Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Current smokers must be over the age of 18,
- Must have a diagnosis of schizophrenia or schizoaffective disorder
- Must smoke at least 10 cigarettes per day
- Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22
Exclusion Criteria:
•Those unable to give informed consent.
Sites / Locations
- UMDNJ- Robert Wood Johnson Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motivational Interviewing
Psychoeducation
Arm Description
Motivational Interviewing
Psychoeducation
Outcomes
Primary Outcome Measures
Attendance at first smoking cessation session
Secondary Outcome Measures
Cigarettes per day
Full Information
NCT ID
NCT00500695
First Posted
July 12, 2007
Last Updated
July 13, 2017
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00500695
Brief Title
Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness
Official Title
Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project will assess the utility of a brief motivational intervention to engage smokers with schizophrenia in treatment for tobacco dependence treatment. It is hypothesized that a brief motivational intervention will be more effective in engaging smokers with schizophrenia to tobacco dependence treatment than an educational intervention. The educational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by teaching subjects about the negative effects of smoking and the success of tobacco dependence treatment. The motivational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by increasing subjects' motivation to change by presenting objective and personalized information regarding their smoking behaviors in a non-judgmental and supportive manner.
Detailed Description
See Brief Summary above.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Description
Motivational Interviewing
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Psychoeducation
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
Motivational Interviewing
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Psychoeducation
Primary Outcome Measure Information:
Title
Attendance at first smoking cessation session
Time Frame
one month
Secondary Outcome Measure Information:
Title
Cigarettes per day
Time Frame
1-Month Follow Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current smokers must be over the age of 18,
Must have a diagnosis of schizophrenia or schizoaffective disorder
Must smoke at least 10 cigarettes per day
Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22
Exclusion Criteria:
•Those unable to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc L. Steinberg, PH.D.
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMDNJ- Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
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Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness
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