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NCT Number: NCT06624397

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

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.

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Key information

Conditions

Anorexia Nervosa Behavior Behavioral Symptoms Burnout, Psychological Carer Stress Syndrome Feeding and Eating Disorders Mental Disorders Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Glasgow, Glasgow, Scotland, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Weekly after each Carer group Session

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

  2. 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)

    • 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)

  3. 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

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

  4. 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

    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.

  5. 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

    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.

  6. 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

    • 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.

  7. 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

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

  8. 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

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

  9. 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

    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

  10. Young Parenting Inventory-revised (YPI-R2; Louis, Wood and Lockwood, 2018)

    Time frame: 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.

Secondary outcomes

  1. 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)

    Measures Quality of Life of the Patient with Anorexia Nervosa

  2. 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)

    These measure family functioning in the patient with Anorexia Nervosa

  3. 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)

    This scale measures motivation to recover in the person with Anorexia Nervosa

  4. Demographics Questionnaire

    Time frame: 0-6 weeks before attending group programme

    A demographics questionnaire will be filled out by the person with Anorexia Nervosa to ascertain details including: age, age of onset of eating disorder, occupation, relationship with the patient/carer, level of education, postcode, whether or not the person with anorexia is living from home and/or what age they moved out; relationship status, receipt of patient/carer benefits.

  5. Qualitative Interview with person with Anorexia Nervosa

    Time frame: 0-4 weeks after group intervention is completed

    A Qualitative Interview will be carried out with the person with Anorexia Nervosa whose carers are attending the CAREFREE programme, to ascertain their views on the degree to which the programme has impacted family functioning and relationships, as well as their own perspectives in regard to Anorexia Nervosa.

Other outcomes

  1. Carer Qualitative interviews and Focus Groups

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

    Focus groups will focus on quality of life and the achievement of personalised treatment goals (developed with group leaders) will be conducted with carer participants at Mid- and Post- Intervention

  2. Feasibility observations

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

    • What is the feasibility (uptake, retention, dropout, acceptability) of running a novel 12-week group programme for carers, partners and family members of individuals with moderate-severe, treatment resistant and co-morbid AN?(a) Can the investigators recruit clinicians to take part in the study? Can the investigators implement study procedures correctly? Can the investigators implement the intervention with adequate fidelity? (b) Can the investigators recruit patients to the study? How many participants are excluded by the eligibility criteria? How many participants drop out before the end of the study? Can participants complete the assessments? Do participants comply with the intervention? How much missing data is there? (c) What estimates of effect size/variability should be used in the design of the full study?(d) According to carer participant perspectives, what are the most useful aspects of the programme?

Study contacts

Contact information is provided by the study sponsor or research team.

Emma McDonough

CONTACT

[email protected]

44 1324614690

Susan G Simpson, Doctorate Clinical Psychology

CONTACT

[email protected]

44 + 1786458549

Sponsors and collaborators

Lead sponsor

NHS Forth Valley

Other Gov

Collaborators

  • NHS Greater Glasgow and Clyde Board HQ
  • NHS Lothian
  • University of Stirling

Registry information

Official study title

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

Acronym: CAREFREE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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