The ACTyourCHANGE Study Protocol. Promoting a Healthy Lifestyle in Patients With Obesity With Acceptance and Commitment Therapy. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Psychological Treatment
研究概览
简要总结
Background: as treatment of choice in promoting psychological flexibility, Acceptance and Commitment Therapy (ACT) was found to be effective in several conditions, and among different populations, including weight management in individuals with obesity. However, the mechanism of action of psychological flexibility is less known. The aim of the present study is, within the context of a brief ACT intervention for behavioral change and behavioral maintenance of a healthy lifestyle in a sample of inpatients with obesity, to explore the effect of each subcomponent of the psychological flexibility model on treatment processes and outcomes.
Methods: a randomized controlled trial will be conducted. 90 Italian adult inpatients with obesity attending a rehabilitation program for weight loss will be randomly allocated into three experimental conditions targeting respectively each subcomponent of the psychological flexibility model: group Engage focused on values-oriented behaviors, group Openness focused on acceptance and cognitive defusion, and group Awareness focused on being present and aware of thought, feelings, and behaviors at every moment. Weight, BMI (Kg/m2), the Psychological General Well Being Inventory (PGWBI), the Outcome Questionnaire-45.2 (OQ-45.2), the Depression Anxiety and Stress Scale (DASS-21), the Difficulties in Emotion regulation scale (DERS) the Dutch eating Behaviors Questionnaire (DEBQ), the Brief Values Inventory (BVI), the Committed Action Questionnaire (CAQ), the Italian-Cognitive Fusion Questionnaire (I-CFQ), and the Five Facet Mindfulness Questionnaire (FFMQ) and the Acceptance and Action Questionnaire (AAQ II) will be assessed at the beginning (Time 0), at the end of psychological intervention (Time 1), after 3 (Time 2) and 6 months (Time 3) and 9 months (Time 4) from discharge. During the following month after discharge, outpatients will be monitored in their adherence to a healthy lifestyle, using a wearable device.
To assess the effectiveness of intervention, mixed between-withing 3 (conditions) x 4 (times) repeated measure ANOVAs will be conducted to examine changes from time 0 to time 1, 2, 3 and 4 in means of weight, BMI, and means scores PGWBI, OQ-45.2, DASS; DERS; DEBQ, AAQ-II, BVI, CAQ, I-CFQ, and FFMQ, between three groups Discussion: This study will contribute to clarify the mechanism of action of each subcomponent of the psychological flexibility model and understand its impact on the promotion of a healthy lifestyle.
详细描述
Obesity is one of the most serious health problems in global public health (Durrer Schutz et al., 2019). Recent estimates pointed out that over the last years obesity reached epidemic proportions, and its prevalence is still rising. In 2016 over 1.9 billion adults in the world were overweight and, of these, more than 650 million were obese (Castelnuovo, Pietrabissa, Manzoni, Cattivelli, Rossi, Novelli, Varallo, 2017).
Defined as an excess of body weight, obesity is a significant risk factor for a plethora of physical, psychological, and social problems, all of which can heavily impact health, quality of life, and global functioning. Obesity is frequently associated with many physical comorbidities, including type II diabetes mellitus, cardiovascular disease, hypertension, kidney failure, and osteoarthritis (Afolabi et al., 2020), psychological problems such as depression, feelings of shame, low self-esteem, stigma (Riva et al., 2006), and eating disorders, as well as social and economic impairment (Kolotkin & Andersen, 2017).
Given the complex nature of the phenomenon, comprehensive multidisciplinary and multi-component lifestyle interventions for the management of obesity in adults are recommended. They include nutrition and dieting, physical activity, and psychological support, aimed at fostering the adoption of a healthy lifestyle through the Cognitive Behavioral Therapy-based interventions considered the gold standard for the treatment of obesity (Giusti et al., 2020).
Even if such programs have been recognized as effective in promoting healthy lifestyle adoption, the maintenance of behavioral change remains challenging. Most obese or overweight people who attend a weight loss rehabilitation program fail to maintain a healthy lifestyle over time. As a consequence, they regain about one-third of the weight lost over the following year after treatment (Castelnuovo & Simpson, 2011; Roberto Cattivelli et al., 2018). This evidence has spurred research to investigate which factors represent barriers to weight loss maintenance and which factors may influence the adoption of healthy lifestyle habits.
