Health behaviours, lifestyles, and addictions in a population with affective-emotional problems from primary care

ISRCTN	ISRCTN12820058
DOI	https://doi.org/10.1186/ISRCTN12820058
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Instituto de Investigación Sanitaria Aragón
Funders	Instituto de Investigación Sanitaria Aragón, Instituto de Salud Carlos III

Submission date: 21/03/2022
Registration date: 10/05/2022
Last edited: 18/07/2023

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
From the perspective of the health system, studies confirm that 25-35% of patients who consult primary care suffer from a psychiatric disorder and that more than 80% of them are depression and anxiety disorders. It is interesting to propose various approaches to depression from the primary care setting, among which programs that promote health and change lifestyles are implemented. Today and in more and more studies it is being shown that prevention programs reduce depression in any age range. It has also been observed that healthy lifestyle and exercise programs are effective in preventing affective disorders and addictions. The main aim of this study is to analyze the relationships between personal factors on health behaviour and lifestyle habits.

Who can participate?
People from Aragón (Spain) between the ages of 35 and 74 years

What does the study involve?
Participants answer questions about their lifestyle, perceived quality of life, health behaviours, and addictions. A blood sample will be collected and analysed. The researchers will collect from their medical history if they suffer from any other type of chronic illness, and any drug treatments that they are taking. This first evaluation will last 45 minutes. A total of two visits will be required. Participants will have to travel to a care centre that may not be close to their place of residence, for which there will be no financial compensation.

What are the possible benefits and risks of participating?
As this is a research study aimed at generating knowledge, it is unlikely that participants will obtain any personal benefit from participation, although they will contribute to scientific advancement and social benefit. Participants will not receive any financial compensation. Both for the evaluation and for the blood sample that will be done in this study, participants are not at risk and should not have any discomfort. The questionnaires to be used do not involve any invasive or painful tests and are widely used in research and clinical practice. Both the evaluation and the extraction will be carried out by qualified personnel. The only discomfort participants may have is that of the blood sample, which is a small puncture and slight subsequent bleeding.

Where is the study run from?
Arrabal Health Center in Zaragoza (Spain)

When is the study starting and how long is it expected to run for?
May 2020 to December 2025

Who is funding the study?
1. Instituto de Investigación Sanitaria Aragón (Spain)
2. Carlos III Institute (Spain)

Who is the main contact?
Dr Rosa Magallón Botaya
rosamaga@unizar.es

Contact information

Miss Fátima Méndez-López
Scientific

Aragonese Research Group in Primary Care (GAIAP)
Institute of Health Research
Avenue San Juan Bosco, 13
Zaragoza
50015
Spain

ORCID ID	0000-0002-6409-9041
Phone	+34 (0)976506578
Email	fmendez@iisaragon.es

Dr Rosa Magallón-Botaya
Principal investigator

Aragonese Research Group in Primary Care (GAIAP)
Institute of Health Research
Avenue San Juan Bosco, 13
Zaragoza
50015
Spain

