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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01982617
Other study ID # P2006
Secondary ID
Status Completed
Phase N/A
First received November 6, 2013
Last updated November 12, 2013
Start date January 2003
Est. completion date January 2013

Study information

Verified date November 2013
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

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


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
Motivational Interviewing

Psychoeducation


Locations

Country Name City State
United States Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford St Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Smoking Knowledge Changes in smoking knowledge obtained through cognitive behavioral therapy/motivational (MI) interviewing intervention relative to a psychoeducational (ED) intervention 30 days No
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