Condition category
Mental and Behavioural Disorders
Date applied
26/03/2010
Date assigned
18/05/2010
Last edited
14/07/2010
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

Dr Mauro Garcia-Toro

ORCID ID

Contact details

Edificio IUNICS
C/ Ctra de Valldemossa Km 7,5
Palma de Mallorca
07122
Spain
mauro.garcia@uib.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI07/0544

Study information

Scientific title

Effectiveness of hygienic-dietary recommendations as enhancers of antidepressant treatment in patients with Depression

Acronym

HD-Dep

Study hypothesis

Depressed patients who follow hygienic-dietary recommendations will experience an improvement in their clinical course compared with a control group.

Ethics approval

Research and clinical trials ethics committee of the Balearic Islands (CEIC) approved on in February 2008 (ref: 733-06 IB-PI)

Study design

Multicentre two-arm randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression

Intervention

Written recommendations were delivered by the psychiatrist who collaborated in the study.
There were only two recommendations options that were allocated at random.

Intervention group:
1. Go to bed when sleepy and not before 11 o'clock at night. Use the bed and bedroom only for sleep and sex (do not read, watch TV or stay in it during the day). If you do not fall asleep after 15-20 minutes get up and deal in any activity until you have the feeling of sleepiness to go back to bed. Get up early, never later than 9 am, whatever you have slept at night. Do not lie or nap during the day.
2. Walk at least 1 hour a day, at a good pace but without having short of breath or being unable to talk while walking. If you think you have a medical problem which can make your walking troublesome consult your
doctor. Use comfortable footwear for walking and after have a shower or a bath.
3. Be at least 2 hours per day exposed to sunlight, taking precautions to avoid sunburn or sunstroke (sunscreen, hat, etc.)..
4. Try to eat a healthy and balanced diet. Eat at regular hours without turning it between meals, especially sweet or sugary drinks. Eat fish at least three times per week, plus fruit, cereals, nuts and vegetables daily.

Control group:
1. Sleep the hours that your body need to feel you as the good as possible.
2. Adapt the pace of daily physical activity to meet your needs best.
3. If exposed to sunlight take precautions to avoid sunburn or sunstroke (sunscreen, hat, etc.)..
5. Try to eat a healthy and balanced diet.
The total duration of the intervention will be 6 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Score on Hamilton Scale for Depression (HAMD-17) obtained by blinded assessors before and after intervention.

Secondary outcome measures

1. Self-administered Beck Depression Inventory (BDI-21)
2. Clinical Global Impression scale (CGI)
3. SF-36 Health Status (Short-Form SF-36)
All outcomes were measured in the screening visit and final visit after 6 months.

Overall trial start date

11/04/2008

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients of both sexes over 18 years
2. Patients experiencing a depressive episode according to DSM-IV-TR diagnostic criteria (Major depressive disorder, Dysthymic disorder or Bipolar disorder depressive phase)
3. Patient receiving antidepressant treatment
4. Patient who has the ability to communicate and give informed consent in writing
5 . Women of childbearing age using a secure contraception

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 patients

Participant exclusion criteria

1. Patients suffering from another disease that affects CNS (cerebral organic pathology or who has suffered any serious head injury, dementia, etc.)
2. Other psychiatric diagnosis or severe psychiatric illness (substance dependence and abuse, schizophrenia or other psychotic disorders, eating disorders, etc.), except anxious pathology or personality disorders
3. Presence of medical condition severe, uncontrolled, or potentially interfering with affective symptomatology
4. Presence of delusions or hallucinations at the time of the study
5. Significant risk of suicide
6. Pregnancy or lactation

Recruitment start date

11/04/2008

Recruitment end date

31/05/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Edificio IUNICS
Palma de Mallorca
07122
Spain

Sponsor information

Organisation

Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)

Sponsor details

C/ Sinesio Delgado
8.
Madrid
28029
Spain
Oficina.informacion@isciii.es

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) - Health Research Fund (Fondo de Investigaciones Sanitarias [FIS])

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

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20618920

Publication citations

  1. Protocol

    Garcia-Toro M, Ibarra O, Gili M, Salva J, Monzón S, Vives M, Serrano MJ, Garcia-Campayo J, Roca M, Effectiveness of hygienic-dietary recommendations as enhancers of antidepressant treatment in patients with depression: study protocol of a randomized controlled trial., BMC Public Health, 2010, 10, 404, doi: 10.1186/1471-2458-10-404.

Additional files

Editorial Notes