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

Primary Purpose

Mental Illness, Tobacco Smoking, Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Decision Support System
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Illness focused on measuring Mental Illness, Tobacco Smoking, Young Adults, Treatment Engagement, Motivational Intervention

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mental Health Center of Greater Manchester
  • Greater Nashua Mental Health Center
  • Zucker-Hillside Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Placebo Comparator

Arm Label

Electronic Decision Support System

Control Computer Program

Arm Description

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.

A computer program aimed to educate people about smoking cessation treatment.

Outcomes

Primary Outcome Measures

Number of Participants Who Utilized Smoking Cessation Treatment
Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.

Secondary Outcome Measures

Number of Participants With Biologically Confirmed Abstinence
Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide <9 ppm

Full Information

First Posted
January 25, 2013
Last Updated
May 30, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01779440
Brief Title
Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness
Official Title
Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
February 22, 2018 (Actual)
Study Completion Date
February 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness, Tobacco Smoking, Psychotic Disorders
Keywords
Mental Illness, Tobacco Smoking, Young Adults, Treatment Engagement, Motivational Intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electronic Decision Support System
Arm Type
Other
Arm Description
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.
Arm Title
Control Computer Program
Arm Type
Placebo Comparator
Arm Description
A computer program aimed to educate people about smoking cessation treatment.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Decision Support System
Primary Outcome Measure Information:
Title
Number of Participants Who Utilized Smoking Cessation Treatment
Description
Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.
Time Frame
14 week follow-up
Secondary Outcome Measure Information:
Title
Number of Participants With Biologically Confirmed Abstinence
Description
Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide <9 ppm
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary F. Brunette, MD
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Center of Greater Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States
Facility Name
Greater Nashua Mental Health Center
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Zucker-Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29881770
Citation
Brunette MF, Feiron JC, Aschbrenner K, Colctti D, Devitt T, Greene MA, Harrington A, MoHugo GC, Pratt S, Robinson D, Williams J, Xie H. Characteristics and Predictors of Intention to use Cessation Treatment among Smokers with Schizophrenia: Young Adults Compared to Older Adults. J Subst Abus Alcohol. 2017;5(1):1055. Epub 2017 Mar 23.
Results Reference
background
PubMed Identifier
29059417
Citation
Brunette MF, Ferron JC, Robinson D, Coletti D, Geiger P, Devitt T, Klodnick V, Gottlieb J, Xie H, Greene MA, Ziedonis D, Drake RE, McHugo GJ. Brief Web-Based Interventions for Young Adult Smokers With Severe Mental Illnesses: A Randomized, Controlled Pilot Study. Nicotine Tob Res. 2018 Sep 4;20(10):1206-1214. doi: 10.1093/ntr/ntx190.
Results Reference
result

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

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