Carer Skills Training for Inpatients With Anorexia Nervosa (iCASK) (iCASK)
Primary Purpose
Anorexia Nervosa
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
iCASK
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
Eligibility Criteria
Inclusion Criteria:
- aged 17 or over
- DSM-5 diagnosis of Anorexia Nervosa with a body mass index (BMI) of < 18.5 kg/m2
Exclusion Criteria:
- Insufficient knowledge of English
- Severe mental or physical illness needing treatment in its own right (e.g. psychosis or diabetes mellitus)
Sites / Locations
- Tyson West 2, Bethlem Royal Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iCASK Group
Arm Description
Materials and support to aid transitions.
Outcomes
Primary Outcome Measures
weight change
weight change over the admission (weight and height will be combined to report BMI in kg/m^2)
Secondary Outcome Measures
Self-Report Questionnaires to assess psychopathological change for patients over admission and post-discharge.
Battery of quantitative self report measures for patients administered at admission, discharge and 3-month follow up.
Primary Questionnaire:
EDEQ (Eating Disorders Questionnaire) - Global score calculated for each time point to assess psychopathological change over time. Reduction in global score would indicate an improvement.
Secondary Measure: A reduction in scores would indicate an improvement, except for AQ-10 which should remain constant if true Autism detected. Scores will be assessed individually using total scores but then combined with EDEQ to look overall at psychopathological change over time.
WSAS (Social Adjustment) - Total Score AQ-10 (Autism Quotient) - Total Score indicates levels of autism symptoms. HADS (Anxiety and Depression Scale) - Total Score MR (Motivational Ruler) - Total Score
Self-Report Questionnaires for carers, to assess change in perceived burden over admission and post-discharge.
Battery of quantitative self report measures for carers administered at admission, discharge and 3-month follow up.
Questionnaire total scores are calculated to provide overview of carer burden. Sub-scales are not used.
Carer Questionnaires: A decrease in overall scores would indicate an improvement.
Burden:
DASS (Depression, Anxiety and Stress Scale) - Total Score used EDSIS (Eating Disorder Symptom Impact Scale) - Total Score used PvAN (Parent vs Anorexia Scale) - Total Score used AESED (accommodation and enabling scale for eating disorders) - Total Score used
Self-Report Questionnaires for carers, to assess change in perceived confidence over admission and post-discharge.
Single quantitative self report questionnaire for carers administered at admission, discharge and 3-month follow up.
Questionnaire total scores are calculated to provide overview of carer confidence. Sub-scales are not used.
Carer Questionnaire:
CASK (Carer Confidence scale) - Total Score used - An increase in score will indicate increased confidence.
Patient satisfaction
Qualitative feedback from patients, carers and staff - semi-structured interview.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03673982
Brief Title
Carer Skills Training for Inpatients With Anorexia Nervosa (iCASK)
Acronym
iCASK
Official Title
Bridging Transitions From Hospital to Home: Collaborative Skill Sharing Intervention With Carers (iCASK)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 9, 2017 (Actual)
Primary Completion Date
January 25, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James Adamson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To improve treatment for patients with severe anorexia nervosa admitted for inpatient care, and to help their families. Inpatients and their families will be offered a novel intervention which includes multimedia training materials. These materials provide guidance in how families can provide support to maintain and build on changes made during inpatient care
Detailed Description
Problem to be solved: Hospital Episode Statistics reveal that admissions for anorexia nervosa are increasing [1]. Admission restores nutrition in a timely manner [2], but psychosocial problems remain and relapse following discharge is common [3]. The mortality post discharge is high [4]. We have found that relapse and bed use post discharge are reduced by a parenting intervention giving the family skills to manage eating disorder behaviours [5].
Innovation: Through a process of co-production, in collaboration with service users and their families, we have developed tools exemplifying emotional coaching behaviour change strategies for patients and their carers (texts, DVDs and podcasts; iCASK programme). These aim of these tools is to improve the transition to outpatient care. These are hosted on a user-friendly, confidential and NHS-compliant platform.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iCASK Group
Arm Type
Experimental
Arm Description
Materials and support to aid transitions.
Intervention Type
Behavioral
Intervention Name(s)
iCASK
Intervention Description
Materials and support to aid transitions
Primary Outcome Measure Information:
Title
weight change
Description
weight change over the admission (weight and height will be combined to report BMI in kg/m^2)
Time Frame
at time of admission, at time of discharge (average 12-14 weeks)
Secondary Outcome Measure Information:
Title
Self-Report Questionnaires to assess psychopathological change for patients over admission and post-discharge.
Description
Battery of quantitative self report measures for patients administered at admission, discharge and 3-month follow up.
Primary Questionnaire:
EDEQ (Eating Disorders Questionnaire) - Global score calculated for each time point to assess psychopathological change over time. Reduction in global score would indicate an improvement.
Secondary Measure: A reduction in scores would indicate an improvement, except for AQ-10 which should remain constant if true Autism detected. Scores will be assessed individually using total scores but then combined with EDEQ to look overall at psychopathological change over time.
WSAS (Social Adjustment) - Total Score AQ-10 (Autism Quotient) - Total Score indicates levels of autism symptoms. HADS (Anxiety and Depression Scale) - Total Score MR (Motivational Ruler) - Total Score
Time Frame
Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months post-discharge.
Title
Self-Report Questionnaires for carers, to assess change in perceived burden over admission and post-discharge.
Description
Battery of quantitative self report measures for carers administered at admission, discharge and 3-month follow up.
Questionnaire total scores are calculated to provide overview of carer burden. Sub-scales are not used.
Carer Questionnaires: A decrease in overall scores would indicate an improvement.
Burden:
DASS (Depression, Anxiety and Stress Scale) - Total Score used EDSIS (Eating Disorder Symptom Impact Scale) - Total Score used PvAN (Parent vs Anorexia Scale) - Total Score used AESED (accommodation and enabling scale for eating disorders) - Total Score used
Time Frame
Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months post-discharge.
Title
Self-Report Questionnaires for carers, to assess change in perceived confidence over admission and post-discharge.
Description
Single quantitative self report questionnaire for carers administered at admission, discharge and 3-month follow up.
Questionnaire total scores are calculated to provide overview of carer confidence. Sub-scales are not used.
Carer Questionnaire:
CASK (Carer Confidence scale) - Total Score used - An increase in score will indicate increased confidence.
Time Frame
Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months post-discharge.
Title
Patient satisfaction
Description
Qualitative feedback from patients, carers and staff - semi-structured interview.
Time Frame
at 3 months post-discharge.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 17 or over
DSM-5 diagnosis of Anorexia Nervosa with a body mass index (BMI) of < 18.5 kg/m2
Exclusion Criteria:
Insufficient knowledge of English
Severe mental or physical illness needing treatment in its own right (e.g. psychosis or diabetes mellitus)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Treasure, Prof
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tyson West 2, Bethlem Royal Hospital
City
Beckenham
State/Province
Kent
ZIP/Postal Code
BR3 3BX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Carer Skills Training for Inpatients With Anorexia Nervosa (iCASK)
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