RecruitingNot ApplicableNCT05885659

Smoking Cessation Program for Adults With Type 2 Diabetes Mellitus (DiMe-SALUD2 Project)

A Multicomponent Smoking Cessation Program for Adults With Type 2 Diabetes Mellitus: A Study Protocol of a Randomized Controlled Trial (DiMe-SALUD2 Project)

Sponsor

University of Seville

Enrollment

90 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Tobacco Use Disorder

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria6

Meeting comorbidity with severe psychological or psychiatric disorders, such as bipolar and related disorders, personality disorders, eating disorders (for example, anorexia or bulimia), any disorder included within the schizophrenia spectrum and substance use related disorders (that is, other than nicotine dependence).
Having a diagnosis of Diabetes Mellitus Type 1 (DMT1) or gestational diabetes.
Meeting comorbid physical or neurological problems impairing communication. Moreover, we will exclude those patients who do not know the Spanish language enough to hold a fluid conversation.
Meeting the criteria for any physical health condition whose medical treatment is incompatible or contraindicated for the development of the smoking cessation treatment.
Receiving other psychological or pharmacological treatment for smoking cessation at the time of recruitment.
Not being able to attend all treatment sessions.

Interventions

OTHERControl group (waiting list)

T2DM in the control group will receive brief psychoeducation advice about smoking cessation as well as a general smoking cessation brochure/ booklet. Participants assigned to this control group will participate in the scheduled assessments (pre- and post-treatment, 1-month, 6-months and 12-months follow-ups) but without receiving any of the intensive treatments previously described (CBT vs. CBT+DiME-SALUD2 protocol).

BEHAVIORALCognitive Behavioral Treatment (CBT) for smoking cessation

CBT for smoking cessation will be implemented in group-based sessions of four to six patients, once a week over an eight-week period (Becoña, 2007), and includes three different components: (1) Motivational interviewing to stop smoking; (2) Smoking cessation, focused on nicotine fading from the first to the fourth session; (3) Maintenance of abstinence and relapse prevention strategies from the fifth session onwards. This modality of treatment also includes the following components, among others: Therapeutic contract, self-monitoring and graphical representation of tobacco consumption, psychoeducation about tobacco and specific characteristics of smoking behavior, stimulus control, strategies for coping with nicotine withdrawal symptoms, physiological feedback of consumption (using CO and cotinine in urine levels), social reinforcement when meeting nicotine reduction and abstinence goals, training in alternative behaviors to consumption and strategies for the prevention of relapses.

BEHAVIORALCBT for smoking cessation + DiMeSALUD2 protocol

In this group, a training protocol on healthy lifestyle habits and self-management of T2DM will be carried out added to usual care (CBT for smoking cessation). CBT plus DiMe-SALUD2 protocol will be developed as in the precedent group, but with the addition of a psychoeducational protocol for monitoring nicotine fading and abstinence specifically designed to address the particular needs of T2DM smokers. The main components of this protocol will be focused on strengthening healthy lifestyle habits as well as structured around the following core elements: dietary control and healthy nutrition, physical exercise, and glycemic control through daily self-registration of both glycemic variability and nicotine fading or abstinence. If necessary, the therapist will adapt these guidelines according to the established medical advice that the smokers receive from their own endocrinologist, so that this program is developed in accordance with their usual medical care.