Clinical trial NCT05294614: Implementation of a Psychological Online Intervention for Low to Moderate Depression in Primary Health Care
Official title: Implementation of a Psychological Online Intervention for Low to Moderate Depression in Primary Health Care: a Study Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder
Depressive Symptoms
Depression
Keywords: Depressive disorder
Depression
Implementation
Evidence-based intervention
Online intervention
Psychological intervention
Primary care
Health care settings
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital. ACIF/2020/332
First posted: 2022-03-24
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of the intervention
timeFrame: Pre-intervention and immediately after the intervention
Secondary outcomes:
measure: Acceptability
timeFrame: Pre-intervention and immediately after the intervention
measure: Acceptability
timeFrame: Immediately after the intervention
measure: Adaptation
timeFrame: Pre-intervention, immediately after the intervention and follow-up
measure: Adoption, viability and fidelity
timeFrame: Pre-intervention and immediately after the intervention
measure: Implementation costs
timeFrame: Pre-intervention and immediately after the intervention AND follow-up
measure: Diagnostic Interview
timeFrame: Pre-intervention
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Rosa Lorente Català
state: Castellón
Study officials:
affiliation: University Jaume I
name: Azucena García Palacios
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Health Research of Aragon
name: Javier García Campayo
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute of Health Sciences, University of Balearic Islands, Palma de Mallorca
name: Margalida Gili
role: PRINCIPAL_INVESTIGATOR
affiliation: University Regional Hospital of Malaga
name: Fermín Mayoral Cleries
role: PRINCIPAL_INVESTIGATOR
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