An interventional study of CAREFREE Carer's Programme in Anorexia Nervosa and Carer Stress Syndrome, sponsored by NHS Forth Valley. Recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by NHS Forth Valley · Not applicable, Interventional, and Health services research
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Among 21 studies in Anorexia Nervosa with a site in United Kingdom — 4 open to participants now, 7 under way, none of them phase 3. Anorexia Nervosa · United Kingdom.
Among the 21 studies in Anorexia Nervosa with a site in United Kingdom, this one is the 5th largest by planned enrollment of the 16 interventional ones that give a count, is one of 3 that started in 2023, is one of 12 with no phase, and was the 17th registered.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
Browse Anorexia Nervosa studies →4 of the 21 studies in Anorexia Nervosa with a site in United Kingdom are open now. Recruiting first, the newest first:
University of Leicester · Sites in United Kingdom
Ages 16+
Canterbury Christ Church University · Sites in United Kingdom
Ages 18+
University College, London · Sites in United Kingdom
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 83 Anorexia Nervosa studies recruiting now, 18 (22%) set no upper age limit and 61 (73%) stop at 75 or younger; 48 take children under 18; 26 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2
First in 2011; this study’s year is marked. 3 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Median enrollment 32 across the 16 interventional studies, 29 across the 5 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
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1 of 21 have an industry lead sponsor. The 10 most frequent:
NHS Forth Valley is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
NHS Forth Valley has 1 study filed under Anorexia Nervosa — fewer than ten, so there is no comparison to draw.
1 of the studies in Anorexia Nervosa with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06103929University of LeicesterAdult Eating Disorder Assessment Study | 2027-05 |
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Among the 21 studies in Anorexia Nervosa with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Carer Participants
Inclusion Criteria
Exclusion Criteria
Participants with Anorexia
Inclusion Criteria
Exclusion Criteria
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
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.
(SRS-Version 3) (Johnson, Miller, & Duncan, 2000).
Therapeutic alliance will be evaluated using this 4-item Session Rating Scale after each session
Time frame: 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)
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)
Assesses self reported individual differences regarding attachment-related anxiety and avoidance.
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)
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.
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)
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.
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)
- 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.
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)
This questionnaire will be used to measure expressed emotion within the family system.
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)
5 items of this scale are included in the outcomes to measure healthy functioning.
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)
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
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)
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.
Time frame: Pre -group (0-6 weeks before group programme begins)
Eating Disorder Quality of Life questionnaire (EDQoL; Engel et al., 2006).
Measures Quality of Life of the Patient with Anorexia Nervosa
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))
These measure family functioning in the patient with Anorexia Nervosa
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)
This scale measures motivation to recover in the person with Anorexia Nervosa
Time frame: Pre (0-6 weeks before group programme begins); and Post (0-4 weeks after group programme ends)
Demographics Questionnaire
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.
Time frame: 0-6 weeks before attending group programme
Qualitative Interview with person with Anorexia Nervosa
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.
Time frame: 0-4 weeks after group intervention is completed
Carer Qualitative interviews and Focus Groups
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
Time frame: Focus groups will be carried out immediately following Sessions 6 and 12 - 6 weeks and 12 weeks into the intervention.
Feasibility observations
- 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?
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).
Plan to share: Undecided — De-identified patient data will only be shared with researchers who are directly involved in the project in some capacity
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Jun 2025, 25 months after the start.
Of 151 non-industry interventional studies with no phase under Anorexia Nervosa, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's planned 25 months is below that.
Counting every sponsor, half of 151 studies reached it within 43 months; a quarter within 24 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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NHS Forth Valley