Evaluation of a New Program for Carers of People with Anorexia Nervosa (CAREFREE)

September 30, 2024 updated by: Dr Susan Simpson, NHS Forth Valley

Evaluation of a Skills-Based Program for Carers & Families of Patients 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G50YZ
    • Stirlingshire
      • Stirling, Stirlingshire, United Kingdom, FK1 5SU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CAREFREE is a 12-session 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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
(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
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)
- 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)
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.
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
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)
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.
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
- 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)
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.
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
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)
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
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
These measure family functioning in the patient with Anorexia Nervosa
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)
This scale measures motivation to recover in the person with Anorexia Nervosa
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
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.
0-6 weeks before attending group programme
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.
0-4 weeks after group intervention is completed

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Focus groups will be carried out immediately following Sessions 6 and 12 - 6 weeks and 12 weeks into the intervention.
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?
Feasibility measures will be evaluated immediately following the completion of the Group Programme (i.e. following Session 12 at week 12 of the programme).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NHS Forth Valley

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NHS Lothian
University of Stirling
NHS Greater Glasgow and Clyde Board HQ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FV1421
  • TCS/22/05 (Other Grant/Funding Number: Chief Scientist Office, Scottish Government)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified patient data will only be shared with researchers who are directly involved in the project in some capacity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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