Intervening to Promote Tobacco Cessation Following Psychiatric Hospitalization

NCT05672914 | Recruiting DMC

• 2 other identifiers: STUDY00002552RP220203
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Cigarette smoking is the leading cause of death and disability in the United States. People with psychiatric disorders consume almost half (44.3%) of all cigarettes smoked in the U.S. and have life spans more than 20 years shorter than the general population. Effective quit smoking treatments for people with psychiatric disorders are sorely needed. When patients are hospitalized for a psychiatric disorder, they are not allowed to smoke. This enforced period of no smoking creates what professionals call "a teachable moment". It provides an excellent opportunity to discuss the prospect of staying quit once the individual leaves the hospital. In ongoing research, the investigators have developed and tested a Sustained Care quit smoking intervention for smokers engaged in a psychiatric hospitalization. The intervention includes: 1) a professionally-led, motivational counseling session to encourage quitting smoking and increase awareness about available quit smoking resources, 2) a referral to the Texas Tobacco Quitline for phone-based, quit smoking counseling, and 3) an offer of 8 weeks of nicotine patches after leaving the hospital. Findings from a recently completed clinical trial provide strong support for this Sustained Care intervention. Aims in the current project are to develop and test a tablet computer-based, motivational counseling intervention that does not require a trained professional counselor. The goal is to conduct a clinical trial to demonstrate the effectiveness of this tablet-based, Sustained Care intervention for smokers engaged in psychiatric hospitalization. As before, the same quit smoking resources (Quitline and nicotine patches) will be provided upon hospital discharge. If successful, next steps will involve plans to implement this quit smoking intervention in psychiatric hospitals throughout Texas, in order to reduce the burden caused by tobacco-related cancers among the citizens of Texas.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Smoking cessation

  Binomial outcome of continued smoking abstinence vs. relapse modeled over time and controlling for gender and magnitude of initial nicotine dependence

  1, 3, and 6 months after hospital discharge

Secondary Outcomes (1)

• Number of quit attempts

  First month following hospital discharge

Study Arms (2)

Tablet-based Sustained Care

EXPERIMENTAL

Intervention to support sustained smoking cessation.

Behavioral: Tablet-based sustained care

Usual Care

NO INTERVENTION

Standard hospital care: : A brief (5-10 min.) tobacco education session from a hospital nurse, along with educational materials about quitting and a quitline brochure.

Interventions

Tablet-based sustained care BEHAVIORAL

A tablet-based motivational-interviewing intervention, tailored specifically to smokers with psychiatric disorders, to motivate the use of evidence-based tobacco treatment and cessation in cigarette smokers upon discharge from an inpatient psychiatric hospitalization. In addition, participants will receive standard hospital tobacco care (see Usual Care Arm).

Tablet-based Sustained Care

Eligibility Criteria

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

You may qualify if:

• Male or female patients above the age of 18 capable of providing informed consent
• Current smoker (at least 5 cigarettes/day when not hospitalized)
• Willing and able to provide informed consent, attend all study visits, and comply with the protocol

You may not qualify if:

• Mini-Mental State Examination (MMSE) score \< 24
• Current diagnosis of dementia or other cognitive impairment that would limit study participation
• Inability to provide consent for study participation due to his/her inability to demonstrate an understanding of study procedures
• Current diagnosis of a (non-nicotine) substance use disorder requiring detoxification
• No access to or inability to communicate by phone, or no stable mailing address
• Planned discharge to institutional care (e.g., nursing home, long-term rehabilitation, jail, etc.)
• Medical contraindication to nicotine patch use
• Currently pregnant or breastfeeding

Sponsors & Collaborators

• University of Texas at Austin: lead
• Ascension Seton Shoal Creek: collaborator
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (1)

Ascension Shoal Creek

Austin, Texas, 78731, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Richard Brown, Ph.D.

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Brown, Ph.D.

CONTACT

+1 512 232-6832; brown2@utexas.edu

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: Research Professor

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 5, 2023
• Study Start: August 10, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)