Condition category
Mental and Behavioural Disorders
Date applied
11/03/2014
Date assigned
16/04/2014
Last edited
08/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

http://www.isciii.es/

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

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25948287

Publication citations

Additional files

Editorial Notes