A Multicomponent Smoking Cessation Program for Adults With Type 2 Diabetes Mellitus: A Study Protocol of a Randomized Controlled Trial (DiMe-SALUD2 Project)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Smoking abstinence
研究概览
简要总结
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:
- 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.
- To describe the impact of the CBT for smoking cessation + DiMeSALUD2 protocol on different key variables (explained below).
- 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).
- 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.
详细描述
Despite the fact that there are effective psychological treatments for smoking cessation, studies report that a high percentage of attempts to quit smoking fail and relapse rates after a period of abstinence continue to be high. Thus, it is necessary to incorporate new smoking abstinence and relapse prevention strategies in those treatments implemented with treatment-seeking smokers.
A possible solution to tackle this health problem would be to consider the particular needs of smokers, especially those who have other related pathologies. That is, smoking cessation programs have traditionally been applied to the general population, but there are fewer smoking cessation treatments adapted to the differentiating characteristics of specific groups of the population, especially those who have some type of concurrent physical illness, such as the case of patients with Type 2 Diabetes Mellitus (T2DM). In this sense, smoking behavior is not only related to the etiology of diabetes, but tobacco consumption exerts a harmful effect on these patients, accelerating chronic complications and increasing the risk of mortality.
This study will be conducted through a prospective cohort randomized controlled trial, which will include 90 patients randomly assigned to different conditions:
- Control Group or waiting list (n = 30), which will only receive brief psychoeducation advice about smoking cessation (that is, participants assigned to this control group will participate in the scheduled assessments but without receiving any of the intensive treatments including in the remaining conditions).
- Experimental Group 1 - CBT for smoking cessation (n = 30), where a cognitive-behavioral multicomponent program will be implemented in group-based sessions of four to six patients, once a week over an eight-week period.
- Experimental Group 2 - CBT for smoking cessation + DiMeSALUD2 protocol (n = 30), where the cognitive-behavioral multicomponent program will be applied but adding a specific training protocol on healthy lifestyle habits and self-management of T2DM. The main components of this protocol will be focused on strengthening healthy lifestyle habits and will be 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.
On the other hand, the assessment protocol will include their clinical history, different measures of stages of change and nicotine dependence, as well as mental health and quality of life variables. Tobacco consumption will be monitored with biochemical measures (carbon monoxide in exhaled air and cotinine in urine). The efficacy and efficiency of the program will be evaluated at post-treatment and at follow-ups after the end of the intervention (1, 6, and 12 months). This study has been approved by the Ethics Committee of the University of Seville (Ref. 0722-N-22).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Smoking abstinence
时间窗: 12-month follow-up
Includes 7-day PPA as well as ≤ 4 ppm of carbon monoxide (CO) levels and ≤ 80 ng/ml of cotinine in urine levels.
Variability of glycemic levels
时间窗: 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
Variability of glycemic levels (HbA1c)
Mean number of days of smoking continuous abstinence
时间窗: End of treatment (8-week), 1, 6 and 12 months after treatment completion
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).
次要结局
- Anthropometric data(Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion)
- Treatment retention(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)
- Diet(Pre-treatment, 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)
- Tobacco Use Disorder Diagnosis(Pre-treatment)
- Nicotine dependence(Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion)
- Anxiety(Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion)
- Depressive symptomatology(Pre-treatment, end of treatment (8-week), 1, 6 and 12 months after treatment completion)
- Diabetes quality of life(Pre-treatment, post-treatment, 1, 6 and 12 months after treatment completion)
- Physical activity(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)
研究者
Carla Lopez Nunez
Principal Investigator: Carla López-Núñez, Ph.D. Department of Personality, Assessment and Psychological Treatments, School of Psychology
University of Seville