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Efficacy of Smoking Cessation Treatment Interventions for Individuals with Severe Mental Illness

Efficacy of Smoking Cessation Treatment Interventions for Individuals with Severe Mental Illness: A Pilot Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11353250
Enrollment
60
Registered
2015-03-04
Start date
2012-01-25
Completion date
Unknown
Last updated
2015-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco addiction in individuals with severe mental illness Mental and Behavioural Disorders Severe mental illness

Interventions

Clients randomly assigned to the SC-R group were offered twenty-four weeks of no cost NRT and clients assigned to the SC+ group were offered twenty-four weeks of no cost NRT plus two initial individua

Sponsors

University of Ottawa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants in the study were recruited from the client pool of a community mental health agency with an annual client census of over 1,200 individuals located in a large urban setting. Clients of the agency are adult men and women over sixteen years of age with a severe mental illness who, upon referral to the agency, are homeless or vulnerably housed. Eligibility for the study: 1. Adult men or women with severe mental illness 2. Over the age of 16 3. Smoke 5 or more cigarettes a day 4. Have identified an interest to reduce or eliminate tobacco use

Exclusion criteria

Exclusion criteria: As there is no adequate clinical research in pregnant women and smoking cessation treatments, women of childbearing age had a pregnancy test done to ensure that they were not pregnant before the study began. For women using medications to quit smoking, if they were pregnant or became pregnant during the study, these risks could affect their health or the unborn child. Therefore, women who were pregnant, breast-feeding or were planning a pregnancy within the next year would have been excluded from the study. In discussions with the study Nurse Practitioner, additional pregnancy tests were done during the study as needed.

Design outcomes

Primary

MeasureTime frame
Types of comparisons. Client outcomes in the SC-R treatment group were compared with the client outcomes in the SC+ treatment group. The smoking status outcome and levels of nicotine dependency of both groups were compared to the standard care group in order to provide a comparison group of individuals who did not receive the smoking cessation treatment in this program. Types of outcomes. Treatment outcomes were monitored at three months and at six months during interviews with the research staff and during weekly monitoring contacts with the nursing staff. Baseline interviews (n=62) were conducted in February, March, and April, 2012. The primary treatment outcomes related to tobacco use were continuous abstinence of tobacco from quit day and the overall reduction of tobacco use at three months and six months (or end of the study period). These outcomes were evaluated on an intent-to-treat (ITT) basis, in that any client whose smoking status could not be verified was considered to be smoking. Client tobacco use was monitored through self-report and through regular monitoring of expired breath carbon monoxide (CO) levels taken during their weekly meetings with the nursing staff. Clients were considered non smoking through self-report of their non smoking status to the nurse and with a verified expired breath carbon monoxide level of 5 ppm or less.

Secondary

MeasureTime frame
The secondary outcomes monitored included drug and alcohol use, quality of life, hospitalization, physical health functioning, mental health functioning, and housing status. A variety of data sources and methods of data collection were utilized. Baseline interviews were conducted in February, March, and April, 2012. The interim 3 month follow-up interviews were conducted in July and August, 2012 and the final 6 month follow-up interviews were conducted between September and November, 2012. Quantitative data was collected utilizing a combination of clinician rating and self-report measures that have been commonly used in community mental health research and that have good psychometric properties: Fagerström Test for Nicotine Dependence, Multnomah Community Ability Scale. Global Assessment of Individuals Needs Substance Use Problem Scale, The Short Form-36 Health Survey (SF-36), The Colorado Symptom Index (CSI), Quality of Life Inventory-20 Item (QoLI-20)

Countries

Canada

Contacts

Public ContactDonna Pettey
dlpettey@cmhaottawa.ca+1 (0)613 737 7791 ext. 121

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026