Depression Clinical Trial
Official title:
Acceptability, Efficacy and Moderators of Clinical Change of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders in the Mexican Population: Randomized Controlled Trial
Emotional, trauma and stress-related disorders show high incidence, prevalence, morbidity, and comorbidity rates in Mexico. In recent decades, research findings indicate that cognitive behavioral interventions, from a disorder-specific perspective, are the effective front-line treatment for anxiety and depression care. However, these treatments are not often used. The reasons for this are: limited access and low availability to effective interventions; a minority of people actively seek psychological care because of their own distress condition, fearing social stigma, because of geographical reasons that separate them from health centers, because of time, preference for other treatment or self-help, for the high cost of treatment, which makes it inaccessible and unaffordable to both, the user, and the public health system. It has also been stated that the comorbidity between mental disorders, as well as the gap between research findings and clinical practice could influence the poor dissemination of effective treatments, resulting in a lack of up-to-date professionals providing relevant interventions. This has motivated the practice of some studies aimed at knowing the moderating, mediating variables and psychological mechanisms that improve the process of clinical change. Emotional deregulation of negative affection has been found to be a moderating factor and/or mediation in addressing emotional disorders from a transdiagnostic perspective, aimed at two or more specific disorders. In this way, transdiagnostic treatments could help overcome the drawbacks related to comorbidity between disorders. However, technological advancement has created alternatives for psychological assistance, highlighting the possibilities offered by technologies since Internet-supported interventions have been empirically tested for effectiveness, efficiency and this efficiency can be key to ensuring access to those who are inaccessible. Thus, the study aims to identify the indicators of efficacy, acceptability, and moderation of clinical change of a transdiagnostic intervention through a telepsychology platform for the treatment of emotional disorders and derived from stress and trauma.
Status | Not yet recruiting |
Enrollment | 153 |
Est. completion date | December 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: a) be of legal age; b) voluntarily participate in the study; c) meet diagnostic criteria for emotional disorders (anxiety or depression) in accordance with the International Neuropsychiatric Interview- Mini, version 5.0 (Sheehan et al., 2006), and show a score = 25 in Beck's Anxiety Depression Inventory (Beck & Steer,1990) and/or = 30 in the Beck-BDI-II Depression Inventory (Beck, Steer & Brown, 1996); d) have access to computer equipment with an Internet connection; e) have a valid email address; f) have basic digital skills in the use of an operating system and internet browsing. Exclusion Criteria: a) psychotic disorder; b) alcohol and drug abuse; c) have active suicidal ideation; d) medical condition whose severity or characteristics prevent the intervention; e) be receiving psychological and/or pharmacological treatment during the study. Elimination criteria : a) not accepting the conditions of informed consent and b) absence on web or mobile platform for more than 15 days or having missed two consecutive sessions of synchronous treatment sessions. |
Country | Name | City | State |
---|---|---|---|
Mexico | Comprehensive Mental Health Center, Ministry of Health of Tlaxcala | Chiautempan | Tlaxcala |
Mexico | Autonomous University of Ciudad Juarez | Ciudad Juárez | Chihuahua |
Mexico | Instituto Tecnológico de Sonora | Ciudad Obregón | Sonora |
Mexico | Faculty of Psychology, National Autonomous University of Mexico | Mexico City | |
Mexico | Autonomous University of Baja California | Tijuana | Baja California |
Mexico | Faculty of Higher Studies Iztacala, National Autonomous University of Mexico | Tlalnepantla | State Of Mexico, Mexico |
Lead Sponsor | Collaborator |
---|---|
Universidad Nacional Autonoma de Mexico | National Council of Science and Technology, Mexico |
Mexico,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease in the score of Beck Anxiety Inventory | Beck Anxiety Inventory (BAI , Beck & Steer, 1990). The BAI is a 21-item self-report measure of the severity of common affective, cognitive, and somatic symptoms of anxiety. Items have four response options ranging from 0 "not at all" to 3 "severely". The cut-off points are: 0-5 minimal anxiety, 6-15 mild anxiety, 16-30 moderate anxiety and 31-63 severe anxiety. High internal consistency and adequate construct validity, divergent and convergent for the Mexican version has been documented (Cronbach's alpha = .83) (Robles et al., 2001). | 9 weeks | |
Primary | Decrease in the score of Beck Depression Inventory | Beck Depression Inventory (BDI-II; Beck, Steer & Brown, 1996). It consists of 21 items that fundamentally evaluate the clinical symptoms of melancholy and the intrusive thoughts present in depression. Cronbach's alpha for version II (= .87-.92). Each statement has four response options that reflect increasing symptom frequency or severity. Total scores can range from 0-63 with the following cut-offs points: 0-13 minimally depressed, 14-19 mildly depressed, 20-28 moderately depressed, and 29-63 severely depressed. | 9 weeks | |
Primary | Decrease in the score of Post-Traumatic Stress Disorder Checklist | This instrument describes the symptoms of post-traumatic stress taking into consideration the diagnostic criteria of activation, alterations, avoidance and reexperimentation. It has 20 items that are scored on a Likert-type scale that goes from 0 (not at all) to 4 (totally). In its adaptation to the Mexican population, the psychometric properties of the scale show adequate internal consistency with an alpha of .97, as well as an appropriate convergent validity (rs = .58 to .88; Durón-Figueroa et al., 2019). Items are scored on a Likert scale ranging from 0 to 4, where higher scores indicate more pronounced PTSD symptoms. A cut-off score of 33 was suggested to have a partial diagnosis of PTSD. | 9 weeks | |
Primary | Decrease in the score of Scale of Difficulties in Emotional Regulation | Scale of Difficulties in Emotional Regulation (DERS; Gratz & Roemer, 2004). It is a self-applied instrument that measures two dimensions through 15 items, emotional regulation strategies and awareness of emotions. The version validated in Mexican population by De la Rosa et al. (2021), presents a Cronbach's Alpha valued between .84 - .74. | 9 weeks | |
Primary | Decrease frequency, severity and avoidance of anxiety | General Anxiety and the Impairment Severity Scale (OASIS) (Norman et al., 2011). It consists of 5 questions with a scale of 0 to 4, which measures frequency, severity and avoidance of anxiety in different fields: work / academic interference / family, and deterioration of social and daily life. It has good internal consistency (a = 0.80) and test-retest reliability (k = 0.82). The Spanish version confirmed the factorial structure, reliability and validity data obtained by the original authors: internal consistency in both populations, in general and clinical (a = 0.86) and test-fail reliability (k = 0.84) (Mira et al., 2015). | 9 weeks | |
Primary | Decrease frequency and severity of depression | General Depression and the Impairment Gravity Scale (ODSIS)(Bentley et al., 2014). This scale evaluates experiences related to depression. It consists of five items with different answer options ranging from 0 to 4 for each item. It measures the frequency and severity of depression, as well as the level of avoidance to work/academic/home interference, and social life. In the Spanish version, the internal consistency has proven to be excellent, with a Cronbach alpha between 0.91 and 0.94 and a good convergent and discriminatory validity (González-Robles et al., 2015). | 9 weeks | |
Secondary | Increase the level of acceptance and satisfaction of psychological treatment | Questionnaire with four questions that report the level of satisfaction with the treatment, if you would recommend the treatment to a friend or relative, is the treatment considered useful for your case and if you think that the treatment was difficult to handle or aversive. | 9 weeks |
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