NCT01982617

Brief 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 the one month period following the intervention. We also predicted that the Psychoeducation intervention would result in greater improvements in smoking knowledge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

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

January 1, 2003

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

10 years

First QC Date

November 6, 2013

Last Update Submit

November 12, 2013

Conditions

Keywords

Transtheoretical ModelStages of ChangeNicotine DependenceSevere Mental Illness

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days

Secondary Outcomes (1)

  • Smoking Knowledge

    30 days

Study Arms (2)

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.

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.

Other: Psychoeducation

Interventions

Motivational Interviewing
Psychoeducation

Eligibility Criteria

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

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford St

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderMental Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Addiction Medicine

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 13, 2013

Study Start

January 1, 2003

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations