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

NCT05885659 | Recruiting

• 1 other identifier: ProyExcel_00669
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 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. 2.To describe the impact of the CBT for smoking cessation + DiMeSALUD2 protocol on different key variables (explained below).
3. 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. 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

Keywords

Smoking cessation; Tobacco Use Disorder; Type 2 Diabetes Mellitus; Randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• 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).

  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.

  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.

  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.

  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).

  End of treatment (8-week), 1, 6 and 12 months after treatment completion

• Variability of glycemic levels

  Variability of glycemic levels (HbA1c)

  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

  End of treatment (8-week), 1, 6 and 12 months after treatment completion

• Change in the number of cigarettes smoked per day

  End of treatment (8-week), 1, 6 and 12 months after treatment completion

• Readiness to change smoking behavior

  Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion

• Nicotine dependence

  Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion

• Multidimensional nature of nicotine dependence

  Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion

Study Arms (3)

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.

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.

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).

Behavioral: CBT for smoking cessation + DiMeSALUD2 protocol

Interventions

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).

Control group (waiting list)

Cognitive Behavioral Treatment (CBT) for smoking cessation BEHAVIORAL

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.

Experimental 1: Cognitive-behavioral treatment (CBT) for smoking cessation

CBT for smoking cessation + DiMeSALUD2 protocol BEHAVIORAL

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.

Experimental 2: CBT for smoking cessation + DiMeSALUD2 protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead
• Andalusian Plan for Research, Development, and Innovation: collaborator

Study Sites (1)

Carla López Núñez

Seville, 41018, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 39290519 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Diabetes Mellitus, Type 2; Smoking Cessation

Interventions

Control Groups; Waiting Lists

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Carla López Núñez, Ph.D

  Personality, Assessment and Psychological Treatments, School of Psychology, University of Seville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla López Núñez, Ph.D.

CONTACT

0034 954556935; clnunez@us.es

Desirée M. Navas Campaña, Ph.D.

CONTACT

0034 955 64 16 00; dmnavas@uloyola.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The researchers who will develop the pre-treatment evaluation and the intervention program will not participate in the randomization process. The patients will be masked with respect to the study group to which they will belong. On the other hand, psychologists who develop the intervention must necessarily know the type of treatment they are applying (in trials where interventions of a psychological nature are assessed, it is usually not possible to mask the professionals implementing the intervention). However, such psychologists will not participate in the randomization process of the participants or in the analysis of the data, therefore the possible biases of the evaluator regarding such tasks will be deleted. Moreover, the following strategies will be carried out: 1) specialized training on the treatments to be applied, emphasizing the need to maintain masking of the participants; 2) professionals will rotate through all treatment modalities.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Carla López-Núñez, Ph.D. Department of Personality, Assessment and Psychological Treatments, School of Psychology

Model Details: 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).

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 2, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)