NCT02086162

Brief Summary

In this study we will definitively test the decision support system in a randomized controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders. The Specific Aims of the study are:

  1. 1.To determine whether use of the web-based decision support system leads to higher rates of initiation of smoking cessation treatment than use of a computerized educational pamphlet. We will also assess effectiveness on secondary outcomes, including smoking behavior, urges and outcome expectancies; level of dependence; intentions to quit and to use cessation treatment; and abstinence.
  2. 2.To assess whether cognitive ability moderates initiation of smoking cessation treatment. Since cognitive impairment impedes use of standard web-based interventions by this group, and cognitive impairments likely supersede other potential moderators (education and socioeconomic status), this aim will be key to determining the success of our intervention and will guide further revisions if they are needed.
  3. 3.To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months
  4. 4.We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.
  5. 5.We will determine whether baseline cognition (scale scores) is associated with 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 12, 2018

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

2.3 years

First QC Date

March 11, 2014

Results QC Date

July 25, 2018

Last Update Submit

November 3, 2018

Conditions

Schizophrenia

Keywords

SchizophreniaSmokingTobaccoMotivationCessation Treatment

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects That Initiated Cessation Treatment

    Cessation treatment initiation and engagement will be collected from clinician attendance sheets in the medical record and medical record review for prescriptions. Medication use will be confirmed with self-report of taking medication.

    6 months

Secondary Outcomes (2)

  • Number of Subjects With Confirmed Abstinence

    6 months

  • Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence

    6 months

Study Arms (2)

Behavioral intervention

EXPERIMENTAL

Web-based motivational decision support system

Behavioral: Web-based motivational decision support system

Educational intervention

ACTIVE COMPARATOR

Computerized version of the National Cancer Institute (NCI) Educational Pamphlet

Behavioral: NCI Education

Interventions

Web-based motivational decision support systemBEHAVIORAL
Behavioral intervention
NCI EducationBEHAVIORAL
Educational intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • DSM-IV-TR diagnosis psychotic disorder
  • in treatment at participating mental health center
  • current daily smoker
  • fluent in English
  • physically able to use computer
  • willing and able to give informed consent

You may not qualify if:

  • past 2 weeks use of evidence based cessation treatment
  • psychiatric instability
  • current alcohol or drug dependence
  • pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Thresholds

Chicago, Illinois, 60613, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01605, United States

Location

Rutgers-UNDMJ

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

  • Brunette MF, Ferron JC, McGurk SR, Williams JM, Harrington A, Devitt T, Xie H. Brief, Web-Based Interventions to Motivate Smokers With Schizophrenia: Randomized Trial. JMIR Ment Health. 2020 Feb 8;7(2):e16524. doi: 10.2196/16524.

    PMID: 32039811DERIVED

MeSH Terms

Conditions

SchizophreniaSmoking

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Results Point of Contact

Title
Dr. Mary F. Brunette
Organization
Dartmouth-Hitchcock
mary.f.brunette@hitchcock.org
603-229-5419

Study Officials

  • Mary F. Burnette, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 13, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 29, 2018

Results First Posted

October 12, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

De-identified research data files will be made available to all researchers in both the public and private sectors for potential statistical analyses or re-analyses in accordance with the NIH data Sharing Policy: http://grants.nih.gov/grants/policy/data sharing. Data will be available 2 years after data collection is completed, or after primary papers have been accepted for publication. Data will only be transferred to other researchers under a signed data sharing agreement. Materials and research data files will be made available, upon request, from the PI. These requests can be made via email (mary.f.brunette@dartmouth.edu).

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available for sharing after we complete our analyses, estimated to be in January 2020.
Access Criteria
Investigators wishing to access data will submit a request with an analysis plan, data management plan and data safety plan to the PI. A signed data sharing agreement will be developed prior to release of the data.

Locations

US(3)