Plain English Summary
Background and study aims
Low-intensity psychological approaches using modern means of communication (telephones and computers) could be an effective and cost-effective option for the treatment of depression. This study will compare four different approaches.
Who can participate?
240 depressive patients from primary care centers in Spain.
What does the study involve?
Over a period of seven months, general practitioners from primary health care centers will be invited to refer patients with depressive symptoms. Different investigators will run the psychological assessment and check whether the patients are eligible. Then they will be randomly allocated to one of four groups: treatment as usual (TAU), TAU + mindfulness, TAU + healthy lifestyle, or TAU + positive affect. Patients will be assessed at the start of the study, after the treatment, 6 months and one year later.
What are the possible benefits and risks of participating?
Mindfulness, healthy lifestyle, and positive affect training has been shown to reduce intensity and frequency of symptoms in depressive patients. Due to its low intensity, no side effects are anticipated in any group.
Where is the study run from?
The lead study center is the University of Balearic Islands. The study is being run in association with University Jaume I of Castelló, University of Valencia, University of Zaragoza, and University of Málaga (Spain).
When is the study starting and how long is it expected to run for?
January 2014 to December 2016.
Who is funding the study?
Carlos III Institute of Health (Spain)
Who is the main contact?
Professor Margalida Gili Planas
mgili@uib.es
Trial website
Contact information
Type
Scientific
Primary contact
Prof Margalida Gili Planas
ORCID ID
Contact details
Ctr. Valldemossa km 7,5 - Universidad de las Islas Baleares
Palma de Mallorca
07122
Spain
+34 971173081
mgili@uib.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PI13/01171
Study information
Scientific title
Efficacy of low-intensity psychological intervention applied by (ICTs) for treatment of depression in primary care: a randomised clinical trial
Acronym
Study hypothesis
The project will use four arms to treat depression in primary care centers, treatment as usual (TAU) and three combinations of TAU with another effective techniques dealing with depressive symptoms: mindfulness, healthy lifestyle, and positive affect training. This will allow to detect which approach is the most effective to reduce symptom severity in mild and moderate depressive patient from primary health care centers.
Ethics approval
Research Ethics Committee (IEC) - Department of Health - Government of the Balearic Islands (Comité d'Ètica de la Investigació(CEI) - Consellería de Salut - Govern de les Illes Balears); 29/01/2014; ref. IB 2144/13 PI
Study design
Multicenter controlled randomized clinical trial in four parallel groups
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Depression in primary care patients
Intervention
240 patients will be randomly assigned to one of four treatment arms with sixty patients each one:
1. Treatment As Usual (TAU)
2. TAU + healthy lifestyle
3. TAU + positive affect
4. TAU + mindfulness
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Depressive symptom severity assessed via PHQ-9. It will be registered at three times: baseline, 6 month follow-up, and 12 month follow-up.
Secondary outcome measures
1. Demographic variables
2. Health-related quality of life measured by SF-36
3. Mini-international neuropsychiatric interview
Overall trial start date
01/01/2014
Overall trial end date
01/01/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age over 18
2. DSM 5 diagnose of Major Depression or Dysthymia
3. Mild or moderate depression expressed as score lower than 14 in PHQ-9
4. Depressive symptoms presented for at least last two months
5. Be able to read and understand Spanish language
6. Sign informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant exclusion criteria
1. Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc)
2. Any psychiatric disorder other than Major Depression, Dysthymia, anxiety disorders or personality disorders
3. Any medical, infectious or degenerative disease that may affect mood
4. Presence of delusional ideas or hallucinations consistent or not with mood
5. Suicide risk
Recruitment start date
01/01/2014
Recruitment end date
01/01/2017
Locations
Countries of recruitment
Spain
Trial participating centre
Ctr. Valldemossa km 7,5 - Universidad de las Islas Baleares
Palma de Mallorca
07122
Spain
Sponsor information
Organisation
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Sponsor details
Avda. Monforte de Lemos
5
Madrid
28029
Spain
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
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
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25948287