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

NCT01779440 | Completed Results DMC

• 1 other identifier: R21CA158863-01A1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

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.

Conditions

Mental Illness; Tobacco Smoking; Psychotic Disorders

Keywords

Mental Illness; Tobacco Smoking; Young Adults; Treatment Engagement; Motivational Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  14 week follow-up

Secondary Outcomes (1)

• Number of Participants With Biologically Confirmed Abstinence

  14 weeks

Study Arms (2)

Electronic Decision Support System

OTHER

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

Control Computer Program

PLACEBO COMPARATOR

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

Behavioral: Electronic Decision Support System

Interventions

Electronic Decision Support System BEHAVIORAL

Control Computer Program; Electronic Decision Support System

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• (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)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03103, United States

Location

Greater Nashua Mental Health Center

Nashua, New Hampshire, 03060, United States

Location

Zucker-Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Related Publications (2)

• 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.

  PMID: 29881770 BACKGROUND

• 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.

  PMID: 29059417 RESULT

MeSH Terms

Conditions

Mental Disorders; Tobacco Smoking; Psychotic Disorders

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Schizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

• Title: Mary F. Brunette, MD
• Organization: Dartmouth-Hitchcock

Mary.F.Brunette@hitchcock.org

603-229-5419

Study Officials

• Mary F. Brunette, MD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor MD

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2013
• Primary Completion: February 22, 2018
• Study Completion: February 22, 2018
• Last Updated: June 27, 2018
• Results First Posted: June 27, 2018

Record last verified: 2018-05

Locations

US (3)