Evaluation of a New Program for Carers of People with Anorexia Nervosa

Официальное название

Evaluation of a Skills-Based Program for Carers & Families of Patients with Anorexia Nervosa

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое CAREFREE Carer's Programme
  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. 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 Ne

Первичные конечные точки

• (SRS-Version 3) (Johnson, Miller, & Duncan, 2000). [Срок оценки: Weekly after each Carer group Session]
• Short Rating Scales [Срок оценки: Pre (0-6 weeks before group programme begins); Weekly throughout programme; and Post (0-4 weeks after group programme ends)]
• Experiences in Close Relationships Revised (ECR-R; Fraley et al., 2000; 36 items) [Срок оценки: Pre (0-6 weeks before group programme begins) and Post (0-4 weeks after group programme ends) and at 3-months followup]
• WHOQOL-BREF (WhoQol Group, 1998) [Срок оценки: 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) [Срок оценки: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup]
• SCORE-15 Index of Family Functioning and Change (Stratton et al., 2010) [Срок оценки: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup]
• Family Questionnaire (Wiedemann et al 2002) [Срок оценки: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup]
• Schema Mode Inventory (Young et al., 2007) [Срок оценки: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup]
• Eating disorder symptom impact scale (EDSIS; Sepulveda et al., 2008) [Срок оценки: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup]
• Young Parenting Inventory-revised (YPI-R2; Louis, Wood and Lockwood, 2018) [Срок оценки: Pre -group (0-6 weeks before group programme begins)]

Вторичные конечные точки (5)

• Eating Disorder Quality of Life questionnaire (EDQoL; Engel et al., 2006). [Срок оценки: 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)) [Срок оценки: 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) [Срок оценки: Pre (0-6 weeks before group programme begins); and Post (0-4 weeks after group programme ends)]
• Demographics Questionnaire [Срок оценки: 0-6 weeks before attending group programme]
• Qualitative Interview with person with Anorexia Nervosa [Срок оценки: 0-4 weeks after group intervention is completed]

Критерии участия

Carer Participants

Критерии включения

• Has a family member, partner or spouse/partner with moderate-severe, treatment resistant and/or co-morbid anorexia nervosa (as diagnosed by a clinician at one these centres)
• Is over the age of 17
• Can speak and read English
• Has access to the internet and is comfortable using an online meeting platform

Критерии исключения

• Cannot speak/read English
• Is currently suffering from acute psychosis

Participants with Anorexia

Критерии включения

• Have moderate-severe, treatment resistant and/or co-morbid anorexia nervosa (as diagnosed by a clinician at one these centres)
• Is over 17 years of age
• Can speak and read English

Критерии исключения

• Is currently suffering from acute psychotic mental health state

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Великобритания · 2 центра

• NHS Glasgow — Glasgow
• NHS Forth Valley — Stirling

Публикации

• Mawdsley E, McNicol S, Rutherford AC, Symon L, Smith D, Elliott H, Simpson S. A case series evaluation of a schema therapy-coaching programme for carers of patients with moderate to severe anorexia nervosa: the CAREFREE programme. J Eat Disord. 2026 Jul 16. doi: 10.1186/s40337-026-01704-9. Online ahead of print. PMID 42458655

Идентификаторы

NCT: NCT06624397 · FV1421 · TCS/22/05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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