Implementation of a Psychological Online Intervention for Low to Moderate Depression in Primary Health Care
Study Details
Study Description
Brief Summary
Implementation of a psychological online intervention for low to moderate depression in primary care settings.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: A B B B B B B B B C C C C C C Considering the study design of a closed cohort study, the design of this study is composed by 3 sequences (3 different starts of the treatment phase). In this case, the following arm is established as de first arm of the study: A B B B B B B B B C C C C C C. In this sequence A represent the control phase, B the treatment phase and the C the maintenance phase. |
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.
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Other: A A B B B B B B B B C C C C C Considering the study design of a closed cohort study, the design of this study is composed by 3 sequences (3 different starts of the treatment phase). In this case, the following arm is established as de first arm of the study: A A B B B B B B B B C C C C C. In this sequence A represent the control phase, B the treatment phase and the C the maintenance phase. |
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.
|
Other: A A A B B B B B B B B C C C C Considering the study design of a closed cohort study, the design of this study is composed by 3 sequences (3 different starts of the treatment phase). In this case, the following arm is established as de first arm of the study: A A A B B B B B B B B C C C C. In this sequence A represent the control phase, B the treatment phase and the C the maintenance phase. |
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.
|
Outcome Measures
Primary Outcome Measures
- Efficacy of the intervention [Pre-intervention and immediately after the intervention]
Change of depression symtpmatology through the Patient Health Questionnaire-9 (PHQ-9) after the intervention.
Secondary Outcome Measures
- Acceptability [Pre-intervention and immediately after the intervention]
Assesment of the usability, defined as the facility of use percibed by the users through the System Usability Scale.
- Acceptability [Immediately after the intervention]
Satisfaction of the online intervention through the Client Satisfaction Questionnaire (CSQ-1).
- Adaptation [Pre-intervention, immediately after the intervention and follow-up]
Assesment of the process of normalization of an intervention through the Normalization MeAsure Development Questionnaire (NoMAD).
- Adoption, viability and fidelity [Pre-intervention and immediately after the intervention]
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
- Implementation costs [Pre-intervention and immediately after the intervention AND follow-up]
Assessment of the use of health and social services and other economical impacts thourgh the Client Service Receipt Inventory (CSRI).
- Diagnostic Interview [Pre-intervention]
Assessment of the diagnostic criteria included in the DSM-V.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: Over 18 years old.
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DSM-5 Diagnosis of Major Depression.
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Severity of mild or moderate depression (score less than 14 points on PHQ-9).
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Duration of depressive symptoms 2 months or more.
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Availability of computer with Internet connection.
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Understand Spanish spoken and written.
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Give informed consent.
Exclusion Criteria:
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Disease affecting the Central Nervous System.
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Other psychiatric diagnosis or illness severe psychiatric (substance dependence and abuse, psychosis, eating disorders, etc.) a exception of anxiety pathology or personality disorders.
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Presence of medical illness, uncontrolled severe degenerative or infectious disease.
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Presence of delusions or hallucinations in the time of study.
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Risk of suicide.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Rosa Lorente Català | Castellón De La Plana | Castellón | Spain | 12071 |
Sponsors and Collaborators
- Universitat Jaume I
- Instituto de Salud Carlos III
- Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital. ACIF/2020/332
Investigators
- Principal Investigator: Azucena García Palacios, University Jaume I
- Principal Investigator: Javier García Campayo, Institute of Health Research of Aragon
- Principal Investigator: Margalida Gili, Research Institute of Health Sciences, University of Balearic Islands, Palma de Mallorca
- Principal Investigator: Fermín Mayoral Cleries, University Regional Hospital of Malaga
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- P19/00723