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

Launched by UNIVERSITY OF SEVILLE · May 22, 2023

Keywords

ClinConnect Summary

The DiMe-SALUD2 Project is a clinical trial designed to help adults with Type 2 Diabetes Mellitus (T2DM) who smoke quit smoking. The study aims to find out how effective a special program is that combines cognitive-behavioral therapy (CBT) for quitting smoking with training on healthy living and managing diabetes. In total, 90 participants will be divided into three groups: one group will only receive basic advice on quitting smoking, the second group will get the CBT program, and the third group will receive both the CBT and the diabetes management training. The researchers want to see which approach works best for helping people quit smoking while managing their diabetes effectively.

To join this study, participants must be at least 18 years old, smoke at least 10 cigarettes a day, and have a diagnosis of Type 2 Diabetes. Those with certain physical or mental health issues that could interfere with the study will not be eligible. Participants can expect to engage in group sessions where they will learn skills to help them quit smoking and improve their health. This study is currently recruiting, and researchers hope that the findings will help improve smoking cessation programs in public health settings, especially for those living with diabetes.

Gender

ALL

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.