Tobacco Use DisorderDiMe-SALUD2NCT05885659
Smoking Cessation Program for Adults With Type 2 Diabetes Mellitus (DiMe-SALUD2 Project)
A study testing Cognitive Behavioral Treatment (CBT) for smoking cessation and CBT for smoking cessation + DiMeSALUD2 protocol in people with Tobacco Use Disorder and Diabetes Mellitus, Type 2, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, Diabetes Mellitus, Type 2
- What is being tested?
- Cognitive Behavioral Treatment (CBT) for smoking cessation and CBT for smoking cessation + DiMeSALUD2 protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Carla López Núñez
Seville, 41018
Carla López Núñez, Ph.D., 0034 954556935, clnunez@us.es
Desirée M. Navas Campaña, Ph.D., 0034 955 64 16 00, dmnavas@uloyola.es
About this study
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)
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:
- 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.
- To describe the impact of the CBT for smoking cessation + DiMeSALUD2 protocol on different key variables (explained below).
- 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).
- 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.
Read the 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:
- 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).
- 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.
- 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.
- Conditions
- Tobacco Use Disorder, Diabetes Mellitus, Type 2
- Being tested
- Control group (waiting list), Cognitive Behavioral Treatment (CBT) for smoking cessation, CBT for smoking cessation + DiMeSALUD2 protocol
- Keywords
- Smoking cessation, Tobacco Use Disorder, Type 2 Diabetes Mellitus, Randomized controlled trial
- Medical subject headings
- Tobacco Use Disorder, Diabetes Mellitus, Type 2, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group (waiting list)Other
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).
Cognitive Behavioral Treatment (CBT) for smoking cessationBehavioural
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.
CBT for smoking cessation + DiMeSALUD2 protocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group (waiting list) | Other | T2DM in the control group will receive brief psychoeducation advice about smoking cessation as well as a general smoking cessation brochure/ booklet. Receives: Other: Control group (waiting list) |
| Experimental 1: Cognitive-behavioral treatment (CBT) for smoking cessation | Active comparator | CBT for smoking cessation, implemented in group-based sessions over an eight-week period. Includes three different stages: (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. Receives: Behavioral: Cognitive Behavioral Treatment (CBT) for smoking cessation |
| Experimental 2: CBT for smoking cessation + DiMeSALUD2 protocol | Active comparator | 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), including healthy lifestyle habits (dietary control and healthy nutrition, physical exercise, and glycemic control). Receives: Behavioral: CBT for smoking cessation + DiMeSALUD2 protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence
Includes 24-hours point prevalence abstinence (PPA) (eight weeks). Abstinence will be measured through carbon monoxide (CO) levels (≤ 4 ppm) and cotinine in urine levels (≤ 80 ng/ml).
Measured: End of treatment (8-week)
Smoking abstinence
Includes 7-day PPA as well as ≤ 4 ppm of carbon monoxide (CO) levels and ≤ 80 ng/ml of cotinine in urine levels.
Measured: 1-month follow-up
Smoking abstinence
Includes 7-day PPA as well as ≤ 4 ppm of carbon monoxide (CO) levels and ≤ 80 ng/ml of cotinine in urine levels.
Measured: 6-month follow-up
Smoking abstinence
Includes 7-day PPA as well as ≤ 4 ppm of carbon monoxide (CO) levels and ≤ 80 ng/ml of cotinine in urine levels.
Measured: 12-month follow-up
Mean number of days of smoking continuous abstinence
Defined as maintained smoking abstinence since the last time participants smoked, even a puff (since quit day). Abstinence will be measured through carbon monoxide (CO) levels (≤ 4 ppm) and cotinine in urine levels (≤ 80 ng/ml).
Measured: End of treatment (8-week), 1, 6 and 12 months after treatment completion
Variability of glycemic levels
Variability of glycemic levels (HbA1c)
Measured: 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 (12)
Treatment retention
Defined as the number of sessions that participants attended during the eight weeks of treatment
Measured: End of treatment (8-week), 1, 6 and 12 months after treatment completion
Change in the number of cigarettes smoked per day
Defined as the reduction in the number of cigarettes smoked per day, since the pre-treatment assessment.
Measured: End of treatment (8-week), 1, 6 and 12 months after treatment completion
Readiness to change smoking behavior
Stages of change regarding tobacco use will be evaluated according to the Prochaska and DiClemente's transtheoretical model of change (Prochaska and DiClemente, 1992; Prochaska et al., 1992).
