Implementation of a Psychological Online Intervention for Low to Moderate Depression in Primary Health Care

Depression Clinical Trial

Official title:

Implementation of a Psychological Online Intervention for Low to Moderate Depression in Primary Health Care: a Study Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05294614
• Other study ID #: P19/00723
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: July 2023

Study information

• Verified date: June 2022
• Source: Universitat Jaume I
• Contact: Rosa Lorente Català
• Phone: 0034691527941
• Email: rlorente[@]uji.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Implementation of a psychological online intervention for low to moderate depression in primary care settings.

Description:

Depression is highly prevalent in primary care. Meta-analysis show that pharmacotherapy and psychotherapy are effective. Given the high cost of face-to-face psychotherapy, alternative procedures of psychotherapy delivery have been proposed, emphasizing the use of technologies like the Internet. Several studies demostrated the effectiveness of Internet-based psychological interventions in primary care. Once established the efficacy and cost-effectiveness, the next step is the implementation of such programs in routine clinical practise. Literature indicates that there is a gap between the validation of evidence-based interventions and their use in routine practice of around 20 years. The science of implementation has developed procedures to reduce such gap. The objective of this study is to carry out an implementation study with a hybrid design to determine the impact of the intervention (Smiling is Fun) in terms of health outcomes and feasibility of the implementation. Participants will adopt the framework proposed by Hermes et al., inspired in Proctor's recommendations. The study will be conducted in Andalucia, Aragon and Baleares. It is hypothesized that it will be feasible to implement a psychological intervention supported by ICTs in the context of primary care for the treatment of mild-moderate depression. Furthermore, specific hypothesis are established; 1) the intervention will be effective after six months of completion of treatment (efficacy measure: PHQ9), 2) the psychological intervention applied through ICTs in primary care will be cost-effective, 3) the acceptability of the intervention will be high by the agents involved: patients, professionals and administrators (results of interviews and focus groups), this acceptability will also be high with regarding the usability of the designed computer system (measured by the System Usability Scale), 4) the data about the use of the platform by patients and professionals will demonstrate that the intervention is adopted, feasible, and high fidelity (modules and tasks completed) and 5) the adequacy of the ICT-supported intervention perceived by professionals, patients andadministrators will be elevated (NoMAD questionnaire and results of interviews and focus groups).The final goal of this study is to demonstrate the feasibility of using the online intervention in order to guarantee that the investment in efficacy research lead to a better care in routine clinical practice and an improvement in public health.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: July 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: Over 18 years old.
• DSM-5 Diagnosis of Major Depression.
• Severity of mild or moderate depression (score less than 14 points on PHQ-9).
• Duration of depressive symptoms 2 months or more.
• Availability of computer with Internet connection.
• Understand Spanish spoken and written.
• Give informed consent.

Exclusion Criteria:

• Disease affecting the Central Nervous System.
• Other psychiatric diagnosis or illness severe psychiatric (substance dependence and abuse, psychosis, eating disorders, etc.) a exception of anxiety pathology or personality disorders.
• Presence of medical illness, uncontrolled severe degenerative or infectious disease.
• Presence of delusions or hallucinations in the time of study.
• Risk of suicide.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Symptoms

Intervention

Behavioral:
• "Sonreír es diveritdo" - Smiling is fun
Smiling is Fun is an online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules. The modules and their aims are: 1) Motivation for change; advantages and disadvantages of changing and importance of motivation; 2) Understanding emotional problems; psychoeducational information, maintaining factors and management of medication and sleep hygiene; 3) Learning to get going; behavioural activation strategies; 4) Learning to be flexible; how interpret negative thoughts and situations in a more flexible way; 5) Learning to enjoy; importance of positive emotions and strategies to promote them; 6) Learning to live; how to identify the psychological strengths and importance of doing activities based on values and vital goals; 7) Living and learning; putting into practice the strengths identified in previous module; 8) From now on… what?; a relapse prevention module.

Locations

Country	Name	City	State
Spain	Rosa Lorente Català	Castellón De La Plana	Castellón

Sponsors (3)

Lead Sponsor	Collaborator
Universitat Jaume I	Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital. ACIF/2020/332, Ministerio de Ciencia, innovación y universidades. Instituto de Salud Carlos III. REF. P19/00723.

