Actively Recruiting
Smoking Cessation Program for Adults With Type 2 Diabetes Mellitus (DiMe-SALUD2 Project)
Led by University of Seville · Updated on 2024-05-08
90
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
U
University of Seville
Lead Sponsor
A
Andalusian Plan for Research, Development, and Innovation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Smoking Cessation Program for Adults With Type 2 Diabetes Mellitus (DiMe-SALUD2 Project)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Being aged 18 or over.
- Having smoked 10 or more cigarettes per day within the last year.
- Meeting nicotine dependence criteria according to DSM-5.
- Baseline carbon monoxide levels equal to or higher than 4 ppm in expired air.
- Cotinine levels in urine more than 80 ng/ml.
- Diagnosis of Type 2 Diabetes Mellitus and receiving routine medical treatment.
- Inclusion of participants with subclinical symptoms of depression and anxiety.
- Inclusion of participants with comorbid physical problems such as cardiorespiratory conditions.
You will not qualify if you...
- Severe psychological or psychiatric disorders such as bipolar disorder, personality disorders, eating disorders, schizophrenia spectrum disorders, or substance use disorders other than nicotine dependence.
- Diagnosis of Type 1 Diabetes Mellitus or gestational diabetes.
- Physical or neurological problems impairing communication.
- Insufficient Spanish language skills to hold a fluid conversation.
- Physical health conditions with treatments incompatible or contraindicated with smoking cessation treatment.
- Receiving other psychological or pharmacological smoking cessation treatments at recruitment.
- Unable to attend all treatment sessions.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Carla López Núñez
Seville, Spain, 41018
Actively Recruiting
Research Team
C
Carla López Núñez, Ph.D.
CONTACT
D
Desirée M. Navas Campaña, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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