Online Multi-component Psychological Intervention for Depression, Anxiety and Well-being in 7 Countries

Study Overview
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Brief Summary
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This study evaluates the effectiveness of an online Multi-component psychological intervention, that is focused on providing self-support to the population of 5 Latin American countries and 2 European Countries. The objectives of the intervention are: 1) To reduce the symptoms of anxiety and depression in the adult population, 2) To increase the levels of subjective well-being.

Detailed Description
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Anxiety and depression at clinically significant levels are associated with suicidal thoughts and behaviors. Furthermore, it is associated with the health-disease process in two ways: 1) variables that influence behavior, hindering people's healthy habits and promoting the development of unhealthy behaviors; 2) anxiety and depression affect the psycho physiological activation of people, which affects their immune system. Considering the damage that can occur by not addressing incipient problems of anxiety and depression, it is important to develop interventions with preventive purposes. Thus, the online modality of the intervention presented in this project can benefit a significant number of people in Mexico, Ecuador, Chile, Brazil, Peru, the Netherlands and Spain. The online modality of psychological interventions is a viable treatment alternative, especially for those people who do not have any psychological treatment within their reach. The participants will be measured at pre, middle treatment, post assessment and two follow ups of 3 and 6 months. The self-report measures will include the following Psychometrics: General Anxiety Disorder with 7-items (GAD-7) Center for Epidemiologic Studies Depression Scale in its revised version (CESD-R). Perceived Stress Scale (PSS-10) Pittsburgh Sleep Quality scale (PSQI) Action Acceptance Questionnaire II (AAQ-II) The Satisfaction with Life scale The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) Perceived Deficits Questionnaire (PDQ-5) The Positive and Negative Affect Schedule (PANAS) Opinion on the treatment. System usability scale. Client Satisfaction Questionnaire (CSQ-8S) The Telehealth Usability Questionnaire (TUQ)

Official Title
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Well-being Online: Internet-based Self-administered Intervention to Reduce Anxiety and Depression Symptomatology: Randomized Clinical Trial in 7 Countries

Conditions
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Anxiety, Depression, Wellbeing, Stress

Intervention / Treatment
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* Behavioral: Well-being online


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Completion of 100% of the basal evaluation through the form Residence in one of the countries participating in the study Fluency/ proficiency in Spanish (Mexico, Ecuador, Chile, Peru and Spain), Dutch or English (Netherlands) or Portuguese (Brazil), depending on the country. Exclusion Criteria: Participants with severe symptoms of anxiety and/or depression, or they report a diagnosis of a depression and/or an anxiety disorder. Participants who self-report having another diagnosed psychiatric comorbidity: personality disorder, psychotic disorder, bipolar disorder, Attention-Deficit/Hyperactivity Disorder, or others. Participants taking medication for symptoms of depression and/or anxiety

