Anorexia NervosaiCASKNCT03673982
Carer Skills Training for Inpatients With Anorexia Nervosa (iCASK)
A study testing iCASK in people with Anorexia Nervosa, run by James Adamson at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 50 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- iCASK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jan 2017to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 17 or over
- DSM-5 diagnosis of Anorexia Nervosa with a body mass index (BMI) of < 18.5 kg/m2
Who cannot join
- Insufficient knowledge of English
- Severe mental or physical illness needing treatment in its own right (e.g. psychosis or diabetes mellitus)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Tyson West 2, Bethlem Royal Hospital
Beckenham, Kent, BR3 3BX
About this study
Official title: 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
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- iCASK
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCASKBehavioural
Materials and support to aid transitions
| Study group | Role | What they receive |
|---|---|---|
| iCASK Group | Experimental | Materials and support to aid transitions. Receives: Behavioral: iCASK |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
weight change over the admission (weight and height will be combined to report BMI in kg/m^2)
Measured: at time of admission, at time of discharge (average 12-14 weeks)
Secondary outcomes (4)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: at 3 months post-discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start9 Jan 2017
- Primary completion25 Jan 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Adamson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, James Adamson, South London and Maudsley NHS Foundation Trust
- Investigators
- Janet Treasure, Prof, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673982
- Sponsor's protocol ID
- CPMS ID 33235
- Acronym
- iCASK
- Status last verified
- Sep 2018
- First submitted
- 16 Mar 2017
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Transitions From Hospital to Home: Collaborative Skill Sharing Intervention With Carers (iCASK)
- ClinicalTrials.gov ID
- NCT03673982
- Acronym / sponsor ID
- iCASK / CPMS ID 33235
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- James AdamsonUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iCASK Group | Experimental | Behavioral: iCASKMaterials and support to aid transitions. |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- aged 17 or over
- DSM-5 diagnosis of Anorexia Nervosa with a body mass index (BMI) of < 18.5 kg/m2
Key exclusion criteria (2 listed)
- Insufficient knowledge of English
- Severe mental or physical illness needing treatment in its own right (e.g. psychosis or diabetes mellitus)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCASKMaterials and support to aid transitions | Behavioural | iCASK Group |
Primary outcome
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)
4 secondary outcomes
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.
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.
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.
Patient satisfaction
Time frame: at 3 months post-discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Treasure, Prof principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCASK in people with Anorexia Nervosa, run by James Adamson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight change (time frame: at time of admission, at time of discharge (average 12-14 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.