Smoking cessation program for adults with Type 2 diabetes
A Multicomponent Smoking Cessation Program for Adults With Type 2 Diabetes Mellitus: A Study Protocol of a Randomized Controlled Trial (DiMe-SALUD2 Project)
This study is testing a special program to help adults with Type 2 diabetes quit smoking by comparing different support methods to see which one works best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Seville Academic / other |
| Locations | 1 site (Seville) |
| Trial ID | NCT05885659 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a multicomponent smoking cessation intervention specifically designed for adults with Type 2 Diabetes Mellitus (T2DM). Participants will be randomly assigned to one of three groups: a control group receiving brief psychoeducation, a group receiving cognitive-behavioral treatment (CBT) for smoking cessation, and a group receiving CBT along with a training protocol on healthy lifestyle habits and self-management of T2DM. The study aims to address the unique challenges faced by T2DM smokers and improve their chances of quitting smoking successfully.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 or older who smoke at least 10 cigarettes per day and have a diagnosis of Type 2 Diabetes Mellitus.
Not a fit: Patients with severe psychological or psychiatric disorders, such as bipolar disorder, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve smoking cessation rates among patients with Type 2 Diabetes Mellitus, leading to better health outcomes.
How similar studies have performed: Other studies have shown success with similar cognitive-behavioral approaches for smoking cessation, particularly in populations with comorbid conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seville
- Carla López Núñez — Seville, Spain (Recruiting)
Study contacts
- Principal investigator: Carla López Núñez, Ph.D — Personality, Assessment and Psychological Treatments, School of Psychology, University of Seville
- Study coordinator: Carla López Núñez, Ph.D.
- Email: clnunez@us.es
- Phone: 0034 954556935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.