NCT00500695

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started May 2006

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

7.4 years

First QC Date

July 12, 2007

Last Update Submit

July 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Attendance at first smoking cessation session

    one month

Secondary Outcomes (1)

  • Cigarettes per day

    1-Month Follow Up

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

Motivational Interviewing

Behavioral: Motivational Interviewing

Psychoeducation

ACTIVE COMPARATOR

Psychoeducation

Behavioral: Psychoeducation

Interventions

Motivational Interviewing

Motivational Interviewing
PsychoeducationBEHAVIORAL

Psychoeducation

Psychoeducation

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Those unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMDNJ- Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Marc L. Steinberg, PH.D.

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 13, 2007

Study Start

May 1, 2006

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations