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

NCT ID: NCT05294614

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-30
• Study Completion Date: 2023-07-31

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.

Conditions

Depressive Disorder; Depressive Symptoms; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

"Sonreír es diveritdo" - Smiling is fun

Intervention Type: 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 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.

Group Type: OTHER

"Sonreír es diveritdo" - Smiling is fun

Intervention Type: 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

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.

Group Type: OTHER

"Sonreír es diveritdo" - Smiling is fun

Intervention Type: 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.

Interventions

"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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital. ACIF/2020/332

UNKNOWN

Sponsor Role: collaborator

Universitat Jaume I

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Azucena García Palacios

Role: PRINCIPAL_INVESTIGATOR

University Jaume I

Javier García Campayo

Role: PRINCIPAL_INVESTIGATOR

Institute of Health Research of Aragon

Margalida Gili

Role: PRINCIPAL_INVESTIGATOR

Research Institute of Health Sciences, University of Balearic Islands, Palma de Mallorca

Fermín Mayoral Cleries

Role: PRINCIPAL_INVESTIGATOR

University Regional Hospital of Malaga

Locations

Rosa Lorente Català

Castellon, Castellón, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Rosa Lorente Català

Role: CONTACT

rlorente@uji.es

0034691527941

Facility Contacts

Rosa Lorente Català, Psychology

Role: primary

rlorente@uji.es

0034691527941

Azucena García Palacios, Psychology

Role: backup

azucena@uji.es

References

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Other Identifiers

P19/00723

Identifier Type: -

Identifier Source: org_study_id