Measured: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Nicotine dependence
The Fagerström Test for Nicotine Dependence (Heatherton et al., 1991; Spanish adaptation conducted by Becoña \& Vázquez, 1998) will measure changes in nicotine dependence. Total scores range from 0-10, and it includes five levels of dependence (0-2 = very low; 3-4 = low; 5 =moderate; 6-7 = high and 8-10 = very high).
Measured: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Multidimensional nature of nicotine dependence
Brief Wisconsin Inventory of Smoking Dependence Motives (Smith et al., 2010) will measure the multidimensional nature of nicotine dependence, including 11 different subscales classified into Primary Dependence Motives (PDM; Automaticity, Craving, Loss of control, and Tolerance) and Secondary Dependence Motives (SDM; Affiliative Attachment, Behavioral Choice/Melioration, Cognitive Enhancement, Cue Exposure/Associative Processes, Negative Reinforcement, Positive Reinforcement, Social/Environmental Goads, Taste/Sensory Properties, and Weight Control). It includes 37 items with a 7-point Likert scale response format. Higher scores indicate higher nicotine dependence (in each subscale).
Measured: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Anxiety
State-Trait Anxiety Inventory (Spielberg et al., 1983; Spanish version conducted by Buela-Casal et al., 1982) will assess anxiety symptoms across two subscales: State anxiety and Trait anxiety. Scores in each subscale range from 0-60 (higher percentiles indicate higher state or trait anxiety).
Measured: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Depressive symptomatology
Beck's Depression Inventory-Second Edition (Beck et al., 1996; Spanish adaptation of Sanz et al., 2003) will assess the severity of depression. Scores range from 0-63 and it includes different severity levels (0-13 = normal to minimal depression; 20-28 = mild depression; 20-28 = moderate depression; scores above 29 = severe depression).
Measured: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Diabetes quality of life
Diabetes Quality of Life (Jacobson et al., 1988; Spanish version developed by Reviriego et al., 1996), including four subscales: Satisfaction (rated from 1 very satisfied to 5 very dissatisfied); Impact, Worry (social/vocational) and Worry (DM-related), that are rated from from 1 (no impact/never worried) to 5 (always impacted/ worried). Lower scores indicate higher life satisfaction as well as less impact of diabetes on life.
Measured: Pre-treatment, post-treatment, 1, 6 and 12 months after treatment completion
Diet
Mediterranean Diet Adherence Screener (MEDAS) (Schröder et al., 2011) will assess adherence to the Spanish Mediterranean diet thought different items regarding the frequency of both food consumption and food habits. We will use the modified version of 13 items recommended by the Andalusian Government and published by Ángel Maqueda et al. (2020), who delete item 8 related to wine consumption. The MEDAS includes dichotomous response options (0 = non-adherent or 1 = adherent to MD) and results equal to or greater than 8 represent good adherence.
Measured: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Physical activity
International Physical Activity Questionnaire Short Form (Craig et al., 2003) will collect information on the level of physical activity (high, moderate, low/inactive). It evaluates the minutes of walking during the week, as well as the minutes per week of moderate/vigorous physical activity. Each of the activities assessed must be scored on the basis of METS (Metabolic rate units per minute per week). We will use this short version validated in Spanish by Rodríguez-Muñoz et al. (2017) and recommended by the Andalusian Government (Maqueda et al., 2020; Muñoz et al., 2010].
Measured: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Anthropometric data
Body Mass Index
Measured: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Tobacco Use Disorder Diagnosis
The Structured Clinical Interview for the DSM-5 (SCID-5) (First et al., 2016) will be applied. The SCID-5 evaluates the presence of 11 criteria of nicotine dependence in the last year to establish Tobacco Use Disorder severity (absence, minimal, moderate and severe).
Measured: Pre-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Andalusian Plan for Research, Development, and Innovation
- Responsible party
- Principal investigator, Carla Lopez Nunez, University of Seville
- Investigators
- Carla López Núñez, Ph.D, Principal investigator, Personality, Assessment and Psychological Treatments, School of Psychology, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885659
- Sponsor's protocol ID
- ProyExcel_00669
- Acronym
- DiMe-SALUD2
- Status last verified
- May 2024
- First submitted
- 4 May 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Nunez C, Fernandez-Artamendi S, Ruiz-Aranda D, Resurreccion DM, Navas-Campana D. A multicomponent smoking cessation program for adults with Type 2 Diabetes Mellitus (DiMe-SALUD2 project): A study protocol of a randomized controlled trial. Contemp Clin Trials Commun. 2024 Aug 28;41:101361. doi: 10.1016/j.conctc.2024.101361. eCollection 2024 Oct.
