RITCH: Reducing Disparities in Tobacco Cessation Outcomes
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/2/2016 |
| Start Date: | July 2013 |
| End Date: | June 2015 |
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.
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.
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.
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.
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
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