RITCH: Reducing Disparities in Tobacco Cessation Outcomes

NCT02785536 | Completed

• 1 other identifier: #361627
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

Tobacco use is a leading contributor to racial and socioeconomic health disparities in the US primarily due to an unequal burden of tobacco-related disease from a disproportionate share of smokers in African American and lower socioeconomic (SES) groups. Unlike many other health risk behaviors, tobacco-related health disparities are increasing despite a large treatment network of free telephone and in-person counseling services, perhaps due to significant disparities in treatment outcomes. The goal of this project is to revise the standard treatment for tobacco dependence to address key factors associated with treatment outcome disparities and more fully meet the needs of lower SES and African American smokers thereby reducing socioeconomic disparities in tobacco dependence treatment outcomes, halting the alarming increase in tobacco-related health disparities, and reducing a leading cause of racial and socioeconomic health disparities in the US.

Conditions

Smoking Cessation

Keywords

minority health; social class; healthcare disparities; tobacco use disorder

Outcome Measures

Primary Outcomes (1)

• Latency to Relapse

  Abstinence will be assessed with latency to relapse (days from Quit Date to relapse or 7 consecutive days of smoking after a 24 hour quit attempt)

  6 months following scheduled week 3 quit date

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

The standard treatment was a well-established, manual-driven, multicomponent CBT for tobacco dependence that has been delivered in multiple modalities (i.e., group, individual, and telephone), used in numerous studies, and considered intensive, comprehensive, and consistent with the Public Health Service Clinical Practice Guideline.

Behavioral: Standard Treatment

RITCh Treatment

EXPERIMENTAL

The RITCh treatment is an adaptation of the standard treatment which proactively addresses the needs and experiences of a diverse group of lower SES smokers as well as ensures that the treatment is culturally congruent and experientially resonant for African Americans while maintaining the same amount of treatment contact (i.e., six one-hour sessions).

Behavioral: RITCh Treatment

Interventions

RITCh Treatment BEHAVIORAL

The RITCh treatment increased the emphasis on stress management, negative affect management and utilized language and activities to foster an internal locus of control. Activities were added to address impulsive decision-making, develop home smoking policies, increase the positive valance of treatment, and address barriers to use of the nicotine patches. The treatment materials were also tailored with numerous examples relevant to lower SES groups and African Americans. For example: stress management components specifically address financial stress, discrimination, and micro-aggressions; treatment utilization components include reinforcing the value of individual contributions to the group, structured positive feedback among group members at every session, sending "missed you" post cards signed by all group members to participants who miss a treatment session, specifically addressing myths about nicotine patch use, and practicing the application of nicotine patches together.

RITCh Treatment

Standard Treatment BEHAVIORAL

The components of the standard treatment include education and activities in which participants gain an understanding of the biopsychosocial underpinnings of tobacco dependence and the cue-urge-response cycle of smoking. Interventions include self-monitoring, guided scheduled rate reduction, treatment goal setting, medication education, stress management, cognitive and behavioral strategies for managing cravings and cues, problem-solving, conflict management, enhancing social support, relapse prevention, and cigarette refusal training. A participant workbook was provided that corresponded to the activities in the treatment sessions.

Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smoking cigarettes daily
• expressing a desire to quit smoking in the next 30 days
• no regular use of other tobacco products
• age 18 years or older
• no plans to move from the area in the next six months
• willing to comply with treatment
• able to engage in treatment

You may not qualify if:

• any contra-indication for use of the nicotine patch (i.e., uncontrolled high blood pressure, allergic reaction to patch adhesive, pregnancy, etc.),
• currently using mediations for smoking cessation (bupropion, varenicline, or any form of NRT)
• drinking more than 20 alcoholic drinks per week
• positive test on a urine screen for drugs of abuse at baseline (amphetamine, methamphetamine, cannabis, cocaine, opioids, methadone, etc.)
• current diagnosis that would prohibit engagement in brief CBT (active psychotic disorder, acute major depressive episode, significantly cognitively impaired)
• current regular use of other forms of tobacco other than smoking cigarettes

Sponsors & Collaborators

• The City College of New York: lead
• Virginia Tech Carilion School of Medicine and Research Institute: collaborator

Study Sites (1)

The City College of New York

New York, New York, 10031, United States

Location

Related Publications (1)

• Lunden SE, Pittman JC, Prashad N, Malhotra R, Sheffer CE. Cognitive, Behavioral, and Situational Influences on Relapse to Smoking After Group Treatment for Tobacco Dependence. Front Psychol. 2019 Jan 30;9:2756. doi: 10.3389/fpsyg.2018.02756. eCollection 2018.

  PMID: 30761059 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Christine E Sheffer, PhD

  CCNY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: May 30, 2016
• Study Start: July 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 1, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)