PubMed 39290519
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05885659
- Acronym / sponsor ID
- DiMe-SALUD2 / ProyExcel_00669
- Conditions
- Tobacco Use Disorder, Diabetes Mellitus, Type 2
- Keywords
- Smoking cessation, Tobacco Use Disorder, Type 2 Diabetes Mellitus, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Andalusian Plan for Research, Development, and Innovation
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To describe the impact of the CBT for smoking cessation + DiMeSALUD2 protocol on different key variables (explained below).
- 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).
- 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:
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control group (waiting list) | Other | 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. |
| Experimental 1: Cognitive-behavioral treatment (CBT) for smoking cessation | Active comparator | Behavioral: Cognitive Behavioral Treatment (CBT) for smoking cessationCBT for smoking cessation, implemented in group-based sessions over an eight-week period. Includes three different stages: (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. |
| Experimental 2: CBT for smoking cessation + DiMeSALUD2 protocol | Active comparator | Behavioral: CBT for smoking cessation + DiMeSALUD2 protocolIn 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), including healthy lifestyle habits (dietary control and healthy nutrition, physical exercise, and glycemic control). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Control group (waiting list) |
| Cognitive Behavioral Treatment (CBT) for smoking cessationCBT 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. | Behavioural | Experimental 1: Cognitive-behavioral treatment (CBT) for smoking cessation |
| CBT for smoking cessation + DiMeSALUD2 protocolIn 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. | Behavioural | Experimental 2: CBT for smoking cessation + DiMeSALUD2 protocol |
Primary outcome
Smoking abstinence
Time frame: End of treatment (8-week)
Includes 24-hours point prevalence abstinence (PPA) (eight weeks). Abstinence will be measured through carbon monoxide (CO) levels (≤ 4 ppm) and cotinine in urine levels (≤ 80 ng/ml).
Smoking abstinence
Time frame: 1-month follow-up
Includes 7-day PPA as well as ≤ 4 ppm of carbon monoxide (CO) levels and ≤ 80 ng/ml of cotinine in urine levels.
Smoking abstinence
Time frame: 6-month follow-up
Includes 7-day PPA as well as ≤ 4 ppm of carbon monoxide (CO) levels and ≤ 80 ng/ml of cotinine in urine levels.
Smoking abstinence
Time frame: 12-month follow-up
Includes 7-day PPA as well as ≤ 4 ppm of carbon monoxide (CO) levels and ≤ 80 ng/ml of cotinine in urine levels.
Mean number of days of smoking continuous abstinence
Time frame: End of treatment (8-week), 1, 6 and 12 months after treatment completion
Defined as maintained smoking abstinence since the last time participants smoked, even a puff (since quit day). Abstinence will be measured through carbon monoxide (CO) levels (≤ 4 ppm) and cotinine in urine levels (≤ 80 ng/ml).
Variability of glycemic levels
Time frame: 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
Variability of glycemic levels (HbA1c)
12 secondary outcomes
Treatment retention
Time frame: End of treatment (8-week), 1, 6 and 12 months after treatment completion
Change in the number of cigarettes smoked per day
Time frame: End of treatment (8-week), 1, 6 and 12 months after treatment completion
Readiness to change smoking behavior
Time frame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Nicotine dependence
Time frame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Multidimensional nature of nicotine dependence
Time frame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Anxiety
Time frame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Depressive symptomatology
Time frame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Diabetes quality of life
Time frame: Pre-treatment, post-treatment, 1, 6 and 12 months after treatment completion
Diet
Time frame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Physical activity
Time frame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Anthropometric data
Time frame: Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion
Tobacco Use Disorder Diagnosis
Time frame: Pre-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 39290519Lopez-Nunez C, Fernandez-Artamendi S, Ruiz-Aranda D, Resurreccion DM, Navas-Campana D. A multicomponent smoking cessation program for adults with Type 2 Diabetes Mellitus (DiMe-SALUD2 project): A study protocol of a randomized controlled trial. Contemp Clin Trials Commun. 2024 Aug 28;41:101361. doi: 10.1016/j.conctc.2024.101361. eCollection 2024 Oct.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla López Núñez, Ph.D principal investigator
Personality, Assessment and Psychological Treatments, School of Psychology, University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Treatment (CBT) for smoking cessation and CBT for smoking cessation + DiMeSALUD2 protocol in people with Tobacco Use Disorder and Diabetes Mellitus, Type 2, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carla López Núñez, Ph.D. (0034 954556935, clnunez@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking abstinence (time frame: End of treatment (8-week)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05885659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.