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

Primary Purpose

Depressive Disorder, Depressive Symptoms, Depression

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
"Sonreír es diveritdo" - Smiling is fun
Sponsored by
Universitat Jaume I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Depressive disorder, Depression, Implementation, Evidence-based intervention, Online intervention, Psychological intervention, Primary care, Health care settings

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Rosa Lorente CatalàRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

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

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

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

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Efficacy of the intervention
Change of depression symtpmatology through the Patient Health Questionnaire-9 (PHQ-9) after the intervention.

Secondary Outcome Measures

Acceptability
Assesment of the usability, defined as the facility of use percibed by the users through the System Usability Scale.
Acceptability
Satisfaction of the online intervention through the Client Satisfaction Questionnaire (CSQ-1).
Adaptation
Assesment of the process of normalization of an intervention through the Normalization MeAsure Development Questionnaire (NoMAD).
Adoption, viability and fidelity
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
Assessment of the use of health and social services and other economical impacts thourgh the Client Service Receipt Inventory (CSRI).
Diagnostic Interview
Assessment of the diagnostic criteria included in the DSM-V.

Full Information

First Posted
December 14, 2021
Last Updated
June 27, 2022
Sponsor
Universitat Jaume I
Collaborators
Instituto de Salud Carlos III, Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital. ACIF/2020/332
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1. Study Identification

Unique Protocol Identification Number
NCT05294614
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Jaume I
Collaborators
Instituto de Salud Carlos III, Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital. ACIF/2020/332

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Depressive Symptoms, Depression
Keywords
Depressive disorder, Depression, Implementation, Evidence-based intervention, Online intervention, Psychological intervention, Primary care, Health care settings

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
Participant
Masking Description
The present work should be considered as a closed cohort study, 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. The design used for this study is composed by 3 sequences (3 different starts of the treatment phase). The assignment of each of the 6 participating centers (2 per each autonomous community) to one of the 3 sequences will be randomly performed. The established sequences look like: A B B B B B B B B C C C C C C A A B B B B B B B B C C C C C A A A B B B B B B B B B C C C C In these sequences A represent the control phase, B the treatment phase and the C the maintenance phase. Participants will be masked to the information related to the sequences that they will follow. The masking will be established according to the randomization applied to each center.
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A B B B B B B B B C C C C C C
Arm Type
Other
Arm 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.
Arm Title
A A B B B B B B B B C C C C C
Arm Type
Other
Arm 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.
Arm Title
A A A B B B B B B B B C C C C
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
"Sonreír es diveritdo" - Smiling is fun
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of the intervention
Description
Change of depression symtpmatology through the Patient Health Questionnaire-9 (PHQ-9) after the intervention.
Time Frame
Pre-intervention and immediately after the intervention
Secondary Outcome Measure Information:
Title
Acceptability
Description
Assesment of the usability, defined as the facility of use percibed by the users through the System Usability Scale.
Time Frame
Pre-intervention and immediately after the intervention
Title
Acceptability
Description
Satisfaction of the online intervention through the Client Satisfaction Questionnaire (CSQ-1).
Time Frame
Immediately after the intervention
Title
Adaptation
Description
Assesment of the process of normalization of an intervention through the Normalization MeAsure Development Questionnaire (NoMAD).
Time Frame
Pre-intervention, immediately after the intervention and follow-up
Title
Adoption, viability and fidelity
Description
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
Time Frame
Pre-intervention and immediately after the intervention
Title
Implementation costs
Description
Assessment of the use of health and social services and other economical impacts thourgh the Client Service Receipt Inventory (CSRI).
Time Frame
Pre-intervention and immediately after the intervention AND follow-up
Title
Diagnostic Interview
Description
Assessment of the diagnostic criteria included in the DSM-V.
Time Frame
Pre-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosa Lorente Català
Phone
0034691527941
Email
rlorente@uji.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azucena García Palacios
Organizational Affiliation
University Jaume I
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier García Campayo
Organizational Affiliation
Institute of Health Research of Aragon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margalida Gili
Organizational Affiliation
Research Institute of Health Sciences, University of Balearic Islands, Palma de Mallorca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fermín Mayoral Cleries
Organizational Affiliation
University Regional Hospital of Malaga
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rosa Lorente Català
City
Castellón De La Plana
State/Province
Castellón
ZIP/Postal Code
12071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Lorente Català, Psychology
Phone
0034691527941
Email
rlorente@uji.es
First Name & Middle Initial & Last Name & Degree
Azucena García Palacios, Psychology
Email
azucena@uji.es

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
31133899
Citation
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Results Reference
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28241025
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Implementation of a Psychological Online Intervention for Low to Moderate Depression in Primary Health Care

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