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RITCH: Reducing Disparities in Tobacco Cessation Outcomes

RITCH: Reducing Disparities in Tobacco Cessation Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02785536
Acronym
RITCh
Enrollment
256
Registered
2016-05-30
Start date
2013-07-31
Completion date
2015-06-30
Last updated
2016-07-01

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

Conditions

Smoking Cessation

Keywords

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

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.

Detailed description

This study will be conducted in five phases. Each phase utilizes the results from the previous phase. Each phase is also associated with at least one specific aim. Phase One (Aim One): Complete a revised version of a standard, widely utilized, multi-component, cognitive-behavior treatment manual for tobacco dependence to include commonly utilized, cognitive-behavioral interventions that specifically address the key factors associated with treatment outcome disparities. Phase Two (Aim Two): Using the PEN-3 Model,1-3 target and tailor RITCh\_1 to address the needs of smokers who are of lower SES as well as smokers who are minority, particularly African American. In this preparatory activity, the research team will tailor and target RITCh\_1 using this well-accepted theoretical model and produce the second draft of the revised treatment, called RITCh\_2. Human subjects are not involved with this phase of the research. No data will be collected. Phase Three (Aim Three): Pilot test RITCh\_2 with three treatment groups (5-10 participants per group) to assess understandability and acceptability and to ensure that it can be delivered in the same 60-minute per session time frame as the standard treatment. This is a qualitative study in which the investigators will pilot test RITCh\_2 with 21 participants who will be consented as pilot study participants. See Pilot Study Informed Consent Form. Contact and demographic information will be collected from participants, but not baseline and outcome assessments. Participant feedback will be provided in a group format and will not be linked to identifying information. The research team will incorporate participant feedback into a third draft of the revised treatment, RITCh\_3. Phase Four (Aim Four): Compare the effects of SES on treatment outcomes in a socioeconomically and racially diverse group of participants treated with RITCh\_3 and the standard treatment. The investigators will conduct a randomized controlled trial (n=253) comparing the efficacy of RITCh\_3 to the standard treatment. Investigators will use a randomized treatment design and two methods for assessing abstinence (latency to relapse and six-month point prevalence abstinence rates) to compare the effects of SES and treatment condition on treatment outcomes. Investigators expect RITCh\_3 to demonstrate fewer treatment outcome disparities than standard treatment. Phase Five (Aim Five): Compare the effects of RITCH\_3 and standard treatment on each of the key factors associated with treatment outcome disparities (see Aim One and Table 1). Using analysis of covariance and logistic regression as appropriate, investigators will analyze the effects of treatment condition on each of the key factors (see Table 1). The investigators expect participants treated with RITCh\_3 to demonstrate more improvement on each of the key factors than participants treated with standard treatment.

Interventions

BEHAVIORALRITCh Treatment

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.

BEHAVIORALStandard Treatment

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.

Sponsors

Virginia Tech Carilion School of Medicine and Research Institute
CollaboratorOTHER
The City College of New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Latency to Relapse6 months following scheduled week 3 quit dateAbstinence 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026