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

NCT05294614 | Unknown

• 1 other identifier: P19/00723
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depressive Disorder; Depressive Symptoms; Depression

Keywords

Depressive disorder; Depression; Implementation; Evidence-based intervention; Online intervention; Psychological intervention; Primary care; Health care settings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Acceptability

  Pre-intervention and immediately after the intervention

• Acceptability

  Immediately after the intervention

• Adaptation

  Pre-intervention, immediately after the intervention and follow-up

• Adoption, viability and fidelity

  Pre-intervention and immediately after the intervention

• Implementation costs

  Pre-intervention and immediately after the intervention AND follow-up

Study Arms (3)

A B B B B B B B B C C C C C C

OTHER

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

A A B B B B B B B B C C C C C

OTHER

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

A A A B B B B B B B B C C C C

OTHER

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

Interventions

"Sonreír es diveritdo" - Smiling is fun BEHAVIORAL

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.

A A A B B B B B B B B C C C C; A A B B B B B B B B C C C C C; A B B B B B B B B C C C C C C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Jaume I: lead
• Instituto de Salud Carlos III: collaborator
• Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital. ACIF/2020/332: collaborator

Study Sites (1)

Rosa Lorente Català

Castellon, Castellón, 12071, Spain

RECRUITING

Related Publications (12)

• Mira A, Soler C, Alda M, Banos R, Castilla D, Castro A, Garcia-Campayo J, Garcia-Palacios A, Gili M, Hurtado M, Mayoral F, Montero-Marin 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.

  PMID: 31133899 BACKGROUND

• Romero-Sanchiz P, Nogueira-Arjona R, Garcia-Ruiz A, Luciano JV, Garcia Campayo J, Gili M, Botella C, Banos R, Castro A, Lopez-Del-Hoyo Y, Perez Ara MA, Modrego-Alarcon M, Mayoral Cleries 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.

  PMID: 28241025 BACKGROUND

• Montero-Marin J, Araya R, Perez-Yus MC, Mayoral F, Gili M, Botella C, Banos R, Castro A, Romero-Sanchiz P, Lopez-Del-Hoyo Y, Nogueira-Arjona R, Vives M, Riera A, Garcia-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.

  PMID: 27565118 BACKGROUND

• Montero-Marin J, Prado-Abril J, Botella C, Mayoral-Cleries F, Banos R, Herrera-Mercadal P, Romero-Sanchiz P, Gili M, Castro A, Nogueira R, Garcia-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.

  PMID: 25757358 BACKGROUND

• 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, Schroder J, Breton-Lopez 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.

  PMID: 29540243 BACKGROUND

• 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, Schroder J, Breton-Lopez 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.

  PMID: 28241179 BACKGROUND

• Mira A, Breton-Lopez J, Garcia-Palacios A, Quero S, Banos 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.

  PMID: 28408833 BACKGROUND

• 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.

  PMID: 25881626 BACKGROUND

• 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.

  PMID: 27733283 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 22179294 BACKGROUND

• Lorente-Catala R, Gili M, Lopez-Del-Hoyo Y, Mayoral-Cleries F, Perez-Aranda A, Castro A, Varela-Moreno E, Banos RM, Roca M, Monreal-Bartolome A, Garcia-Palacios A. Implementation of a psychological online intervention for low to moderate depression in primary care: study protocol. Internet Interv. 2022 Nov 1;30:100581. doi: 10.1016/j.invent.2022.100581. eCollection 2022 Dec.

  PMID: 36573071 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosa Lorente Català

CONTACT

0034691527941; rlorente@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The present work should be considered as a closed cohort study, since the same participants will be evaluated over time through a series of time points defined a priori and the inclusion of new participants will not be allowed once the trial has started. The design used for this study is composed by 3 sequences (3 different starts of the treatment phase). The assignment of each of the 6 participating centers (2 per each autonomous community) to one of the 3 sequences will be randomly performed. The established sequences look like: A B B B B B B B B C C C C C C A A B B B B B B B B C C C C C A A A B B B B B B B B B C C C C In these sequences A represent the control phase, B the treatment phase and the C the maintenance phase. Participants will be masked to the information related to the sequences that they will follow. The masking will be established according to the randomization applied to each center.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The general framework determined for the study design is that indicated by Hermes. A hybrid type II design, where effectiveness and implementation will be evaluated is selected. Regarding the specific design of the empirical study, a stepped wedge (SW) design will be used, which represent a variation of the clinical trials randomized by clusters. All groups receive the treatment but its initiation is done in a randomized order and the treatment is introduced to different groups in a staggered and sequential way. The duration of each phase (e.g. control and treatment), it is determined randomly for each group. The study should be considered a closed cohort, since the same participants will be evaluated over time through a series of time points defined a priori and the inclusion of new participants will not be allowed once the trial has started. sequences will be randomly assigned.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: March 24, 2022
• Study Start: March 30, 2022
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)