Country where clinical trial is conducted

Spain, 

References & Publications (11)

GBD 2015 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 315 diseases and injuries and healthy life expectancy (HALE), 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1603-1658. doi: 10.1016/S0140-6736(16)31460-X. Erratum in: Lancet. 2017 Jan 7;389(10064):e1. — View Citation

Karyotaki E, Kemmeren L, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schröder J, Bretón-López J, Scheider J, Griffiths K, Farrer L, Huibers MJH, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Is self-guided internet-based cognitive behavioural therapy (iCBT) harmful? An individual participant data meta-analysis. Psychol Med. 2018 Nov;48(15):2456-2466. doi: 10.1017/S0033291718000648. Epub 2018 Mar 15. Review. — View Citation

Karyotaki E, Kleiboer A, Smit F, Turner DT, Pastor AM, Andersson G, Berger T, Botella C, Breton JM, Carlbring P, Christensen H, de Graaf E, Griffiths K, Donker T, Farrer L, Huibers MJ, Lenndin J, Mackinnon A, Meyer B, Moritz S, Riper H, Spek V, Vernmark K, Cuijpers P. Predictors of treatment dropout in self-guided web-based interventions for depression: an 'individual patient data' meta-analysis. Psychol Med. 2015 Oct;45(13):2717-26. doi: 10.1017/S0033291715000665. Epub 2015 Apr 17. Review. — View Citation

Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schröder J, Bretón-López J, Scheider J, Griffiths K, Farrer L, Huibers MJ, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. JAMA Psychiatry. 2017 Apr 1;74(4):351-359. doi: 10.1001/jamapsychiatry.2017.0044. — View Citation

Mira A, Bretón-López J, García-Palacios A, Quero S, Baños RM, Botella C. An Internet-based program for depressive symptoms using human and automated support: a randomized controlled trial. Neuropsychiatr Dis Treat. 2017 Mar 31;13:987-1006. doi: 10.2147/NDT.S130994. eCollection 2017. — View Citation

Mira A, Soler C, Alda M, Baños R, Castilla D, Castro A, García-Campayo J, García-Palacios A, Gili M, Hurtado M, Mayoral F, Montero-Marín J, Botella C. Exploring the Relationship Between the Acceptability of an Internet-Based Intervention for Depression in Primary Care and Clinical Outcomes: Secondary Analysis of a Randomized Controlled Trial. Front Psychiatry. 2019 May 10;10:325. doi: 10.3389/fpsyt.2019.00325. eCollection 2019. — View Citation

Montero-Marín J, Araya R, Pérez-Yus MC, Mayoral F, Gili M, Botella C, Baños R, Castro A, Romero-Sanchiz P, López-Del-Hoyo Y, Nogueira-Arjona R, Vives M, Riera A, García-Campayo J. An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial. J Med Internet Res. 2016 Aug 26;18(8):e231. doi: 10.2196/jmir.5695. — View Citation

Montero-Marín J, Prado-Abril J, Botella C, Mayoral-Cleries F, Baños R, Herrera-Mercadal P, Romero-Sanchiz P, Gili M, Castro A, Nogueira R, García-Campayo J. Expectations among patients and health professionals regarding Web-based interventions for depression in primary care: a qualitative study. J Med Internet Res. 2015 Mar 10;17(3):e67. doi: 10.2196/jmir.3985. — View Citation

Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180. Review. — View Citation

Pakenham-Walsh, Neil. (2004). Learning from one another to bridge the "know-do gap". BMJ. 329. 10.1136/bmj.329.7475.1189.

Romero-Sanchiz P, Nogueira-Arjona R, García-Ruiz A, Luciano JV, García Campayo J, Gili M, Botella C, Baños R, Castro A, López-Del-Hoyo Y, Pérez Ara MÁ, Modrego-Alarcón M, Mayoral Cleríes F. Economic evaluation of a guided and unguided internet-based CBT intervention for major depression: Results from a multi-center, three-armed randomized controlled trial conducted in primary care. PLoS One. 2017 Feb 27;12(2):e0172741. doi: 10.1371/journal.pone.0172741. eCollection 2017. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the intervention	Change of depression symtpmatology through the Patient Health Questionnaire-9 (PHQ-9) after the intervention.	Pre-intervention and immediately after the intervention
Secondary	Acceptability	Assesment of the usability, defined as the facility of use percibed by the users through the System Usability Scale.	Pre-intervention and immediately after the intervention
Secondary	Acceptability	Satisfaction of the online intervention through the Client Satisfaction Questionnaire (CSQ-1).	Immediately after the intervention
Secondary	Adaptation	Assesment of the process of normalization of an intervention through the Normalization MeAsure Development Questionnaire (NoMAD).	Pre-intervention, immediately after the intervention and follow-up
Secondary	Adoption, viability and fidelity	Assessed with the infromation proportioned by the online intervention. Specifically: number of access to the application, number of completed modules and number of performed tasks	Pre-intervention and immediately after the intervention
Secondary	Implementation costs	Assessment of the use of health and social services and other economical impacts thourgh the Client Service Receipt Inventory (CSRI).	Pre-intervention and immediately after the intervention AND follow-up
Secondary	Diagnostic Interview	Assessment of the diagnostic criteria included in the DSM-V.	Pre-intervention