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Completed

NCT Number: NCT03673982

Carer Skills Training for Inpatients With Anorexia Nervosa (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

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Key information

Age range

17 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tyson West 2, Bethlem Royal Hospital

Beckenham, Kent, BR3 3BX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

iCASK

Behavioral

Materials and support to aid transitions

Primary outcomes

  1. weight change

    Time frame: at time of admission, at time of discharge (average 12-14 weeks)

    weight change over the admission (weight and height will be combined to report BMI in kg/m^2)

Secondary outcomes

  1. Self-Report Questionnaires to assess psychopathological change for patients over admission and post-discharge.

    Time frame: Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months 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

  2. Self-Report Questionnaires for carers, to assess change in perceived burden over admission and post-discharge.

    Time frame: Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months 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

  3. Self-Report Questionnaires for carers, to assess change in perceived confidence over admission and post-discharge.

    Time frame: Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months 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.

  4. Patient satisfaction

    Time frame: at 3 months post-discharge.

    Qualitative feedback from patients, carers and staff - semi-structured interview.

Sponsors and collaborators

Lead sponsor

James Adamson

Other

Registry information

Official study title

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

Acronym: iCASK

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 17, 2018
Registry last updated
Sep 17, 2018

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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