Pilot Intervention for Attribution Biases in Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 1
研究概览
简要总结
Both behavioral, psychological, and cognitive differences related to social cognitive function have been related to illness-state in eating disorders, but interventions that directly target these problems are limited. This pilot intervention explores whether a brief art-therapy team-building intervention coupled with psychoeducation about social behavior can change self-concept or clinical symptoms in patients with eating disorders. Participants will complete pre-treatment assessments related to social behaviors and clinical symptoms, attend four two-hour group sessions, and provide two follow-up post-treatment assessments at 1-4 weeks after the treatment and 3-5 months later. Comparisons between the pre-intervention data and the first follow-up will be the primary outcome measures. The primary hypotheses are that participants will show increases in self-esteem and positive self-attributions and decreases in eating disorder symptoms after the intervention. The secondary hypothesis is that other clinical symptoms (depression, anxiety) will be improved after the intervention. Feedback from participants about their experience with the study will assess perceived benefits as well as acquisition of the psychoeducation targets.
详细描述
This project will recruit subjects with eating disorders in the Dallas Fort Worth area. Pre-assessment measures of anxiety, self-esteem, depression, eating disorder symptoms, and attributional style will be completed before the intervention. Participants attend four weekly sessions of a group psychoeducational intervention. The intervention includes an art therapy experiential activity, psychoeducation on social function, reflection and discussion of sample videos and scripts, homework assignments, and guided discussions. Post-assessments will be completed 1-4 weeks and 3-5 months after the interventions is completed.
A. Intake and Screen: Screening checklist for ED symptoms. Demographic Sheet; Clinical History (low BMI); Mini-International Neuropsychiatric Interview for DSM-V (MINI); Eating Disorder Assessment for DSM-V (EDA-5); Wechsler Abbreviated Scale of Intelligence (WASI)
B. Pre/Post Measures (Done at three time points, Pre:1-4 weeks before intervention; Post1: 1-4 weeks after intervention; and Post2: 3-5 months after intervention).
- Internal, Personal, and Situational Attribution Questionnaire, (IPSAQ)
- State Self-Esteem Scale (SSE)
- Trait Self-Esteem Scale (TSE)
- Eating Disorder Examination Questionnaire, (EDE-Q)
- The Quick Inventory of Depression, Clinician-Rated (QIDS)
- Structured Interview Guide for Hamilton Anxiety Scale (SIGH-A)
C. Feedback about the intervention is obtained from queries immediately after the last session and at the follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •eating disorder, current or recent
- •appropriate for partial hospital, intensive outpatient or outpatient treatment
排除标准
- •medically unstable
- •in inpatient or residential treatment
结局指标
主要结局
Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 1
时间窗: Baseline, 4 weeks after intervention
Internal Personal Situational Attributions Questionnaire (IPSAQ) measures externalizing bias (EB) that is calculated by subtracting the number of internal attributions for negative events from the number of internal attributions for positive events. A positive EB score indicates strong self-serving bias (blaming oneself less for negative events than for positive events).
Change in state self-esteem score from Pre-assessment to Post-assessment 1
时间窗: Baseline, 4 weeks after intervention
State Self-Esteem Scale measures a participant's self-esteem at a given point in time. Possible scores range from 0-5 with higher scores indicating better outcome.
Change in trait self-esteem score from Pre-assessment to Post-assessment 1
时间窗: Baseline, 4 weeks after intervention
Rosenberg trait self-esteem scale measures trait self-esteem (TSE). Possible scores range from 0-4 (from 1: strongly disagree, to 4: strongly agree), with higher scores indicating higher TSE.
Study components feedback score
时间窗: 4 weeks after starting intervention
The Attribution Bias Intervention Questionnaire addressed study component feedback using both a rating scales and free form written commentary. Possible scores range from 1 to 10 with higher scores indicating more positive values.
Patient satisfaction score
时间窗: 5-9 weeks after intervention
The Attribution Bias Feedback Form measured patient satisfaction (the impact and value of study) with free-form verbal responses as well as a single rating scale. Possible scores range from 1 to 5 with higher scores indicating more satisfaction with the intervention.
Change in eating disorder symptoms score from Pre- assessment to Post-assessment 1
时间窗: Baseline, 4 weeks after intervention
The Eating Disorder Examination Questionnaire measures the severity of eating disorder symptoms. Possible scores on global eating disorder pathology range from 0 to 6 with higher scores indicating more severity of eating disorder, with scores of 2 or less typical of normative eating behavior/cognitions and scores of 2 to 6 are consistent with eating disorder symptoms, with higher scores suggesting more types of disordered eating are present.
次要结局
- Change in anxiety symptoms score from Pre-assessment to Post-assessment 1(Baseline, 4 weeks after intervention)
- Change in anxiety symptoms score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention)
- Change in eating disorder symptoms score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention)
- Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention)
- Change in state self-esteem score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention)
- Change in trait self-esteem score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention)
- Change in depression symptoms scores from Pre-assessment to Post-assessment 1(Baseline, 4 weeks after intervention)
- Change in depression symptoms scores from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention)
研究者
Carrie McAdams
Associate Professor of Medicine
University of Texas Southwestern Medical Center