A Randomized Controlled Trial Examining Mindfulness Training Effect on Self-monitoring Adherence and Group Cognitive-behavioral Treatment Outcomes Among Women Suffering From Eating Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Treatment outcomes as seen in the compliance to the nutritional instructions (conducted through analyzing the self monitoring documents )
研究概览
简要总结
Bulimia Nervosa (BN), Binge Eating Disorder (BED) and Night Eating Syndrome (NES) are Binge Eating Disorders (BE-Dis) in which binge eating episodes are a main symptom. Cognitive Behavioral Therapy (CBT) is the leading evidence-based treatment for patients suffering from these disorders. CBT-E is an "enhanced" trans-diagnostic version of the treatment which appears to be more effective in a variety of Eating Disorders (EDs). The main goals of this treatment are reducing dietary restrictions and EDs symptoms as well as food intake regulation. Self-monitoring (SM) is an important and central tool in this type of treatment considered crucial for its success. Therefore, during treatment, patients are required to monitor their eating, the circumstances, and their thoughts and feelings proximate to the time of eating. Nevertheless, despite the importance of this tool, research has shown that there are many difficulties challenging the clients' adherence to SM, which might reduce this treatment's effectiveness and outcome. Additionally, in recent years there has been cumulative data supporting the use of mindfulness in the treatment of EDs. Mindfulness, as a western psychological approach, is defined as the "unique non-judgmental focus of one's attention at the present moment". Although SM requires the ability to observe, describe and identify occurrences, no studies have yet examined the direct effect of mindfulness skills on SM adherence, and therefore the improvement of treatment outcomes.
The main objective of the present study is to examine the effect of a mindfulness based intervention on SM adherence during a CBT intervention for BE-Dis, and on the treatment outcomes as seen in the ED psychopathology and compliance to the nutritional instructions and food intake composition. Other aims include examining the differences between the experimental group and the control group, regarding their level of mindfulness and SM adherence. In addition, mediating and moderating processes between mindfulness and SM adherence will be examined.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 18-60 who meet the criteria for BN, BED or NES according to the DSM-V.
- •The participants will be recruited via convenience sampling among patients applying for treatment in the ED unit in "Hanotrim" outpatient clinic ("Shalvata" mental health center) and through internet advertising.
- •Participation in the research program will be allowed only after evaluation and a diagnostic procedure to examine if the criteria for CBT are met in terms of diagnosis and motivational status. This procedure will be conducted through psychological and nutritional intake.
- •Exclusion Criteria (contraindications to starting CBT-E immediately):
- •Current suicidal ideation
- •Current substance/alcohol dependence or abuse
- •Current psychosis
- •Pregnancy (which began prior inclusion)
- •Inability to attend treatment on a regular basis
排除标准
- 未提供
结局指标
主要结局
Treatment outcomes as seen in the compliance to the nutritional instructions (conducted through analyzing the self monitoring documents )
时间窗: Analyzed at 3 time points along the CBT-E program: week 1, week 10, week 19 (end of CBTprogram)
Treatment outcomes regarding the compliance to the nutritional instructions, will be examined by analyzing the participants' self monitoring reports. This analysis will be conducted by comparing the actual number of meals a day and the composition of food consumed (and reported) to dietary recommendations for the treatment of binge eating disorders (Fairburn \& Wilson, 1993). Nutritional composition analysis of food consumed will be conducted by using the "Tzameret" software (of the Israeli Ministry of Health). This procedure will be conducted before (week 1), during (week 10) and at the end of the CBT program (week 19).
Changes in the Clinical Impairment Assesment (CIA) questionnaire
时间窗: 8 Time points: Recruitment (entry to study), pre-CBT-E (5 weeks from recruitment), along CBT-E (10, 5, 20 weeks from recruitment), post-CBT-E (24 weeks from recruitment), follow-up (3 and 6 months post CBT-E = 9 and 12 months post recruitment)
Assessment of psychosocial impairment due to eating disorder will be conducted through CIA (Clinical Impairment Assesment) self-report questionnaire (Bohn \& Fairburn, 2008).
Changes in the Eating Disorder Examination Questionnaire (EDE-Q-I)
时间窗: 8 Time points: Recruitment (entry to study), pre-CBT-E (5 weeks from recruitment), along CBT-E (10, 5, 20 weeks from recruitment), post-CBT-E (24 weeks from recruitment), follow-up (3 and 6 months post CBT-E = 9 and 12 months post recruitment)
EDE-Q-I (Eating Disorder Examination Questionnaire; Fairburn \& Beglin, 1994): A self-report measure of eating disorders psychopathology.
Changes in the Night Eating Questionnaire (NEQ)
时间窗: 8 Time points: Recruitment (entry to study), pre-CBT-E (5 weeks from recruitment), along CBT-E (10, 5, 20 weeks from recruitment), post-CBT-E (24 weeks from recruitment), follow-up (3 and 6 months post CBT-E = 9 and 12 months post recruitment)
Assessment of Night Eating Syndrome psychopathology will be conducted through NEQ (Night Eating Questionnaire) self-report questionnaire (Allison et al., 2008).
Changes in the treatment Outcome Questionnaire-45 (OQ-45)
时间窗: 8 Time points: Recruitment (entry to study), pre-CBT-E (5 weeks from recruitment), along CBT-E (10, 5, 20 weeks from recruitment), post-CBT-E (24 weeks from recruitment), follow-up (3 and 6 months post CBT-E = 9 and 12 months post recruitment)
OQ-45 (Outcome Questionnaire-45) (Lambert et al., 1996) is a self-report scale used to estimate client degree of disturbance at the outset and over the course of treatment. It measures three subscales: symptom distress (depression and anxiety), interpersonal relationships and social role (difficulties in the workplace, school or home duties).
次要结局
- Self monitoring adherence (conducted through scoring the self monitoring content of the participants)(Every week along 19 weeks of CBTE program)