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

Psychology PO77
Institute of Psychiatry
London
SE5 8AF
United Kingdom

Email Antonia.koskina@kcl.ac.uk

Study information

Study designMulticentre observational non-randomised longitudinal case-controlled study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn 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 acronymROSANA
Study objectivesThe 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) studiedAnxiety, Eating disorders
InterventionActiwatch:
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 typeOther
Primary outcome measureBMI, measured weekly and at follow ups (after 6 months)
Secondary outcome measures1. 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 date25/02/2010
Completion date31/08/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsPlanned sample size: 120
Key inclusion criteria1. 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 criteria1. Male
2. Other psychiatric diagnoses
3. Presence of physical illness
4. Learning disability
Date of first enrolment25/02/2010
Date of final enrolment31/08/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Psychology PO77
London
SE5 8AF
United Kingdom

Sponsor information

South London and Maudsley NHS Foundation Trust (UK)
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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

20/03/2017: No publications found in PubMed, verifying study status with principal investigator.