Clinical trial NCT03951350: Lifestyle Modification Program in the Prevention and Treatment of Depression
Official title: Effectiveness and Cost-effectiveness of a Lifestyle Modification Program in the Prevention and Treatment of Subclinical, Mild and Moderate Depression in Primary Care: A Randomized Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Lifestyle modifications
Depression
primary health care
Diet
Exercise
Sunlight exposure
Sleep patterns
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction:

Major depression is a highly prevalent pathology that is currently the second most common cause of disease-induced disability in our society. The onset and continuation of depression may be related to a wide variety of biological and psychosocial factors, many of which are linked to different lifestyle aspects. Therefore, health systems must design and implement health promotion and lifestyle modification programs, taking into account personal factors and facilitators. The main objective of this work is to analyze the utility and cost-effectiveness of an adjunctive treatment program for subclinical, mild or moderate depression in Primary Care patients, based on healthier lifestyle recommendations. Secondary objectives include the analysis of the effectiveness of the intervention in comorbid chronic pathology and the measurement of the influence of personal factors on lifestyle modification.

Methods and analysis:

A randomized, multicenter pragmatic clinical trial with 3 parallel groups consisting of primary healthcare patients suffering from subclinical, mild or moderate depression. The following interventions will be used: 1. Usual antidepressant treatment with psychological advice and/or psychotropic drugs prescribed by the General Practitioner (treatment-as-usual, TAU). 2. TAU + Lifestyle Modification Program (LMP). A program to be imparted in 6 weekly 90-minute group sessions, intended to improve the following aspects: behavioral activation + daily physical activity + adherence to the Mediterranean diet pattern + sleep hygiene + careful exposure to sunlight. 3. TAU + LMP + ICTs: healthy lifestyle recommendations (TAU+LMP intervention) + monitoring using ICTs (a wearable smartwatch). The primary outcome will be the depressive symptomatology and the secondary outcomes will be the quality of life, the use of health and social resources, personal variables related to program adherence (patient activation in their own health, self-efficacy, sense of coherence, health literacy and procrastination) and chronic comorbid pathology. Data will be collected before and after the intervention, with 6- and 12-month follow-ups.


Eligibility criteria: Inclusion criteria:

* Individuals over the age of 18.
* Both sexes.
* Having a duration of depression symptoms of at least 2 months.
* Who perfectly understand written and spoken Spanish.
* Who have provided their informed consent.

Exclusion criteria:

* Suffering from another disease that affects the central nervous system (organic brain pathology or having suffered a traumatic brain injury of any severity, dementia).
* Having another psychiatric diagnosis or serious psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders) with the exception of anxious pathology or personality disorders (collected through a medical history and from the Mini-International Neuropsychiatric Interview (MINI) (Ferrando, Bobes, \& Gibert, 2000)).
* Presence of a serious or uncontrolled medical, infectious or degenerative illness that may interfere with the affective symptoms.
* Presence of delirium or hallucinations, risk of suicide, pregnancy or lactation.
* Patients who have participated in another clinical trial over the past 6 months or who are currently in psychotherapy.
* Who practice mindfulness, yoga, meditation or similar practices over the past 6 months, engaging in formal practice at least once a week.
* Presence of any medical, psychological or social problem that could seriously interfere with the patient's participation in the study.

