Contact information
Type
Scientific
Primary contact
Miss Antonia Koskina
ORCID ID
Contact details
Psychology PO77
Institute of Psychiatry
London
SE5 8AF
United Kingdom
-
Antonia.koskina@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8909
Study information
Scientific title
An investigation of the relationship between over activity (hyperactivity), anxiety, stress responsiveness and clinical outcomes in patients with anorexia nervosa (AN): a process outcome study in search for a phase advanced clinical marker
Acronym
ROSANA
Study hypothesis
The ROSANA study is a longitudinal observational investigation which runs over the course of 8 weeks, with follow ups at 12 weeks and 24 weeks. We are investigating anxiety, mood, stress responsiveness and physical activity levels as potential key moderators and/or mediators in anorexia nervosa (AN).
Ethics approval
ref: 09/H0807/4
Study design
Multicentre observational non-randomised longitudinal case-controlled study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anxiety, Eating disorders
Intervention
Actiwatch:
A non-invasive well-tolerated device that measures activity levels over a continuous 24-hour period. The device contains an accelerometer to measure the frequency of wrist movements every 1 minute.
Blood sample (AN group only):
An extra vial of blood is collected alongside routine blood for hormonal (leptin, oestrogen, thyrotropin-releasing hormone [TRH], thyroid-stimulating hormone [TSH], R3) and epigenetic (leptin, fat mass and obesity associated gene [FTO], brain-derived neurotrophic factor [BDNF]) analysis.
Body composition and body mass index (BMI):
A 10-minute pain-free procedure in which electrodes are placed on the hands and feet of the patient whilst in a sitting position. A small electrical impulse is sent through the limbs and an analysis of water, fat, muscle and mineral content is made.
Questionnaires:
1. Measured at baseline, week 12 and 24:
1.1. Eating Disorders Examination Questionnaire (EDE-Q)
1.2. Depression Anxiety Stress scale (DASS21)
1.3. Obligatory Exercise Questionnaire (OEQ)
1.4. Reasons for Exercise Inventory (REI)
1.5. Exercise Addiction Inventory (EAI)
1.6. Commitment to Exercise Inventory (CEI)
1.7. Short Evaluation of Eating Disorders (SEED)
2. Weeks 1 - 8:
2.1. International Physical Activity Questionnaire (IPAQ)
2.2. Visual Analogue Scales for Anxiety and Internal Restlessness
2.3. DASS21
Salivary cortisol:
Morning salivary cortisol samples are collected weekly, within 10 minutes of waking. Salivettes are used to collect the sample - it is a non-invasive efficient method of collection. Samples are stored at -20° prior to analysis.
Sleep diary:
A sleep diary is kept over the course of each week, for the first 8 weeks of the study. It details sleep/wake times, quality of sleep and any daytime naps.
Intervention type
Other
Phase
Phase I/II
Drug names
Primary outcome measures
BMI, measured weekly and at follow ups (after 6 months)
Secondary outcome measures
1. Actiwatch data, measured weekly for 8 weeks, at 12 weeks and 24 weeks
2. Body composition, measured at baseline, week 12 and 24
3. Questionnaire data, measured at baseline, week 12 and 24
4. Salivary cortisol, measured weekly for 8 weeks, and at follow ups
Overall trial start date
25/02/2010
Overall trial end date
31/08/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosis of anorexia nervosa (AN) or generalised anxiety disorder (GAD)
2. Females aged 18 years or older, up to 65 years
3. English speaking
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned sample size: 120
Participant exclusion criteria
1. Male
2. Other psychiatric diagnoses
3. Presence of physical illness
4. Learning disability
Recruitment start date
25/02/2010
Recruitment end date
31/08/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychology PO77
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
South London and Maudsley NHS Foundation Trust (UK)
Sponsor details
Michael Rutter Centre for Children
Maudsley Hospital
De Crespigny Park
London
SE5 8AZ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR), ref: RP-PG-0606-1043
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary