Condition category
Mental and Behavioural Disorders
Date applied
10/11/2010
Date assigned
04/08/2011
Last edited
11/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.slam.nhs.uk/

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

Publication citations

Additional files

Editorial Notes