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

NARecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Tobacco Use DisorderDiabetes 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.

Trial Locations (1)

41018

RECRUITING

Carla López Núñez, Seville

All Listed Sponsors
collaborator

Andalusian Plan for Research, Development, and Innovation

UNKNOWN

lead

University of Seville

OTHER