Forman and Butryn's conceptual model (Forman & Butryn, 2015) suggest that long-standing adherence to a healthy lifestyle is partially due to some self-regulation skills, such as distress tolerance, values clarity, metacognitive awareness, and behavioral commitment. Such skills were found to play a protective role against the excessive responsiveness to such internal (such as emotions) and external (the availability of tasty food in the modern environment) cues that motivate people to eat palatable food in response to negative internal states, as in case of emotional eating.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written and informed consent to participate; 4) being technology friendly to use wearable devices.
排除标准
- •other psychiatric disturbances (diagnosed according to DSM 5 criteria);
- •other medical conditions not related to obesity that could compromise participation at the study.
研究组 & 干预措施
FACT Module Openness
Participants attending this module are guided to recognize and distancing themselves to stressful thoughts, feelings and sensations. They will learn to read suffering as part of human experience, without self-judgment and self-condemnation. Rather, therapist will encourage the patient's assumption of an open and acceptable approach to internal experiences. Throughout the module, therapist will help patients to reflect on their usual, but ineffective efforts to solve personal problems, and encourage the adoption of new responsive strategies based on acceptance and defusion from personal distress.
An example of metaphor used during the Module is The Passenger on a bus. In this metaphor patient have to imagine to be a driver bus and his every thought is a passenger that gets on and off the bus. This exercise help patients to accept, defuse from, and reduce the power of their thoughts.
干预措施: FACT Module Openness (Behavioral)
FACT Module Engagement
During this module, patients will have the opportunity to increase their motivation to change and encourage the engagement in committed actions, consistent with their life values. Patients are invited to reflect on what is important in their lives, which values make their life worth living, and which actions they could take to live a meaningful life, in accordance with personal values. The use of metaphors and experiential exercises will facilitate the process of exploring personal values, identifying life directions and related behaviors. For example, the 80th Birthday Party metaphor requires participants to imagine there is a party in honor of their birthday and the time comes when people are starting to give speeches and try to answer the question about what they want to hear people at the party say. This exercise help patients in wondering what person they want to be with themselves and others.
干预措施: FACT Module Engagement (Behavioral)
FACT Module Awareness
The module comprises meditation exercises and experiences aimed to learn how to act intentionally with awareness about personal thought and sensations without automatically reacting. Participants are supported to recognize their actions and the context where they occur and learn to choose to respond with action consistent with their values and not automatically. Therapist will propose breathing exercises, body scan and others mindfulness experiences. Participants will be encouraged to sitting comfortably, close the eyes, feel themselves in contact with the present moment they are living, paying attention to their breath, noticing the rhythm and any other aspect of the experience of breathing. Then, the therapist guides the participant's attention on the body, noting any part of their body from the head to feet. Then, the sounds around, any noises that could distract their attention on themselves.
干预措施: FACT Module Awareness (Behavioral)
结局指标
主要结局
Change in Psychological Treatment
时间窗: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)
The third outcome measure is the outcome of psychological treatment. The Outcome Questionnaire-45.2 (Lambert, Gregersen, \& Burlingame, 2004) Italian version by Chiappelli, Coco, Gullo, Bensi, e Prestano (2008) as a measure for the assessment of psychological treatment is a self-report questionnaire composed by 45 items. Subscales are symptoms distress, interpersonal relations and social role functioning. Total Alpha score is excellent (.90 for clinical sample; .92 for non-clinical sample)
Change in Weight
时间窗: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)
The primary outcome of the study is weight loss maintenance. Weight, and height will be assessed to calculate Body Mass Index (BMI= kg/m2). Weight loss maintenance will be assessed considering the difference between initial weight and weight recorded at follow-up. Success in long term weight loss maintenance is achieved if individual loss at list 10% of initial weight, and maintains weight lost for one year (R. R Wing \& Hill, 2001)
Change in Psychological Well-Being
时间窗: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)
The second outcome measure is psychological well-being. The Psychological General Well-Being Inventory (PGWBI; (Dupuy, 1984) Italian validation of Grossi and colleagues (Grossi et al., 2006) consist of 22 self-administered items rated on a 6-point Likert scale, relative to six subscales that offer a measure of the level of subjective psychological well-being. Subscales are anxiety, depression, positive well-being, self-control, general health, and vitality with a range of Alpha's scores from 0.61 to 0.85 for each subscale.
次要结局
- Values(Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3))
- Committed Actions(Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3))
- Psychological inflexibility and experiential avoidance(Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3))
- Acceptance(Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3))
- Awareness(Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3))
- Cognitive Fusion(Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3))