Evaluation of a Skills-Based Program for Carers & Families of Patients with Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- (SRS-Version 3) (Johnson, Miller, & Duncan, 2000).
研究概览
简要总结
CAREFREE is a 12-session Carer's Programme for carers of adults with moderate to severe Anorexia Nervosa. This programme was developed to provide carers with an opportunity to develop an understanding of Anorexia from a Biopsychosocial framework, taking into account the complex array of biological, psychological and social/environmental factors associated with the development and maintenance of this disorder. The CAREFREE programme is unique in its focus on providing a framework for understanding AN from a Schema -Compassion Focused framework, incorporating psychoeducation in regard to both Anorexia Nervosa and Carer Burnout. The programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion. The CAREFREE programme is open to carers from across Scotland and runs online. Outcomes (including carer and patient quality of life, family communication, patient motivation to change) will be analysed and published at the end of the 24-month period. One of the key benefits of this programme is that as it is a cross-regional-NHS project.
详细描述
Moderate to Severe Anorexia Nervosa (AN-MS)is characterised by poor treatment outcomes, poor quality of life, low motivation levels and ambivalence about change, with high burden on families and NHS services. This study aims to improve quality of life and relationships amongst those with AN-MS and their families/partners/carers, and enhance motivation to recover amongst adults with AN-MS, ultimately resulting in enhanced care and reduced inpatient admissions. We will evaluate a new online group intervention for families/carers and partners. This is a two-phase study: Phase 1 feasibility trial will evaluate factors such as recruitment and retention of clinicians and participants, collection of assessment measures and acceptability of the intervention. Phase 2 will use this information to inform the development of a second more robust feasibility study which will enable us to determine whether this new untested intervention is effective in its own right, as a precursor for a larger definitive trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
(SRS-Version 3) (Johnson, Miller, & Duncan, 2000).
时间窗: Weekly after each Carer group Session
Therapeutic alliance will be evaluated using this 4-item Session Rating Scale after each session
Short Rating Scales
时间窗: Pre (0-6 weeks before group programme begins); Weekly throughout programme; and Post (0-4 weeks after group programme ends)
- VAS scales will used to assess carers' ratings of: (1) Quality of life (taken from the WHOQOL-BREF) and (2) Quality of relationship with the patient with AN. (taken from SCORE-15)
Experiences in Close Relationships Revised (ECR-R; Fraley et al., 2000; 36 items)
时间窗: Pre (0-6 weeks before group programme begins) and Post (0-4 weeks after group programme ends) and at 3-months followup
Assesses self reported individual differences regarding attachment-related anxiety and avoidance.
WHOQOL-BREF (WhoQol Group, 1998)
时间窗: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
This is a World Health Organisation Quality of Life Assessment and is a widely used quality of life instrument which contains 26 items over 4 dimensions - physical health, psychological health, social relationships, environment, quality of life and general health.
Depression, anxiety, and stress scale (DASS)
时间窗: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
Depression, anxiety, and stress scale (DASS) is a 21-item measure assessing depression, anxiety, and stress over the past seven days using a four-point Likert scale. Scores of these three subscales can be added to obtain a total score for psychological distress.
SCORE-15 Index of Family Functioning and Change (Stratton et al., 2010)
时间窗: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
- SCORE is a self report outcome measure designed to be sensitive to the kinds of changes in family relationships that systemic family and couples' therapists see as indications of useful therapeutic change.
Family Questionnaire (Wiedemann et al 2002)
时间窗: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
This questionnaire will be used to measure expressed emotion within the family system.
Schema Mode Inventory (Young et al., 2007)
时间窗: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
5 items of this scale are included in the outcomes to measure healthy functioning.
Eating disorder symptom impact scale (EDSIS; Sepulveda et al., 2008)
时间窗: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
This is a 24-item self-report measure of caregiving burden in eating disorders. The scale comprises of subjective and objective burden across four subscales: managing nutritional situations, dealing with dysregulated behaviors, guilt, and social isolation. Scores are obtained on a five-point Likert scale. Higher scores indicate higher caregiving burden and more negative appraisal of caregiving
Young Parenting Inventory-revised (YPI-R2; Louis, Wood and Lockwood, 2018)
时间窗: Pre -group (0-6 weeks before group programme begins)
This scale assesses perceived parenting experiences. The YPI-R2 is a 36-item questionnaire measuring parenting styles, namely: Competitiveness and Status seeking; Degradation and Rejection; Emotional Inhibition and Deprivation; Overprotection and Overindulgence; Punitiveness; Controlling. Subscale scores are calculated as mean scores with higher scores indicating stronger perceived negative parenting.
次要结局
- Eating Disorder Quality of Life questionnaire (EDQoL; Engel et al., 2006).(Pre (0-6 weeks before group programme begins) and Post (0-4 weeks after group programme ends))
- SCORE-15 and Young Parenting Inventory (YPI-R))(Pre (0-6 weeks before group programme begins); and Post (0-4 weeks after group programme ends))
- Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ; Rieger et al., 2002)(Pre (0-6 weeks before group programme begins); and Post (0-4 weeks after group programme ends))
- Demographics Questionnaire(0-6 weeks before attending group programme)
- Qualitative Interview with person with Anorexia Nervosa(0-4 weeks after group intervention is completed)
研究者
Dr Susan Simpson
Consultant Clinical Psychologist
NHS Forth Valley