Primary outcomes:
measure: Beck II Self-Applied Depression Inventory (BDI-II)
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
Secondary outcomes:
measure: International Neuropsychiatric Interview (MINI)
timeFrame: Baseline
measure: Comorbidity with chronic diseases
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
measure: European Quality of Life-5 Dimensions questionnaire (EQ-5D)
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
measure: Physical activity questionnaire (IPAQ-SF)
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
measure: Mediterranean Diet Adherence Screener (MEDAS)
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
measure: Patient Activation Questionnaire (PAM) in relation to the management of their health
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
measure: Social support questionnaire (MOS)
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
measure: The Self-Efficacy Scale
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
measure: Sense of coherence questionnaire of Antonovsky
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
measure: Health Literacy Europe questionnaire (HLS-EUQ16)
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
measure: Irrational Procrastination Scale (IPS)
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Alejandra Aguilar-Latorre
Study officials:
References:
citation: Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.
citation: Sanz J, Garcia Vera MP, Espinosa R, Fortun M, Vazquez C. Adaptación española del Inventario para la Depresión de Beck II: Propiedades psicométricas en pacientes con trastornos psicológicos. Clínica y Salud 2005; 16: 121-42.
citation: Badia X, Roset M, Montserrat S, Herdman M, Segura A. [The Spanish version of EuroQol: a description and its applications. European Quality of Life scale]. Med Clin (Barc). 1999;112 Suppl 1:79-85. Spanish.
citation: Drummond MF, Sculpher MJ, Torrance GW, O'Brien B, Stoddart GL: Methods for the Economic Evaluation of Health Care Programmes. Oxford, Oxford University Press; 2005.
citation: Kim Y, Park I, Kang M. Convergent validity of the international physical activity questionnaire (IPAQ): meta-analysis. Public Health Nutr. 2013 Mar;16(3):440-52. doi: 10.1017/S1368980012002996. Epub 2012 Jul 2.
citation: Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ros E, Covas MI, Fiol M, Warnberg J, Aros F, Ruiz-Gutierrez V, Lamuela-Raventos RM, Lapetra J, Munoz MA, Martinez JA, Saez G, Serra-Majem L, Pinto X, Mitjavila MT, Tur JA, Portillo MP, Estruch R; PREDIMED Study Investigators. Cohort profile: design and methods of the PREDIMED study. Int J Epidemiol. 2012 Apr;41(2):377-85. doi: 10.1093/ije/dyq250. Epub 2010 Dec 20. No abstract available.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Sherer M, Maddux JE, Mercandante B, Prentice-Dunn S, Jacobs B, Rogers RW. The Self-Efficacy Scale: Construction and Validation. Psychol Rep 1982;51(2):663 -71.
citation: Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
citation: Antonovsky A. The structure and properties of the sense of coherence scale. Soc Sci Med. 1993 Mar;36(6):725-33. doi: 10.1016/0277-9536(93)90033-z.
citation: Sorensen K, Pelikan JM, Rothlin F, Ganahl K, Slonska Z, Doyle G, Fullam J, Kondilis B, Agrafiotis D, Uiters E, Falcon M, Mensing M, Tchamov K, van den Broucke S, Brand H; HLS-EU Consortium. Health literacy in Europe: comparative results of the European health literacy survey (HLS-EU). Eur J Public Health. 2015 Dec;25(6):1053-8. doi: 10.1093/eurpub/ckv043. Epub 2015 Apr 5.
citation: Guilera G, Barrios M, Penelo E, Morin C, Steel P, Gomez-Benito J. Validation of the Spanish version of the Irrational Procrastination Scale (IPS). PLoS One. 2018 Jan 5;13(1):e0190806. doi: 10.1371/journal.pone.0190806. eCollection 2018.
citation: Ferrando, L., Bobes, J., Gibert, J., Soto, M. y Soto, O. (2000). MINI. Entrevista Neuropsiquiátrica Internacional. Versión en Español 5.0.0. DSM-IV. Traducida por L. Franco-Alfonso, L. Franco. Bajada de http://entomologia.rediris.es /pub/bscw.cgi/ d602335/ MINI/Entrevista Neuropsiquiátrica Internacional.pdf
citation: WHO. (2010). International Classification of Diseases (ICD-10). Family Practice Management.
citation: Katon WJ. Clinical and health services relationships between major depression, depressive symptoms, and general medical illness. Biol Psychiatry. 2003 Aug 1;54(3):216-26. doi: 10.1016/s0006-3223(03)00273-7.
citation: Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
citation: EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
citation: Roman-Viñas, B., Serra-Majem, L., Hagströmer, M., Ribas-Barba, L., Sjöström, M., & Segura-Cardona, R. (2010). International physical activity questionnaire: Reliability and validity in a Spanish population. European Journal of Sport Science, 10(5), 297-304. https://doi.org/10.1080/17461390903426667
citation: Kurtze N, Rangul V, Hustvedt BE. Reliability and validity of the international physical activity questionnaire in the Nord-Trondelag health study (HUNT) population of men. BMC Med Res Methodol. 2008 Oct 9;8:63. doi: 10.1186/1471-2288-8-63.
citation: Schroder H, Fito M, Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Lamuela-Raventos R, Ros E, Salaverria I, Fiol M, Lapetra J, Vinyoles E, Gomez-Gracia E, Lahoz C, Serra-Majem L, Pinto X, Ruiz-Gutierrez V, Covas MI. A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr. 2011 Jun;141(6):1140-5. doi: 10.3945/jn.110.135566. Epub 2011 Apr 20.
citation: Knapp, M. (2001). Economic Evaluation of Mental Health Care. In Contemporary Psychiatry. https://doi.org/10.1007/978-3-642-59519-6_16
citation: de la Revilla-Ahumada L, Luna del Castillo J, Bailón Muñoz E, M. M. I. (2005). [Validation of a questionnaire to measured social support in Primary Care]. Medicina de Familia (Andalucía).
citation: Royuela Rico, A., & Macías Fernández, J. A. (1997). Propiedades clinimétricas de la versión castellana del Cuestionario de Pittsburgh. Vigilia-Sueño.
citation: Moreno Chico, C., González de Paz, L., Monforte Royo, C., Navarro Rubio, M. D., & Gallart Fernández Puebla, A. (2018). Adaptación y validación de la escala de evaluación de la activación "Patient Activation Measure 13" (PAM13) en una muestra de pacientes crónicos visitados en CAP Rambla de MútuaTerrassa. XXIV Premi d'infermeria 2018.
citation: Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
citation: Lopez-Torrecillas F, Garcia J, Canadas GA, Ucles IR, De La Fuente EI. Validity of self-efficacy scale scores for a Spanish sample. Psychol Rep. 2006 Apr;98(2):437-50. doi: 10.2466/pr0.98.2.437-450.
citation: Moreno, B., Alonso, M., & Álvaréz, E. (1997). Sentido de coherencia, personalidad resistente, autoestima y salud. Revista de Psicología de La Salud, 9(2), 115-137.
citation: Nolasco A, Barona C, Tamayo-Fonseca N, Irles MA, Mas R, Tuells J, Pereyra-Zamora P. [Health literacy: psychometric behaviour of the HLS-EU-Q16 questionnaire]. Gac Sanit. 2020 Jul-Aug;34(4):399-402. doi: 10.1016/j.gaceta.2018.08.006. Epub 2018 Nov 22. Spanish.
citation: Steel, P. (2010). Arousal, avoidant and decisional procrastinators: Do they exist? Personality and Individual Differences. https://doi.org/10.1016/j.paid.2010.02.025
citation: Vazquez-Barquero, J. L., Gaite, L., Cuesta, M. J., Garcia, U. E., & Knapp, M. (1997). Spanish version of the CSRI: A mental health cost evaluation interview. [Spanish version of the CSRI: A mental health cost evaluation interview.]. Archivos de Neurobiología.
citation: Aguilar-Latorre A, Navarro C, Olivan-Blazquez B, Gervilla E, Magallon Botaya R, Calafat-Villalonga C, Garcia-Toro M, Boira S, Serrano-Ripoll MJ. Effectiveness and cost-effectiveness of a lifestyle modification programme in the prevention and treatment of subclinical, mild and moderate depression in primary care: a randomised clinical trial protocol. BMJ Open. 2020 Dec 28;10(12):e038457. doi: 10.1136/bmjopen-2020-038457.