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

NCT06624397 | Recruiting

• 2 other identifiers: FV1421TCS/22/05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Anorexia Nervosa; Carer Stress Syndrome

Keywords

Anorexia Nervosa; Burnout; Carer Burnout; CAREFREE

Outcome Measures

Primary Outcomes (10)

• (SRS-Version 3) (Johnson, Miller, & Duncan, 2000).

  Therapeutic alliance will be evaluated using this 4-item Session Rating Scale after each session

  Weekly after each Carer group Session

• Short Rating Scales

  \- 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)

  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)

  Assesses self reported individual differences regarding attachment-related anxiety and avoidance.

  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)

  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.

  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)

  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.

  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)

  \- 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.

  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)

  This questionnaire will be used to measure expressed emotion within the family system.

  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)

  5 items of this scale are included in the outcomes to measure healthy functioning.

  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)

  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

  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)

  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.

  Pre -group (0-6 weeks before group programme begins)

Secondary Outcomes (5)

• 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

Other Outcomes (2)

• Carer Qualitative interviews and Focus Groups

  Focus groups will be carried out immediately following Sessions 6 and 12 - 6 weeks and 12 weeks into the intervention.

• Feasibility observations

  Feasibility measures will be evaluated immediately following the completion of the Group Programme (i.e. following Session 12 at week 12 of the programme).

Study Arms (1)

CAREFREE is a 12-session Carer's Programme

EXPERIMENTAL

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 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.

Other: CAREFREE Carer's Programme

Interventions

CAREFREE Carer's Programme OTHER

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 Nervosa and Carer Burnout. The programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion.

CAREFREE is a 12-session Carer's Programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cannot speak/read English
• Is currently suffering from acute psychosis
• Participants with Anorexia
• 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
• Is currently suffering from acute psychotic mental health state

Sponsors & Collaborators

• NHS Forth Valley: lead
• NHS Lothian: collaborator
• University of Stirling: collaborator
• NHS Greater Glasgow and Clyde Board HQ: collaborator

Study Sites (2)

NHS Glasgow

Glasgow, Scotland, G50YZ, United Kingdom

RECRUITING

NHS Forth Valley

Stirling, Stirlingshire, FK1 5SU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa; Burnout, Psychological

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Susan G Simpson, Doctorate Clinical Psychology

CONTACT

44 + 1786458549; susan.g.simpson@nhs.scot

Emma McDonough

CONTACT

44 1324614690; fv.randd-depart@nhs.scot

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Clinical Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 3, 2024
• Study Start: May 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-09

Locations

GB (2)