Smoking Cessation Program for Adults With Type 2 Diabetes Mellitus (DiMe-SALUD2 Project)
Trial Parameters
Brief Summary
The aim of this study is to analyze the effectiveness and efficiency of a multicomponent smoking cessation intervention for Type 2 Diabetes Mellitus (T2DM) smokers, including a training protocol on healthy lifestyle habits and self-management of T2DM called "DiMe-SALUD2" project. Overall, 90 patients will be randomly assigned to one of the following conditions: (1) Control Group (waiting list, n = 30), which will only receive brief psychoeducation advice about smoking cessation; (2) Experimental Group 1 - Cognitive-behavioral treatment (CBT) for smoking cessation (n = 30), where a multicomponent cognitive-behavioral program for quitting will be applied; (3) Experimental Group 2 - CBT for smoking cessation + DiMeSALUD2 protocol (n = 30), where the CBT intervention will be applied plus a training protocol on healthy lifestyle habits and self-management of T2DM. The specific goals of this project are: 1. To evaluate the added efficacy of the psychoeducation protocol on healthy lifestyle habits and self-management of T2DM plus the multicomponent cognitive-behavioral program to quit smoking (CBT for smoking cessation + DiMeSALUD2 protocol), compared to the standard application of this multicomponent program and to the control group. 2. To describe the impact of the CBT for smoking cessation + DiMeSALUD2 protocol on different key variables (explained below). 3. To analyze the efficiency or cost-effectiveness of the CBT for smoking cessation + DiMeSALUD2 program, and the feasibility of implementing this program in the public health system of Andalusia (Spain). 4. To transfer the knowledge generated to the main health professionals involved in the treatment of smokers with T2DM, through specialized training and the dissemination of a clinical manual created for this purpose.
Eligibility Criteria
Inclusion Criteria: * Being aged 18 or over. * Having smoked 10 or more cigarettes per day within the last year. * Meeting nicotine dependence criteria (Diagnostic and Statistical Manual of Mental Disorders, fifth Ed.; American Psychiatric Association, 2013). * Complying with baseline scores equal to or higher than 4 particles per million (ppm) of carbon monoxide (CO) levels in expired air and more than 80 ng/ml of cotinine levels in urine. * Having a diagnosis of T2DM and receiving routine medical treatment for this condition in their corresponding health services. * Participants who may present subclinical symptoms of both depression and anxiety will be included. * Participants who present comorbid physical problems such as cardiorespiratory problems will be included in the study, since smokers with T2DM have a higher incidence of such physical conditions. Exclusion Criteria: * Meeting comorbidity with severe psychological or psychiatric disorders, such as bipolar and related disorde