Diabetes Mellitus, Type 2 Clinical Trial
— DiMe-SALUD2Official 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: 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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Carla López Núñez | Sevilla |
Lead Sponsor | Collaborator |
---|---|
University of Seville | Andalusian Plan for Research, Development, and Innovation |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Treatment retention | Defined as the number of sessions that participants attended during the eight weeks of treatment | End of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | 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. | End of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | Readiness to change smoking behavior | University of Rhode Island Change Assessment Scale (McConnaughy et al., 1989; McConnaughy et al., 1983; Spanish adaptation Gómez-Peña et al., 2011) will assess readiness to change smoking behavior (precontemplation, contemplation, action, and maintenance). Each subscale is scored from 8-40 points; the highest score indicates the stage in which the person is currently in. | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | 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). | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | 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). | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | Barriers for quitting | Barriers Cessation Scale (Macnee & Talsma, 1995) will focus on assessing general and specific perceived stressors and barriers for quitting, using three subscales (Addiction Barriers, External Barriers and Internal Barriers). Scores range from 0-57, with higher scores indicating a higher perceived barrier. | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | Anxiety sensitivity | Anxiety Sensitivity Index-3 (Taylor et al., 2007; Spanish adaptation of Sandín et al., 2007) will describe the fear of anxiety-related symptomatology, which relates to beliefs and cognitions about possible harmful consequences of aversive internal states through three subscales (physical, cognitive, and social). Scores range from 0-24 in each subscale, with higher scores indicating a more severe anxiety sensitivity level. | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | 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). | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | 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). | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | Distress tolerance | Distress Tolerance Scale (Simons & Gaher, 2005; see Spanish adaptation in Sandín et al., 2017) will measure the smokers' ability to face negative psychological states through four subscales (ability to tolerate emotional distress, subjective appraisal of distress, attention being absorbed by negative emotions and regulation efforts to alleviate distress). Scores range from 15-75 and low scores indicate low distress tolerance. | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | 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. | Pre-treatment, post-treatment, 1, 6 and 12 months after treatment completion | |
Secondary | Diet | Mediterranean Diet Adherence Screener (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. Scores range from 0-14 and a 9, with a score equal to or greater than 9 being considered indicative of good adherence to the Mediterranean diet. | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | Healthy eating habits | Healthy Eating Index (Krebs-Smith et al., 2015) will evaluate the consumption of the main foods (cereals, fruits, vegetables, dairy products and meats) and the compliance with nutritional goals (total fat, saturated fat, cholesterol, sodium, and variety of diet). Each variable is scored between 0-10 8 (maximum value of 100 points). Scores equal to or above 80 are related to healthy eating patterns; between 80-50 indicate the need for dietary modifications; scores below 50 indicate that an unhealthy diet is being followed. | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | Physical activity | International Physical Activity Questionnaire (Roman-Viñas et al., 2010) 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). Less than 600 METS min/week is interpreted as a low level of physical activity, while scores equal to or greater than 600 METS min/week are interpreted as a moderate/high level. | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion | |
Secondary | Anthropometric data | Body Mass Index | Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion |
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