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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other 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

Primary outcome measures

• (SRS-Version 3) (Johnson, Miller, & Duncan, 2000). [Time frame: Weekly after each Carer group Session]
• Short Rating Scales [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Pre -group (0-6 weeks before group programme begins)]

Secondary outcome measures (5)

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

Eligibility criteria

Carer Participants

Inclusion criteria

• 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

Exclusion criteria

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

Participants with Anorexia

Inclusion criteria

• 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

Exclusion criteria

• Is currently suffering from acute psychotic mental health state

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

United Kingdom · 2 centers

• NHS Glasgow — Glasgow
• NHS Forth Valley — Stirling

Publications

• 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

Identifiers

NCT: NCT06624397 · FV1421 · TCS/22/05

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