Nicotine DependenceNCT01982617
Motivational Interviewing Compared to Psychoeducation for Smoking Precontemplators With SMI
A study testing Motivational Interviewing and Psychoeducation in people with Nicotine Dependence, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Motivational Interviewing and Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford St
Boston, Massachusetts, 02114
About this study
Official title: 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.
- Conditions
- Nicotine Dependence
- Being tested
- Motivational Interviewing, Psychoeducation
- Keywords
- Transtheoretical Model, Stages of Change, Nicotine Dependence, Severe Mental Illness
- Medical subject headings
- Tobacco Use Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingOther
PsychoeducationOther
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | 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. Receives: Other: Motivational Interviewing |
| Psychoeducation | Experimental | 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. Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness to quit (Stage of Change)
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.
Measured: 30 days
Secondary outcomes (1)
Smoking Knowledge
Changes in smoking knowledge obtained through cognitive behavioral therapy/motivational (MI) interviewing intervention relative to a psychoeducational (ED) intervention
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startJan 2003
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Eden Evins, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982617
- Sponsor's protocol ID
- P2006
- Status last verified
- Nov 2013
- First submitted
- 6 Nov 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Motivational Interviewing Compared to Psychoeducation for Smoking Precontemplators With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT01982617
- Acronym / sponsor ID
- P2006
- Conditions
- Nicotine Dependence
- Keywords
- Transtheoretical Model, Stages of Change, Nicotine Dependence, Severe Mental Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Other: Motivational InterviewingThe 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. |
| Psychoeducation | Experimental | Other: PsychoeducationThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing | Other | Motivational Interviewing |
| Psychoeducation | Other | Psychoeducation |
Primary outcome
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.
1 secondary outcome
Smoking Knowledge
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Psychoeducation in people with Nicotine Dependence, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness to quit (Stage of Change) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.