Clinical trial NCT05885659: Smoking Cessation Program for Adults With Type 2 Diabetes Mellitus (DiMe-SALUD2 Project)
Official title: A Multicomponent Smoking Cessation Program for Adults With Type 2 Diabetes Mellitus: A Study Protocol of a Randomized Controlled Trial (DiMe-SALUD2 Project)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Disorder
Diabetes Mellitus, Type 2
Keywords: Smoking cessation
Tobacco Use Disorder
Type 2 Diabetes Mellitus
Randomized controlled trial
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Andalusian Plan for Research, Development, and Innovation
First posted: 2023-06-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of three groups (Control Group, Experimental Group 1, Experimental Group 2). A member of the research team who will not be directly involved in the trial (i.e., development of the assessments and treatment sessions) will create a simple computer-generated randomization sequence using Research Randomizer software (version 4.0, Urbaniak GC and Plous S, Middletown, CT, USA; http://www.randomizer.org).
Primary purpose: TREATMENT

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.

Detailed description: Despite the fact that there are effective psychological treatments for smoking cessation, studies report that a high percentage of attempts to quit smoking fail and relapse rates after a period of abstinence continue to be high. Thus, it is necessary to incorporate new smoking abstinence and relapse prevention strategies in those treatments implemented with treatment-seeking smokers.

A possible solution to tackle this health problem would be to consider the particular needs of smokers, especially those who have other related pathologies. That is, smoking cessation programs have traditionally been applied to the general population, but there are fewer smoking cessation treatments adapted to the differentiating characteristics of specific groups of the population, especially those who have some type of concurrent physical illness, such as the case of patients with Type 2 Diabetes Mellitus (T2DM). In this sense, smoking behavior is not only related to the etiology of diabetes, but tobacco consumption exerts a harmful effect on these patients, accelerating chronic complications and increasing the risk of mortality.

This study will be conducted through a prospective cohort randomized controlled trial, which will include 90 patients randomly assigned to different conditions:

1. Control Group or waiting list (n = 30), which will only receive brief psychoeducation advice about smoking cessation (that is, participants assigned to this control group will participate in the scheduled assessments but without receiving any of the intensive treatments including in the remaining conditions).
2. Experimental Group 1 - CBT for smoking cessation (n = 30), where a cognitive-behavioral multicomponent program will be implemented in group-based sessions of four to six patients, once a week over an eight-week period.
3. Experimental Group 2 - CBT for smoking cessation + DiMeSALUD2 protocol (n = 30), where the cognitive-behavioral multicomponent program will be applied but adding a specific training protocol on healthy lifestyle habits and self-management of T2DM. The main components of this protocol will be focused on strengthening healthy lifestyle habits and will be 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.

On the other hand, the assessment protocol will include their clinical history, different measures of stages of change and nicotine dependence, as well as mental health and quality of life variables. Tobacco consumption will be monitored with biochemical measures (carbon monoxide in exhaled air and cotinine in urine). The efficacy and efficiency of the program will be evaluated at post-treatment and at follow-ups after the end of the intervention (1, 6, and 12 months). This study has been approved by the Ethics Committee of the University of Seville (Ref. 0722-N-22).

The expected results of this research will make it possible to incorporate improvements in routine clinical practice with T2DM smokers, developing a smoking cessation treatment adapted to the specific needs of this population. In addition, this treatment proposal could improve the management of the T2DM disease and comprehensive patient care, as positive impacts are expected that go beyond smoking cessation, such as improved mental health, increased control over possible metabolic changes upon quitting smoking and increased healthy lifestyle habits.

It should be noted that, in the first stage of the DiMe-SALUD2 project, the investigators will conduct a previous pilot study with 15 patients that will be randomly assigned to: 1) Control condition or waiting list; 2) CBT for smoking cessation; 3) CBT for smoking cessation + DiMe-SALUD2 protocol.

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 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.

Primary outcomes:
measure: Smoking abstinence
timeFrame: End of treatment (8-week)
measure: Smoking abstinence
timeFrame: 1-month follow-up
measure: Smoking abstinence
timeFrame: 6-month follow-up
measure: Smoking abstinence
timeFrame: 12-month follow-up
measure: Mean number of days of smoking continuous abstinence
timeFrame: End of treatment (8-week), 1, 6 and 12 months after treatment completion
measure: Variability of glycemic levels
timeFrame: Pre-treatment, in each treatment sessions (sessions at 1-week, 2-week, 3-week, 4-week, 5-week, 6-week, 7-week), end of treatment (8-week), 1-month, 6-months and 12-months after end of treatment
Secondary outcomes:
measure: Treatment retention
timeFrame: End of treatment (8-week), 1, 6 and 12 months after treatment completion
measure: Change in the number of cigarettes smoked per day
timeFrame: End of treatment (8-week), 1, 6 and 12 months after treatment completion
measure: Readiness to change smoking behavior
timeFrame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
measure: Nicotine dependence
timeFrame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
measure: Multidimensional nature of nicotine dependence
timeFrame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
measure: Anxiety
timeFrame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
measure: Depressive symptomatology
timeFrame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
measure: Diabetes quality of life
timeFrame: Pre-treatment, post-treatment, 1, 6 and 12 months after treatment completion
measure: Diet
timeFrame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
measure: Physical activity
timeFrame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
measure: Anthropometric data
timeFrame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
measure: Tobacco Use Disorder Diagnosis
timeFrame: Pre-treatment
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Carla López Núñez
Study officials:
affiliation: Personality, Assessment and Psychological Treatments, School of Psychology, University of Seville
name: Carla López Núñez, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: