Clinical trial NCT06624397: Evaluation of a New Program for Carers of People with Anorexia Nervosa
Official title: Evaluation of a Skills-Based Program for Carers &amp;amp; Families of Patients with Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Carer Stress Syndrome
Keywords: Anorexia Nervosa
Burnout
Carer Burnout
CAREFREE
Lead sponsor: NHS Forth Valley
Sponsor class: OTHER_GOV
Collaborators: name: NHS Lothian
name: University of Stirling
name: NHS Greater Glasgow and Clyde Board HQ
First posted: 2024-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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. CAREFREE is based on a Schema Therapy - 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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

Primary outcomes:
measure: (SRS-Version 3) (Johnson, Miller, &amp; Duncan, 2000).
timeFrame: Weekly after each Carer group Session
measure: Short Rating Scales
timeFrame: Pre (0-6 weeks before group programme begins); Weekly throughout programme; and Post (0-4 weeks after group programme ends)
measure: Experiences in Close Relationships Revised (ECR-R; Fraley et al., 2000; 36 items)
timeFrame: Pre (0-6 weeks before group programme begins) and Post (0-4 weeks after group programme ends) and at 3-months followup
measure: WHOQOL-BREF (WhoQol Group, 1998)
timeFrame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
measure: Depression, anxiety, and stress scale (DASS)
timeFrame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
measure: SCORE-15 Index of Family Functioning and Change (Stratton et al., 2010)
timeFrame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
measure: Family Questionnaire (Wiedemann et al 2002)
timeFrame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
measure: Schema Mode Inventory (Young et al., 2007)
timeFrame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
measure: Eating disorder symptom impact scale (EDSIS; Sepulveda et al., 2008)
timeFrame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
measure: Young Parenting Inventory-revised (YPI-R2; Louis, Wood and Lockwood, 2018)
timeFrame: Pre -group (0-6 weeks before group programme begins)
Secondary outcomes:
measure: Eating Disorder Quality of Life questionnaire (EDQoL; Engel et al., 2006).
timeFrame: Pre (0-6 weeks before group programme begins) and Post (0-4 weeks after group programme ends)
measure: SCORE-15 and Young Parenting Inventory (YPI-R))
timeFrame: Pre (0-6 weeks before group programme begins); and Post (0-4 weeks after group programme ends)
measure: Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ; Rieger et al., 2002)
timeFrame: Pre (0-6 weeks before group programme begins); and Post (0-4 weeks after group programme ends)
measure: Demographics Questionnaire
timeFrame: 0-6 weeks before attending group programme
measure: Qualitative Interview with person with Anorexia Nervosa
timeFrame: 0-4 weeks after group intervention is completed
Other outcomes:
measure: Carer Qualitative interviews and Focus Groups
timeFrame: Focus groups will be carried out immediately following Sessions 6 and 12 - 6 weeks and 12 weeks into the intervention.
measure: Feasibility observations
timeFrame: Feasibility measures will be evaluated immediately following the completion of the Group Programme (i.e. following Session 12 at week 12 of the programme).
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Glasgow
state: Scotland
city: Stirling
country: United Kingdom
facility: NHS Forth Valley
state: Stirlingshire
Study officials:
References: