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

June 27, 2022 updated by: Universitat Jaume I

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rosa Lorente Català
  • Phone Number: 0034691527941
  • Email: rlorente@uji.es

Study Locations

  • Spain
    • Castellón
      • Castellón De La Plana, Castellón, Spain, 12071
        • Recruiting
        • Rosa Lorente Català
        • Contact:
          • Rosa Lorente Català, Psychology
          • Phone Number: 0034691527941
          • Email: rlorente@uji.es
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Behavioral: "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.
Other: 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.
Behavioral: "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.
Other: 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.
Behavioral: "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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the intervention
Time Frame: Pre-intervention and immediately after 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: Pre-intervention and immediately after the intervention
Assesment of the usability, defined as the facility of use percibed by the users through the System Usability Scale.
Pre-intervention and immediately after the intervention
Acceptability
Time Frame: Immediately after the intervention
Satisfaction of the online intervention through the Client Satisfaction Questionnaire (CSQ-1).
Immediately after the intervention
Adaptation
Time Frame: 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).
Pre-intervention, immediately after the intervention and follow-up
Adoption, viability and fidelity
Time Frame: 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
Pre-intervention and immediately after the intervention
Implementation costs
Time Frame: 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).
Pre-intervention and immediately after the intervention AND follow-up
Diagnostic Interview
Time Frame: Pre-intervention
Assessment of the diagnostic criteria included in the DSM-V.
Pre-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Jaume I

Collaborators

Instituto de Salud Carlos III
Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital. ACIF/2020/332

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 27, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P19/00723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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