Relationship between Overactivity, Stress and anxiety in Anorexia Nervosa
| ISRCTN | ISRCTN45581761 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45581761 |
| Secondary identifying numbers | 8909 |
- Submission date
- 10/11/2010
- Registration date
- 04/08/2011
- Last edited
- 20/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Antonia Koskina
Scientific
Scientific
Psychology PO77
Institute of Psychiatry
London
SE5 8AF
United Kingdom
| Antonia.koskina@kcl.ac.uk |
Study information
| Study design | Multicentre observational non-randomised longitudinal case-controlled study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | ROSANA |
| Study objectives | 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(s) | ref: 09/H0807/4 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 25/02/2010 |
| Completion date | 31/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned sample size: 120 |
| Key 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 |
| Key exclusion criteria | 1. Male 2. Other psychiatric diagnoses 3. Presence of physical illness 4. Learning disability |
| Date of first enrolment | 25/02/2010 |
| Date of final enrolment | 31/08/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Psychology PO77
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
South London and Maudsley NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Michael Rutter Centre for Children
Maudsley Hospital
De Crespigny Park
London
SE5 8AZ
England
United Kingdom
| Website | http://www.slam.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/015803449 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR), ref: RP-PG-0606-1043
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/03/2017: No publications found in PubMed, verifying study status with principal investigator.
