Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03673982
Other study ID # CPMS ID 33235
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 9, 2017
Est. completion date August 30, 2018

Study information

Verified date September 2018
Source South London and Maudsley NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. These materials provide guidance in how families can provide support to maintain and build on changes made during inpatient care


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date August 30, 2018
Est. primary completion date January 25, 2018
Accepts healthy volunteers No
Gender Female
Age group 17 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
iCASK
Materials and support to aid transitions

Locations

Country Name City State
United Kingdom Tyson West 2, Bethlem Royal Hospital Beckenham Kent

Sponsors (1)

Lead Sponsor Collaborator
James Adamson

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary Patient satisfaction Qualitative feedback from patients, carers and staff - semi-structured interview. at 3 months post-discharge.
See also
  Status Clinical Trial Phase
Recruiting NCT05531604 - Appetitive Conditioning in Anorexia Nervosa
Enrolling by invitation NCT04174703 - Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing N/A
Active, not recruiting NCT04883554 - Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study N/A
Recruiting NCT04213820 - TMS and Body Image Treatment for Anorexia Nervosa N/A
Completed NCT03414112 - The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa Early Phase 1
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Recruiting NCT05803707 - Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study N/A
Recruiting NCT05682417 - Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa N/A
Not yet recruiting NCT06380257 - Anorexia Nervosa and Brain in Adolescence
Not yet recruiting NCT04804800 - Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa N/A
Not yet recruiting NCT03600610 - Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa N/A
Completed NCT02745067 - Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa N/A
Completed NCT02382055 - Changing Habits in Anorexia Nervosa: Novel Treatment Development N/A
Terminated NCT02240797 - Kappa Opioid Receptor Imaging in Anorexia N/A
Completed NCT03075371 - Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa N/A
Completed NCT03144986 - Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa N/A
Unknown status NCT01761942 - Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa Phase 2
Completed NCT01579682 - Adaptive Family Treatment for Adolescent Anorexia Nervosa N/A
Completed NCT02551445 - A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders. N/A
Completed NCT00946816 - The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity N/A