ORCID ID	0000-0002-5494-6550
Phone	+34 (0)976506578
Email	rosamaga@unizar.es

Study information

Primary study design	Observational
Study design	Prospective randomized cohort study
Secondary study design	Cohort study
Participant information sheet	41397_PIS_26Jun20_V3.pdf
Scientific title	Analysis of health behaviours, lifestyles and addictions in a population with affective-emotional problems from primary care: a cohort study
Study objectives	The presence of depressive symptomatology is associated with a low level of health literacy and self-efficacy when seeking, evaluating, understanding and applying health information about self-care.
Ethics approval(s)	Approved 24/06/2020, Comité de Ética de la Investigación de la Comunidad Autónoma de Aragón (CEICA, Avda. San Juan Bosco, 13, 50009, Zaragoza, Spain; +34 (0)976 716584, +34 (0)976 715836; ceica@aragon.es), ref: C.P. - C.I. PI20/302
Health condition(s) or problem(s) studied	Affective-emotional problems
Intervention	From the health center, an information letter will be sent to the participants obtained from said randomization, which includes information on the study procedure and contact details of the research unit so that the participants who are interested in it can contact the equipment for the corresponding initial appointment of the study. The research assistant will call patients who have shown interest in participating in the study and an appointment will be made at their health center. In said appointment, the study will be explained, the inclusion and exclusion criteria will be confirmed, the patient's file will be provided and the informed consent will be signed. If the participants meet the criteria, the research assistant will administer the different questionnaires at the same appointment. At the end of the questionnaire, the researcher prepares a new appointment for blood collection at their assigned health center.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome measures as of 30/08/2022: 1. Severity of depression measured using the Beck Depression Inventory-II (BDI-II) at baseline and 5 years 2. Severity of depression measured using the PHQ-9 at baseline and 5 years 3. Anxiety level measured using the Generalized Anxiety Disorder-7 (GAD-7) at baseline and 5 years _____ Previous primary outcome measure: Severity of depression measured using the Beck Depression Inventory-II (BDI-II) at baseline and 5 years
Key secondary outcome measure(s)	Current primary outcome measures as of 30/08/2022: 1. Sense of coherence measured using the Sense of Coherence Questionnaire (SOC-13) at baseline and 5 years 2. Self-esteem measured using the Rosenberg Questionnaire at baseline and 5 years 3. Comorbidity with chronic diseases determined according to the International Classification of Diseases, Tenth Revision (ICD-10) at baseline and 5 years 4. Clinic variables (TA, Sat O₂ %, BMI, temperature) measured on exploration at baseline and 5 years 5. Analytics (basic biochemistry, hemogram, and coagulation) measured using a complete blood count at baseline and 5 years. 6. Work-family interaction measured using the Work-Family Interaction Questionnaire (SWING) at baseline and 5 years 7. Quality of life in menopausal women measured using the Cervantes Scale at baseline and 5 years 8. The frequency of consumption of substances such as tobacco, alcohol, and narcotic substances measured using an ad hoc questionnaire prepared by the research team at baseline and 5 years 9. Alcohol use disorder measured with the Alcohol Use Disorders Identification Test (AUDIT) questionnaire at baseline and 5 years 10. Pathological gambling measured with the Brief Pathological Gambling Questionnaire (CBJP) at baseline and 5 years 11. Addiction to the use of information and communication technologies measured using the MULTICAGE-TIC Questionnaire at baseline and 5 years 12. Self-efficacy measured with General Self Efficacy Scale-12 (GSES-12) at baseline and 5 years 13. Resilence is measured with Connor–Davidson Resilience Scale (CD-Risc-10) at baseline and 5 years 14. Patient activation measured with Patient Activation Questionnaire (PAM-13) at baseline and 5 years 15. Health literacy measured with Health Literacy Survey European Questionnaire (HLS-EU-Q16) at baseline and 5 years 16. Personality measured with Big Five Inventory-10 (BFI-10) at baseline and 5 years 17. Quality of life measured with European Quality of Life-5 Dimensions Questionnaire (EQ-5D + VAS) at baseline and 5 years 18. Diet measured with Mediterranean Diet Adherence Screener (MEDAS-17) at baseline and 5 years 19. Sleep quality measured with Pittsburgh Sleep Quality Index (PSQI) at baseline and 5 years 20. Physical activity measured with International Physical Activity Questionnaire-Short Form (IPAQ-SF) at baseline and 5 years _____ Previous secondary outcome measures: 1. Sense of coherence measured using the Sense of Coherence Questionnaire (SOC-13) at baseline and 5 years 2. Self-esteem measured using the Rosenberg Questionnaire at baseline and 5 years 3. Comorbidity with chronic diseases determined according to the International Classification of Diseases, Tenth Revision (ICD-10) at baseline and 5 years 4. Clinic variables (TA, Sat O₂ %, BMI, temperature) measured on exploration at baseline and 5 years 5. Analytics (basic biochemistry, hemogram, and coagulation) measured using a complete blood count at baseline and 5 years. 6. Work-family interaction measured using the Work-Family Interaction Questionnaire (SWING) at baseline and 5 years 7. Quality of life in menopausal women measured using the Cervantes Scale at baseline and 5 years 8. The frequency of consumption of substances such as tobacco, alcohol, and narcotic substances measured using an ad hoc questionnaire prepared by the research team at baseline and 5 years 9. Alcohol use disorder measured with the Alcohol Use Disorders Identification Test (AUDIT) questionnaire at baseline and 5 years 10. Pathological gambling measured with the Brief Pathological Gambling Questionnaire (CBJP) at baseline and 5 years 11. Addiction to the use of information and communication technologies measured using the MULTICAGE-TIC Questionnaire at baseline and 5 years
Completion date	01/12/2025

Eligibility

Participant type(s)
Age group	Adult
Sex	All
Target sample size at registration	380
Total final enrolment	400
Key inclusion criteria	1. People aged 35 to 74 years from Aragón (Spain) 2. Understand spoken and written Spanish 3. Informed consent in writing
Key exclusion criteria	1. Suffering from a terminal illness 2. Being institutionalized at the time of the appointment 3. Suffering from an intellectual disability, dementia, or any serious pathology that may seriously interfere with the patient's participation in the study
Date of first enrolment	30/03/2022
Date of final enrolment	30/06/2022

Locations

Countries of recruitment

Spain

Study participating centre

Servicio Aragonés de Salud -Unidad de Investigación Atención Primaria

Aragonese Research Group in Primary Care (GAIAP)
Institute of Health Research
Avenue San Juan Bosco, 13
Zaragoza
50015
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		09/06/2023	27/06/2023	Yes	No
Interim results article	Secondary analysis of baseline data from observational study	04/07/2023	18/07/2023	Yes	No
Participant information sheet	version 3	26/06/2020	28/03/2022	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

41397_PIS_26Jun20_V3.pdf: Participant information sheet

Editorial Notes

18/07/2023: Publication reference added.
27/06/2023: Publication reference added.
09/01/2023: The final enrolment number has been added.
12/12/2022: The intention to publish date was changed from 01/12/2022 to 31/01/2023.
30/08/2022: The following changes have been made:
1. The primary outcome measure has been changed.
2. The secondary outcome measures have been changed.
28/03/2022: Trial's existence confirmed by the Comité de Ética de la Investigación de la Comunidad Autónoma de Aragón (CEICA).