage young smokers with SMI into treatment are needed.

To address this gap, we have developed an electronic decision support system (EDSS) for smoking cessation that is specifically tailored for smokers with SMI, who tend to have cognitive deficits and limited computer experience. Similar to EDSSs developed for other health problems, this EDSS provides information and motivational exercises within an easy-to-use, web-based computer program that can be used with minimal or no staff assistance. Initial piloting of the EDSS in middle-aged SMI smokers showed excellent usability and promising efficacy. Pilot-testing among young patients suggested that the EDSS increased motivation to quit smoking and provided direction to adapt the format and content of the EDSS for young SMI smokers.

The purpose of this proposal is to further develop the motivational decision support system and to test its ability to motivate young smokers with SMI to quit smoking with cessation treatment.


Condition Intervention
Mental Illness
Tobacco Smoking
Young Adults
Behavioral: Electronic Decision Support System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Change in Smoking Cessation Treatment measured by the behavioral Checklist delivered at baseline and 14 weeks [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
    Assesses through self-report and clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.


Estimated Enrollment: 110
Study Start Date: January 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Electronic Decision Support System
The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment.
Behavioral: Electronic Decision Support System
Placebo Comparator: Control Computer Program
A computer program aimed to educate people about smoking cessation treatment.

Detailed Description:

The research will take place over 2 years at the Long Island Zucker Hillside Hospital system. In Year 1, we will adapt our electronic decision support system, a web-based motivational tool, for young smokers with severe mental illness. We will first identify beliefs of young smokers with severe mental illness that impede use of smoking cessation treatments. Then, the decision support system will be revised to change these beliefs, field-tested for usability, and improved as needed. In Year 2, we will conduct a randomized control trial of the newly revised version of the system among 60 young smokers with severe psychotic disorders.

In the controlled trial, participants will be assessed at baseline for mental health symptoms and smoking behavior and history, and then randomized to use the system or a computerized public health pamphlet (control condition) within two weeks. Participants will be assessed again at 14-week follow-up for clinician-confirmed initiation of smoking cessation treatment (main outcome), beliefs, and smoking characteristics. Analyses will assess whether use of the decision support system results in greater initiation of cessation treatment (main outcome), and changes in beliefs about treatment, than use of the control intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

English-speaking; non-pregnant/nursing; daily smokers; age 18-30; psychiatrically stable; in treatment in the Zucker Hillside Hospital system; diagnosed with SMI (schizophrenia, schizoaffective disorder, or mood disorder with psychotic features from medical chart); willing and able to give informed consent.

Exclusion Criteria:

(Phase 4 only): current (within the past month) use of evidence-based smoking cessation treatment (indicating the subject is already motivated), psychiatric instability (Modified Colorado Symptom Index score >45), current untreated substance use disorder (SUD)

  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: NCT01779440

Contacts
Contact: Allison Berest 718-470-8362

Locations
United States, New York
Zucker-Hillside Hospital Recruiting
Glen Oaks, New York, United States, 11004
Contact: Hara Stephanou    718-470-4184    hstephanou@nshs.edu   
Contact: May Han    718-470-4161    mhan1@nshs.edu   
Principal Investigator: Delbert Robinson, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Mary F. Brunette, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01779440     History of Changes
Other Study ID Numbers: R21 CA158863-01A1, R21CA158863-01A1
Study First Received: January 25, 2013
Last Updated: February 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Dartmouth-Hitchcock Medical Center:
Mental Illness
Tobacco Smoking
Young Adults
Treatment Engagement
Motivational Intervention

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014