An Integrated Approach to Smoking Cessation in Severe Mental Illness (SMI)

NCT00690131 | Completed DMC

• 2 other identifiers: HP-000431211R34MH080814-01A1
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 3

Brief Summary

This 3-year study will involve the design and small-scale clinical trial of a behavioral treatment program for smoking cessation in people with severe mental illness (called Behavioral Treatment for Smoking Cessation in Serious and Persistent Mental Illness or BTSCS) in two psychosocial rehabilitation programs (PRPs) in Baltimore. Our aims are: (1) Develop intervention materials and examine feasibility, acceptability, and safety; (2) Measure the effects of the intervention at post-treatment and 3-month follow-up on rates of smoking cessation, number of quit attempts, rates of smoking reduction and intention/motivation to quit smoking.

Conditions

Smoking Cessation

Keywords

Smoking cessation, severe mental illness, behavioral treatment

Outcome Measures

Primary Outcomes (3)

• Smoking abstinence: percentage of participants reporting abstinence reported in the 7-day interval at post-treatment and follow-up

  7-day interval at post-treatment and follow-up

• Smoking abstinence: average percentage of biweekly sessions with negative expired carbon monoxide (CO) levels (< 8 ppm)

  from baseline to post treatment

• Number of smoking quit attempts: self-reported number of quit attempts (for at least 24 hours) at post treatment and 3 month follow-up

  time from baseline to post treatment and baseline to 3 month follow-up

Study Arms (2)

1

EXPERIMENTAL

Behavioral: BTSCS

2

NO INTERVENTION

Interventions

BTSCS BEHAVIORAL

BTSCS includes: (1) A behavioral group emphasizing motivational enhancement, skills training, education, and relapse prevention; (2) Contingency management with financial incentives to reinforce reductions in smoking; (3) Supported use of Bupropion or nicotine replacement therapy that is integrated with clients' psychiatric care in participants who are interested; and (4) Smoking cessation care coordination to increase treatment engagement and retention.

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe and Persistent Mental Illness (schizophrenia, schizoaffective disorder or other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder).
• Age between 18 and 75 years.
• Current smokers who smoke at least 10 cigarettes per day.
• Must have been seen by a psychiatrist at least every 3 months for the last 6 months.

You may not qualify if:

• Meet criteria for current alcohol/substance dependence (other than nicotine).
• Documented mental retardation, history of severe head injury with LOC, severe and untreated seizure disorder

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Harbor City Unlimited

Baltimore, Maryland, United States

Location

New Ventures, Sheppard Pratt

Timonium, Maryland, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Mental Disorders

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Melanie E Bennett, Ph.D.

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 4, 2008
• Study Start: August 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

US (3)