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

Universitat Jaume I

Status: Enrolling

Conditions: Depressive Symptoms; Depression; Depressive Disorder

Treatments: Behavioral: "Sonreír es diveritdo" - Smiling is fun

Study type: Interventional

Funder types: Other

Identifiers

NCT05294614

P19/00723

Details and patient eligibility

About

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

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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420 participants in 3 patient groups

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

Other group

Description:

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.

Treatment:

Behavioral: "Sonreír es diveritdo" - Smiling is fun

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

Other group

Description:

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.

Treatment:

Behavioral: "Sonreír es diveritdo" - Smiling is fun

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

Other group

Description:

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.

Treatment:

Behavioral: "Sonreír es diveritdo" - Smiling is fun