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Well-being Online study will implement a randomized controlled trial at five points for the intervention groups and six evaluation periods for the control group: 1)pretest, 2)middle of the treatment, 3) post-test, 4) follow up at 3 months and 5) follow up at six months. 6) Participants in the control group will be re-assigned to the intervention group after the post-waiting list period. The study will implement a three-arm design (parallel group), comparing: Interactive Intervention Group , Intervention delivered through PDF files. Control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive intervention<br>The participants will receive a self-applied intervention composed by 10 sessions following a multi component structure. The participants assigned to this condition will count with interactive resources such as Videos, Online Forum and Exercises embedded on the platform. | Behavioral: Well-being online<br>* Multi component Intervention composed 10 sessions following a structure based on Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Positive Psychology (PP), Mindfulness and Behavioral Activation Therapy (BAT).<br>|
| Experimental: non-interactive intervention<br>Self-administered treatment with 10 sessions will be provided through care manuals in PDF format within the same web platform. Participants in this group will receive a manual within the platform with the same content of the sessions as the experimental group but in PDF format. | Behavioral: Well-being online<br>* Multi component Intervention composed 10 sessions following a structure based on Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Positive Psychology (PP), Mindfulness and Behavioral Activation Therapy (BAT).<br>|
| No Intervention: Waiting List group<br>The control condition consists of a 30-day waiting list, in which participants will not be able to access the interventions. After the waiting process, they will be given access to either the interactive intervention or the non-interactive intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in the scores of the Center for Epidemiologic Studies Depression (CESD-R) scale | Center for Epidemiologic Studies Depression (CES-D) is a structured self-report scale for evaluation depression symptoms. This scale assesses the number of depression symptoms within 2 weeks. The scale consists 20 items and contains 4-point score responses (0 to 3) as the following; rarely or none of the time (less than 1 day); some of a little of the time (1-2 days); occasionally or moderate amount of time (3-4 days) and most or all of the time (5-7 days). The total possible range of scores is from 0 to 60 where ^16 is the cut-off point for this scale, and higher scores indicate more symptoms of depression. It is expected a statistically significant decrease (P < 0.05) in depression symptoms. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules | 
| Decrease in the score of the General Anxiety Disorder with 7-items (GAD-7) scale | Is a short scale with items that measure the severity of generalized anxiety disorder symptoms. Responses are based on symptoms perceived during the past week. The questions of this scale are answered in Likert format with 0-3, where the maximum total score is 21. A score between 0 and 4 points indicates that anxiety is not perceived, and a score between 15 and 21 is an indicator of perceived severe anxiety.It is expected a statistically significant decrease (P < 0.05) in anxiety symptoms. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules | 
| Increase in Mental Psychological Well-being, the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) | It consists of 14 items, including hedonic (i.e. affects, life satisfaction) and eudaimonic (i.e. positive relationships, psychological functioning) items, which together measure mental well-being. Each item is responded in a Likert scale (i.e. 1 = none of the time to 5 = all of the time) and the total score ranges from 14 to 70. The higher the score, the higher the mental well-being | Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in The Perceived Stress Scale (PSS-10) | The PSS-10 has ten items with 5 response options (0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Often, 4 = Very often). The interpretation is that the higher the score, the higher the stress level | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules | 
| Decrease in the score of The Pittsburgh Sleep Quality Index | This instrument assesses the quality patterns of sleep. It differentiates the poor and good sleep by measuring seven areas, where the range score of answers are from 0 to 3, the global sum of this scale can be a value between 0 to 60, and the cutoff point is 5 that indicates a poor sleep quality. It is expected a statistically significant increase (P < 0.05) in the Sleep Quality measure. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules | 
| Decrease in the Action Acceptance Questionnaire II (AAQ-II) | The instrument measures experiential avoidance and psychological inflexibility. It consists of 7 items that are answered using a 7-point Likert scale. The items ask about the unwillingness to experience unwanted emotions and thoughts (e.g., I am afraid of my feelings, I worry about not being able to control my worries and feelings) and the inability to be in the present moment. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules | 
| Increase in The Satisfaction with Life scale | It consists of 5 items in which participants must indicate how much they agree with each question, with a response option in Likert format from 1 (strongly disagree) to 7 (strongly agree). The scores range from 5 to 35, where higher scores indicate greater satisfaction with life. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules | 
| Decrease in the Perceived Deficits Questionnaire or PDQ-5 | The scale asks about problems of functioning in daily life associated with possible cognitive problems, with a 5-point Likert-type response format, ranging from 1- Rarely to 5-Always. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules | 
| Decrease negative affect in the Positive and Negative Affect Schedule (PANAS) | PANAS comprises two groups consisting of ten terms of either positive or negative affect. Partcipants assess their intensity on a 5-point scale ranging from not at all to extremely, indicating the range of emotions at a given moment or over a period of time, and their chronic or transient nature. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules | 
| Increase positive affect in the Positive and Negative Affect Schedule (PANAS) | PANAS comprises two groups consisting of ten terms of either positive or negative affect. Partcipants assess their intensity on a 5-point scale ranging from not at all to extremely, indicating the range of emotions at a given moment or over a period of time, and their chronic or transient nature. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules |