Anxiety Disorders Clinical Trial
Official title:
Efficacy of a Group Treatment Based on Transdiagnostic Perspective for Emotional Disorders and Applied in Blended Format: a Randomized Controlled Trial.
This study will consist in a randomized controlled clinical trial (RCT) to test the efficacy of a blended group transversal protocol (BLGr-TP) compared to a face-to-face group transversal protocol (FFGr-TP). The main aims of the study are the following: - To analyze the differential efficacy of the BLGr-TP versus the FFGr-TP for the treatment of emotional disorders in aspects of clinical measures, as well as in terms of retention and dropout rate and adherence. - To analyze the differential acceptability of the BLGr-TP versus the FFGr-TP for the treatment of emotional disorders. In addition, it is intended to carry out a study of mediators and moderators of the efficacy of both interventions. The established hypotheses in relation to the main goals are: - Both treatment modalities (FFGr-TP and BLGr-TP) will achieve improvements in the symptoms of emotional disorders, reflected in the scores of the clinical measures. - The BLGr-TP will show equivalent efficacy to the FFGr-TP. - The BLGr-TP will show an acceptability comparable to the face-to-face protocol. Both modalities will be well valued by the participants. - In both treatment modalities, the changes achieved are expected to be maintained over time (3, 6 and 12 months).
Status | Not yet recruiting |
Enrollment | 144 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Being 18 years old or more. - DSM-5 (APA, 1013) diagnostic criteria for emotional disorder (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, major depressive disorder, dysthymia, obsessive-compulsive disorder, non-specified anxiety disorder, non-specified depressive disorder). - Good understanding of Spanish. - Access to the Internet and email address. - Informed consent to participate. Exclusion Criteria: - Diagnosis of a severe mental disorder (psychotic disorder, bipolar disorder, substance and/or alcohol dependence). - High risk of suicide. - Having a serious medical illness or other condition that prevents treatment from being carried out. - Receiving another psychological treatment during the study period. - Changes and/or increases in pharmacological treatment during the study period (a decrease is accepted). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universitat Jaume I |
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Score on the Expectations scale (adapted from Borkovec & Nau, 1972). | This scale is made up of five items, rated on a scale from 0 (nothing at all) to 10 (completely), that cover how logical the treatment seems to be, to what extent it could satisfy the patient, whether it could be recommended to a person with the same problem, whether it could be used to treat other psychological problems, and its usefulness for the patient's problem. The Expectation Scale is applied once the treatment rationale has been explained. Its aim is to measure subjective patient expectations about this treatment. | Pre-treatment | |
Other | Score on the Opinion scale (adapted from Borkovec & Nau, 1972). | This scale is made up of five items, rated on a scale from 0 (nothing at all) to 10 (completely), that cover how logical the treatment seems to be, to what extent it could satisfy the patient, whether it could be recommended to a person with the same problem, whether it could be used to treat other psychological problems, and its usefulness for the patient's problem. The Opinion Scale is administered when the patient has completed the treatment, and its aim is to assess satisfaction with this treatment. | Post-treatment (4 months) | |
Other | Score on the System Usability Scale (SUS) (Bangor, Kortum & Miller, 2008; Brooke, 1996). | The SUS is applied in order to assess the usability of a service or product and the acceptance of technology by the people who use it. The SUS is a simple, ten-item scale that indicates the degree of agreement or disagreement with the statements on a 5-point scale (1 = strongly disagree, 5 = strongly agree). The final score is obtained by adding the scores on each item and multiplying the result by 2.5. Scores range from 0 to 100, where higher scores indicate better usability. | Post-treatment (4 months) | |
Primary | Change in the Overall Anxiety Severity and Impairment Scale (OASIS) (Campbell-Sills et al., 2009; González-Robles et al., 2018) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The OASIS is a 5-item self-report scale that evaluates the frequency and severity of anxiety symptoms, the functional impairment related to these symptoms (i.e. school, work, home, or social impairment), and behavioral avoidance. Each item instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4, added together to obtain a total score ranging from 0 to 20. Previous studies have shown good internal consistency (a = 0.80), test-retest reliability, and convergent and discriminant validity. The Spanish version has shown good internal consistency (a = 0.86), and convergent and discriminant validity. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | |
Primary | Change in the Overall Depression Severity and Impairment Scale (ODSIS) (Bentley et al., 2014; Mira et al., 2019) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The ODSIS is a brief self-reported scale with 5 items that assess the severity and functional impairment associated with depressive symptoms. Items are coded on a 5-point scale (0-4). The sum of the scores is used to obtain the total score, which can be a maximum of 20. The measure has shown excellent internal consistency (a = 0.94 in an outpatient sample, 0.92 in a community sample, and 0.91 in a student sample) and good convergent/discriminant validity. The Spanish validation has excellent internal consistency (a = 0.93), as well as convergent and discriminant validity. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | |
Secondary | Change in the Positive and Negative Affect Schedule (PANAS) (Watson, Clark & Tellegen, 1988; Sandín et al., 1999; Díaz-García et al., 2020) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). It contains 10 descriptors evaluating PA (e.g., "enthusiastic", "inspired", "proud") and 10 others assessing NA (e.g., "scared", "irritable", "guilty"). The range for each scale (10 items on each) is from 10 to 50, and the patient has to answer how he or she usually feels regarding each of these emotions. The scale showed excellent internal consistency (a between .84 and .90) and convergent and discriminant validity. The Spanish version has demonstrated good to excellent internal consistency (a = .89 and .91 for PA and NA in women, respectively, and a = .87 and .89 for PA and NA in men, respectively) in college students. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | |
Secondary | Change in the Difficulties in Emotion Regulation Scale (DERS) (Gratz & Roemer, 2004; Hervás & Jódar, 2008) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The DERS is a self-report scale that assesses different clinically relevant aspects of maladaptive emotional regulation and the main difficulties that may arise in the processing of emotions. In the Spanish adaptation of the scale, the factorial analysis showed five interpretable factors, one less than the original scale: Emotional lack of control (Impulsivity and No strategies of the original scale), Emotional rejection (No acceptance), Everyday interference (No goals), Emotional inattention (No awareness) and Emotional confusion (No clarity). The Spanish validation consists of 28 items with a 5-point Likert scale, being 1 = Almost never (0-10% of the time) and 5 = Almost always (90-100% of the time). The adapted scale has good psychometric properties: internal consistency of 0.93, test-retest reliability of 0.74 and good convergent and incremental validity. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | |
Secondary | Change in the NEO-Five Factor Inventory (NEO-FFI) (Costa & McCrae, 1992; Robins, Fraley, Roberts & Trzesniewski, 2001; Aluja, García, Rossier & García, 2005) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The NEO-FFI is the short version of the NEO-PI-R, designed to assess the five personality dimensions through 60 items. In this study, only the subscales of neuroticism and extraversion are used. Each scale contained 12 items with a five-point Likert response format. Two-week retest reliability is uniformly high, ranging from 0.86 to 0.90 for the five scales, and internal consistency ranges from 0.68 to 0.86. The Spanish version of the NEO-FFI has been found to be appropriate. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | |
Secondary | Change in the Quality of Life Index (QLI) (Mezzich, Cohen, Ruiperez, Benzato & Zapata-Vega, 2011; Mezzich et al., 2000) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The QLI is a self-report questionnaire that consists of 10 items aimed at assessing quality of life in ten areas: psychological well-being, physical well-being, emotional and social support, interpersonal functioning, selfcare and independent functioning, community and service support, occupational functioning, self-realization, spiritual satisfaction, and an overall assessment of quality of life. The Spanish version of the QLI has shown good internal consistency and test-retest reliability in previous studies. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | |
Secondary | 7. Change in the Work and Social Adjustment Scale (WSAS) (Echezarraga et al., 2018; Mundt et al., 2002) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The WSAS is a 5-item scale that evaluates the degree of interference associated with the patients' symptoms in the following five domains: work, home management, private leisure, social leisure, and family relationships. Items are coded on a scale from 0 (not at all) to 8 (very severely), and higher scores are indicative of greater interference in the different areas. The scale has shown good to excellent internal consistency (a = 0.70 to 0.94), test-retest reliability, and sensitivity to change. The Spanish version has demonstrated excellent internal consistency and good concurrent validity. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) |
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