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

Not Applicable

• Conditions: Depressive Disorder; Depressive Symptoms; Depression

• Registration Number: NCT05294614
• Lead Sponsor: Universitat Jaume I

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.

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-03-24
• Study Start: 2022-03-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-07-01
• Primary Completion: 2022-12
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Diagnostic Interview	Pre-intervention	Assessment of the diagnostic criteria included in the DSM-V.
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).
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).

Trial Locations

Locations (1)

Rosa Lorente Català; 🇪🇸 Castellón De La Plana, Castellón, Spain