Efficacy of low-intensity psychological intervention applied by (ICTs) for treatment of depression in primary care

ISRCTN	ISRCTN82388279
DOI	https://doi.org/10.1186/ISRCTN82388279
Secondary identifying numbers	PI13/01171

Submission date: 11/03/2014
Registration date: 16/04/2014
Last edited: 08/06/2020

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

Plain English summary of protocol

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

Contact information

Prof Margalida Gili Planas
Scientific

Ctr. Valldemossa km 7,5 - Universidad de las Islas Baleares
Palma de Mallorca
07122
Spain

Phone	+34 971173081
Email	mgili@uib.es

Study information

Study design	Multicenter controlled randomized clinical trial in four parallel groups
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Efficacy of low-intensity psychological intervention applied by (ICTs) for treatment of depression in primary care: a randomised clinical trial
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2014
Completion date	01/01/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	240
Total final enrolment	221
Key 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
Key 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
Date of first enrolment	01/01/2014
Date of final enrolment	01/01/2017

Locations

Countries of recruitment

Spain

Study participating centre

Ctr. Valldemossa km 7,5 - Universidad de las Islas Baleares

Palma de Mallorca
07122
Spain

Sponsor information

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Hospital/treatment centre

Avda. Monforte de Lemos, 5
Madrid
28029
Spain

Website	http://www.isciii.es/
"ROR"	https://ror.org/00ca2c886

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	07/05/2015		Yes	No
Results article	results	05/06/2020	08/06/2020	Yes	No

Editorial Notes

08/06/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.