- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01982617
Motivational Interviewing Compared to Psychoeducation for Smoking Precontemplators With SMI
November 12, 2013 updated by: A. Eden Evins, Massachusetts General Hospital
A Randomized, Controlled Trial of Motivational Interviewing Compared to Psychoeducation for Smoking Precontemplators With Severe Mental Illness
The investigators primary hypothesis was that recipients of the Motivational Interviewing intervention would be significantly more likely than those assigned to the Psychoeducation intervention to demonstrate increased readiness to quit smoking at the end of the intervention and to seek smoking cessation treatment in the one month period following the intervention.
We also predicted that the Psychoeducation intervention would result in greater improvements in smoking knowledge.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford St
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-65 years of age
- Had a diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or chronic major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria
- Smoked at least 10 cigarettes per day
- At baseline, reported not being ready to quit smoking within the next 30 days (i.e., in precontemplation or contemplation stages).
Exclusion Criteria:
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motivational Interviewing
The Cognitive Behavioral Therapy/Motivational Interviewing group consisted of four group sessions focused on using motivational interviewing to enhance motivation to quit smoking and on presenting cognitive-behavioral techniques for preparing to cut down or quit smoking.
The following four topics were covered in this program: 1) Positive and Negative Aspects of Smoking, 2) Concerns and Hopes about Cutting Down or Quitting, 3) Small Changes that Can Help You Get Motivated, and 4) Planning for the Future.
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Experimental: Psychoeducation
The education group also consisted of four group sessions that were co-led by a doctoral-level clinical psychologist and at bachelors-level research assistant.
However, the focus of the education group was to present factual information about health risks of smoking, benefits of quitting, pharmacological smoking cessation aides, and smoking cessation programs in the area.
The four group topics included: 1) Health Risks of Smoking, 2) Benefits of Quitting, 3) Nicotine Replacement Therapy and Bupropion (Zyban), and 4) Options for Treatment Programs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readiness to quit (Stage of Change)
Time Frame: 30 days
|
efficacy of a cognitive behavioral therapy/motivational (MI) interviewing intervention relative to a psychoeducational (ED) intervention in terms of promoting increased readiness to quit smoking among smokers with severe mental illness who were not ready to quit.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Knowledge
Time Frame: 30 days
|
Changes in smoking knowledge obtained through cognitive behavioral therapy/motivational (MI) interviewing intervention relative to a psychoeducational (ED) intervention
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
November 6, 2013
First Submitted That Met QC Criteria
November 12, 2013
First Posted (Estimate)
November 13, 2013
Study Record Updates
Last Update Posted (Estimate)
November 13, 2013
Last Update Submitted That Met QC Criteria
November 12, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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