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DepressionNCT03951350

Lifestyle Modification Program in the Prevention and Treatment of Depression

A study testing Lifestyle Modification Program (LMP) and Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs) in people with Depression, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression
What is being tested?
Lifestyle Modification Program (LMP) and Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
1 siteSpain
Study dates
1 Apr 2020to 1 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Alejandra Aguilar-Latorre

    Zaragoza, 50009

Other trials in Spain

About this study

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

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.

Read more

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.

Conditions
Depression
Being tested
Lifestyle Modification Program (LMP), Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs)
Keywords
Lifestyle modifications, Depression, primary health care, Diet, Exercise, Sunlight exposure, Sleep patterns
Medical subject headings
Depression, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle Modification Program (LMP)Behavioural

    Patients will follow TAU and LMP. This program will consist of 6 weekly group sessions (lasting 90 minutes each) led by an experienced psychologist and complemented by PowerPoint presentations. The content is the following:

    1. Presentation of the project and psychoeducation on depression.
    2. Behavior activation.
    3. Sleep hygiene habits and careful exposure to sunlight.
    4. Physical activity.
    5. Adherence to the Mediterranean diet.
    6. Summary of previous sessions with practical final suggestions.
  • Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs)Behavioural

    Patients will follow TAU and LMP and will be monitored using a wearable smart wristwatch that will track their daily sleep patterns and physical activity (LMP+ICTs).

Study groups in NCT03951350
Study groupRoleWhat they receive
Control (TAU)No interventionPatients will follow the usual treatment provided by their GP (treatment-as-usual, TAU).
Lifestyle Modification Program (LMP)ExperimentalIt will consist of 6 weekly group sessions (lasting 90 minutes each).
Receives: Behavioral: Lifestyle Modification Program (LMP); Behavioral: Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs)
Lifestyle Modification Program (LMP) + ICTsExperimentalIt will consist of 6 weekly group sessions (lasting 90 minutes each).
Receives: Behavioral: Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Beck II Self-Applied Depression Inventory (BDI-II)

    The primary outcome will be measured using the BDI-II (Beck et al., 1996). This is a self-report inventory for measuring the severity of depression, consisting of 21 multiple-choice questions with each answer being scored on a scale ranged from 0 to 3. It was translated and validated into Spanish with a reliability of .89 (Sanz et al., 2005). The standardized cutoffs are: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

Secondary outcomes (13)
  1. International Neuropsychiatric Interview (MINI)

    It is a short-term structured diagnostic interview that explores the main psychiatric disorders of Axis I of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and International Classification of Diseases (ICD-10) (Ferrando et al., 2000).

    Measured: Baseline

  2. Comorbidity with chronic diseases

    Comorbidity with chronic diseases will be determined according to the International Classification of Diseases (ICD-10) (WHO, 2010): diabetes (glucose concentration (mg/dl), glycated hemoglobin (%), creatinine), arterial hypertension and diseases of lipid metabolism. In patients with chronic heart disease, coagulation variables will be added. They will be collected from the last blood test or control measurements of the clinical history, taken by their general practitioner (GP) or nurse (assuming they were taken over the past 3 months). Otherwise, their GP will be asked for a blood control test. It is estimated that approximately 50% of these patients will present some comorbidity (Katon, 2003). Anthropometric measures will also be collected (weight, size and perimeter of the waist).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

  3. European Quality of Life-5 Dimensions questionnaire (EQ-5D)

    Health-related quality of life will be measured using the European Quality of Life-5 Dimensions questionnaire (EQ-5D) (Brooks \& De Charro, 1996; The EuroQol Group, 1990). EQ-5D scores will be used to calculate the quality-adjusted life year (QALY) during the monitoring period by adjusting the length of time affected by the health result by the utility value. It contains five health dimensions (mobility, selfcare, usual activities, pain/discomfort and anxiety/depression) and each of these has three levels (no problems, slight problems or moderate and severe problems). The EQ records the patient's self-rated health on a vertical visual analogue scale of 20 centimeters (VAS). The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgment. Patients mark the point on the vertical line that best reflects their assessment of their current global health status (Badia, Roset, Montserrat, Herdman, \& Segura, 1999).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

  4. Physical activity questionnaire (IPAQ-SF)

    Physical activity will be measured using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) (Kim, Park, \& Kang, 2013). It assesses the levels of habitual physical activity over the last 7 days. It has 7 items and records the activity of four intensity levels: vigorous-intensity activity, moderate-intensity activity (walking and sitting). We will use the validated Spanish version (Roman-Viñas et al., 2010). IPAQ-SF has acceptable validity for the measurement of total and vigorous physical activity and poor validity for moderate activity and good reliability (Kurtze, Rangul, \& Hustvedt, 2008).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

  5. Mediterranean Diet Adherence Screener (MEDAS)

    Measured using the 14-item Mediterranean Diet Adherence Screener (MEDAS), developed within the PREDIMED study group (Martínez-González et al., 2010). It includes items on food consumption and intake habits: the use of olive oil as the main source of cooking fat, preference for white meat over red meat, servings of vegetables, portions of fruit, red meat or sausages, servings of animal fat, sugar-sweetened beverages, red wine, legumes, fish, commercial pastries and dressing food with a traditional sauce made of tomatoes, garlic, onion, or leeks sautéed in olive oil. The total score ranges from 0 to 14, with a higher score indicating a better accordance with the Mediterranean diet (Schröder et al., 2011).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

