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

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

Detailed Description
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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.

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

Conditions
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Depressive Disorder, Depressive Symptoms, Depression

Intervention / Treatment
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* Behavioral: Sonreír es diveritdo - Smiling is fun


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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: 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<br>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<br>* 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.<br>|
| Other: A A B B B B B B B B C C C C C<br>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<br>* 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.<br>|
| Other: A A A B B B B B B B B C C C C<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of 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 | 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 | Satisfaction of the online intervention through the Client Satisfaction Questionnaire (CSQ-1). | Immediately after the intervention | 
| Adaptation | 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 | 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 | 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 | Assessment of the diagnostic criteria included in the DSM-V. | Pre-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive disorder, Depression, Implementation, Evidence-based intervention, Online intervention, Psychological intervention, Primary care, Health care settings