An interventional study of Acceptance and Commitment Therapy and Standard smoking cessation intervention in Smoking and Type 2 Diabetes, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-04-12.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Treatment
This study is designed to develop and test a smoking cessation intervention for smokers with Type 2 diabetes.
Individuals with Type 2 diabetes smoke at rates similar to those found in the general population, and the health consequences of smoking are particularly severe among smokers with diabetes. In fact, there appears to be a synergistic effect between smoking and diabetes on mortality. However, despite reports that highlight the importance of this work, a paucity of studies have been conducted to develop and test smoking cessation interventions tailored to meet the needs of individuals with diabetes. The small number of extant studies have yielded mixed results. Distress tolerance (DT) focused, acceptance-based interventions have demonstrated efficacy for smoking cessation, and there is increasing support for the conceptual model underlying these interventions among individuals with diabetes. The long-term objective of this research program is to improve smoking cessation treatment for individuals with Type 2 diabetes by developing and establishing the efficacy of a DT smoking cessation intervention tailored to this population. Furthermore, we seek to advance knowledge of the relationships among nicotine withdrawal, negative affect, distress tolerance, and smoking cessation outcomes among individuals with diabetes.
In the present study, we will develop a DT intervention tailored to meet the needs of smokers with Type 2 diabetes. In the first phase of this project, we will develop and pilot the intervention with 18 patients. In the second phase of the project, we will conduct a preliminary, randomized trial with 54 patients to examine the efficacy of the DT intervention relative to a standard smoking cessation treatment (ST) that equates for therapist contact time. Patients in both conditions will receive the transdermal nicotine patch.
We expect that, relative to the ST condition, patients randomized to the DT condition will have increased likelihood of smoking abstinence and increased latency to both smoking lapse and relapse. If the efficacy of this intervention can be established in this trial and in subsequent large scale randomized controlled trials, smokers with diabetes will have improved smoking cessation treatment options. The need for this work is great given the paucity of extant work in this area, the significantly heightened risk of morbidity and mortality from smoking among diabetic patients, the rapidly increasing rate of diabetes in the U.S., and an apparent stabilization of the smoking rate in recent years.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
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Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
Acceptance and Commitment Therapy based Distress Tolerance (DT) smoking cessation intervention delivered in 7 2-hour group, 1 50-minute individual, and 2 10-minute phone sessions and 8 weeks of transdermal nicotine patch.
Behavioral: Acceptance and Commitment Therapy
Standard smoking cessation intervention delivered in 7 2-hour group, 1 50-minute individual, and 2 10-minute phone sessions and 8 weeks of transdermal nicotine patch.
Behavioral: Standard smoking cessation intervention
The intervention is based on Acceptance and Commitment Therapy and will be tailored to smokers with Type 2 diabetes.
Standard smoking cessation intervention based on clinical practice guidelines.
Point prevalence abstinence from smoking
We will compare the percentage of participants in each treatment condition who report abstinence from smoking for the 7 days preceding the assessment.
Time frame: 26 weeks from smoking quit date
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Rhode Island Hospital