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

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.

Conditions

• Tobacco Use Disorder
• Diabetes Mellitus, Type 2

Interventions

OTHER

Control 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).

BEHAVIORAL

Cognitive 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.

BEHAVIORAL

CBT 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.

Sponsors & Collaborators

• Andalusian Plan for Research, Development, and Innovation

  collaborator UNKNOWN

• University of Seville

  lead OTHER

Principal Investigators

• Carla López Núñez, Ph.D · Personality, Assessment and Psychological Treatments, School of Psychology, University of Seville

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-01

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Spain

Study Locations