An interventional study of Well-being online in Anxiety, Depression and Wellbeing, sponsored by Universidad Internacional de Valencia. Status unknown at 8 sites in 6 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Universidad Internacional de Valencia · Not applicable, Interventional, and Treatment
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.
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:
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 200 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Universidad Internacional de Valencia is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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).
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.
Time frame: 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.
Time frame: 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: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
Plan to share: Yes — The information will be available in a private server or in a server of the journal(s) that we will publish the articles that will be the result of this study. The protocol of the study is currently in progress to be published, in this article will be included such study protocol, the informed consent is already shared in the register of clinical trials.
Supporting information: Icf
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Universidad Internacional de Valencia