  6. Pittsburgh Sleep Quality Index (PSQI)

    Measured using the Pittsburgh Sleep Quality Index (PSQI) (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989). To measure sleep quality and patterns in adults. It differentiates between "poor" and "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the past month. It consists of 19 self-applied questions and 5 questions that request the evaluation of the patient's bedmate or roommate (these are not scored). Answers range from 0 (no difficulty) to 3 (severe difficulty). The overall score ranges from 0 to 21 points. In its Spanish version, the Cronbach's alpha coefficient is .81, sensitivity of 88.63% and specificity of 74.99%. We will use the validated Spanish version (Royuela Rico \& Macías Fernández, 1997).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

  7. Patient Activation Questionnaire (PAM) in relation to the management of their health

    Measured using the Patient Activation Questionnaire (PAM) with regard to the management of their health. It evaluates the patient's perceived knowledge, skills, and confidence to engage in self-management activities. It has 13 items, a Likert scale from 1 (strongly disagree) to 4 (strongly agree). The resulting score (between 0 and 100) places the individual at one of four levels of activation, each of which reveals insight into a range of health-related characteristics, including behaviors and outcomes. Higher scores indicate higher levels of activation (Hibbard et al., 2004). This scale is only validated in Spanish for chronic patients. It had an item separation index for the parameters of 6.64 and a reliability of .98 (Moreno Chico, González de Paz, Monforte Royo, Navarro Rubio, \& Gallart Fernández Puebla, 2018).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

  8. Social support questionnaire (MOS)

    It will be measured by the Medical Outcomes Study Social Support Survey (MOS-SS) (Sherbourne \& Stewart, 1991). It is a self-report instrument consisting of four subscales (emotional/informational, tangible, affectionate, and positive social interaction) and an overall functional social support index. It has a good reliability (Cronbach's alpha ≥ .91) and is quite stable over time. It has 19 items, a five-point Likert scale. Higher scores indicate more support. We will use the Spanish validated version (de la Revilla-Ahumada L, Luna del Castillo J, \& Bailón Muñoz E, 2005).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

  9. The Self-Efficacy Scale

    Measured using by the Self-Efficacy Scale (Sherer et al., 1982). To measure General Self-Efficacy subscale (17 items including individuals' beliefs in their ability to perform well in a variety of situations) and Social Self-Efficacy subscale (6 items). It contains 23 items that are rated on a 14-point scale (ranging from strongly agree to strongly disagree). Higher scores indicate higher levels of self-efficacy. It has a Cronbach coefficient alpha of .86 for General Self-efficacy subscale and .71 for the Social Self-efficacy subscale. The unpublished Spanish version was translated by Godoy in 1990 (Lopez-Torrecillas, García, Cañadas, Ramirez Ucles, \& de la Fuente, 2006).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

  10. Sense of coherence questionnaire of Antonovsky

    Measured using the Sense of Coherence (SOC) questionnaire by Antonovsky (Antonovsky, 1993). It values the personal disposition towards the assessment of vital experiences. It measures the sense of coherence, comprehensibility, manageability and meaningfulness. It has 13 items scoring between 13 and 91 points. It has consistency rates of between .84 and .93. Higher scores (after reversal of the inverted items) indicate a higher sense of coherence. We will use the validated Spanish version (Moreno, B., Alonso, M., \& Álvaréz, 1997).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

  11. Health Literacy Europe questionnaire (HLS-EUQ16)

    Measured using the Health Literacy Europe Questionnaire (HLS-EUQ16) (Sørensen et al., 2015). It can indicate that the probability of functional literacy in limited health is high, a possibility of functional literacy in limited health, and a functional health literacy in adequate health. It contains 16 items. Higher scores indicate better health literacy. It presents a high consistency (Cronbach's alpha of .982) in the Spanish validation (Nolasco et al., 2018).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

  12. Irrational Procrastination Scale (IPS)

    Measured using the Irrational Procrastination Scale (IPS) (Steel, 2010). To measure general procrastination (dysfunctional delay). It has 9 items, rated on a 5-point Likert scale, with higher scores (after reversal of the three procrastination-inconsistent items) indicating a higher level of procrastination. Its Cronbach's alpha value is 0.90. We will use the validated Spanish version (Guilera et al., 2018).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

  13. Client Service Receipt Inventory (CSRI)

    It will be measured using the Client Service Receipt Inventory (CSRI) (Knapp, 2001). This data may be used for a wide range of applications, including estimates of the costs of service receipt. To collect information on the entire range of services and supports used by study participants. It retrospectively collects data on the use of services over the past 6 months (e.g., rates of use of individual services, mean intensity of service use, rates of accommodation use over time). We will use the validated Spanish version (Vazquez-Barquero, Gaite, Cuesta, Garcia, \& Knapp, 1997).

    Measured: Change from baseline, immediately after the intervention and at six and 12-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2019
  2. Study start1 Apr 2020
  3. Primary completion1 Jul 2020
  4. Study completion1 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03951350
Sponsor's protocol ID
PI18/01336
Status last verified
Feb 2021
First submitted
9 May 2019
Last updated
11 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Proposals should be directed to barbaraolivan@gmail.com. To gain access, data requestors will need to sing a data access agreement. Data will be available for 5 years after we publish the results.

Publications

  • 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.

    PubMed 8991972
  • 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.

  • 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.

    PubMed 10618804
  • 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.

  • 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.

    PubMed 22874087
  • 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.

    PubMed 21172932
  • 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.

    PubMed 2748771
  • 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.

  • 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.

    PubMed 15230939
  • 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.

    PubMed 8480217
  • 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.

    PubMed 25843827
  • 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.

    PubMed 29304119
  • 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

  • WHO. (2010). International Classification of Diseases (ICD-10). Family Practice Management.

  • 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.

    PubMed 12893098

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Modification Program (LMP) and Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs) in people with Depression, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck II Self-Applied Depression Inventory (BDI-II) (time frame: Change from baseline, immediately after the intervention and at six and 12-month follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03951350, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.

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