Phase 3
Completed N=179
Smoking Cessation for Veterans With Severe and Persistent Mental Illness
schizoaffective disorder · Schizophrenia · Affective Psychosis, Bipolar · Affective Disorders, Psychotic
Source: ClinicalTrials.gov NCT00960375 ↗
Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Number of Cigarettes Smoked Per Day — 15.4; 14.9 number of cigarettes — p=0.489
Summary
The investigators have developed an intervention called Behavioral Treatment of Smoking Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and education with contingency management and a multifaceted behavioral group treatment program that lasts for three months (24 group meetings). BTSCS is designed to address the cognitive, motivational, and social support problems characteristic of people with SPMI.
The investigators propose to conduct a randomized trial for persons with SPMI that compares (1) BTSCS: a 6-month manualized smoking cessation program adapted from an effective substance abuse treatment program for this population to (2) StSST: a standard manualized smoking cessation program which reflects current best practices.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Cigarettes Smoked Per Day |
15.4; 14.9 | 0.489 |
| PRIMARY Abstinence From Tobacco |
10; 6 | 0.685 |
Eligibility Criteria
Inclusion Criteria
- DSM-IV diagnosis of severe and persistent mental illness (SPMI) including a diagnosis of a psychotic disorder in keeping with criteria established by the Serious Mental Illness Treatment Research and Evaluation Center (SMITREC) -Schizophrenic disorders, affective psychoses and other psychotic diagnoses. We also include individuals with a diagnosis of Major Depression with psychotic features and PTSD.
- Age 18-75
- Nicotine dependence as defined by a score of 5 or higher on the Fagerstrom Tolerance Scale OR Participants who currently smoke at least 10 cigarettes per day
- Participants will not meet criteria for current alcohol/substance dependence (other than nicotine)
- Willingness ability to provide consent to participate.
Exclusion Criteria
- Documented history of severe neurological disorder or severe head trauma with loss of consciousness
- Severe or profound mental retardation by chart review.
Data sourced from ClinicalTrials.gov (NCT00960375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.