Carer Skills Training for Inpatients With Anorexia Nervosa (iCASK) (iCASK)

Bridging Transitions From Hospital to Home: Collaborative Skill Sharing Intervention With Carers (iCASK)

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

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: iCASK

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Beckenham, Kent, United Kingdom, BR3 3BX
      • Tyson West 2, Bethlem Royal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iCASK Group; Materials and support to aid transitions.	Behavioral: iCASK; Materials and support to aid transitions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight change	weight change over the admission (weight and height will be combined to report BMI in kg/m^2)	at time of admission, at time of discharge (average 12-14 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months post-discharge.
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	Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months post-discharge.
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.	Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months post-discharge.
Patient satisfaction	Qualitative feedback from patients, carers and staff - semi-structured interview.	at 3 months post-discharge.

Collaborators and Investigators

• Sponsor: James Adamson
• Investigators: Principal Investigator: Janet Treasure, Prof, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Actual): January 25, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: CPMS ID 33235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No