Efficacy of a Transdiagnostic Group Treatment for Emotional Disorders Applied in Blended Format: a Controlled Study.

Официальное название

Efficacy of a Group Treatment Based on Transdiagnostic Perspective for Emotional Disorders and Applied in Blended Format: a Randomized Controlled Trial.

Обзор

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).

Подробное описание

Emotional disorders (ED) are among the most common and most disabling psychological disorders. They involve important costs and a high comorbidity between them. A large number of evidence-based treatment programs (EBT) has shown to be effective; however, there is a difficulty regarding their dissemination, being that it is difficult to train clinicians in the different protocols for different disorders, and a difficulty in the management of patients with comorbidity. The transdiagnostic approach and the incorporation of technologies for the administration of the based-Internet treatments can help to overcome these barriers. In this context, blended treatments, that combine face-to-face therapy with online therapy, are gaining prominence, because they exhibit advantages over traditional intervention and over treatments totally self-administered throughout Internet. Otherwise, the application of treatments in group format also allows to provide EBTs at a lower cost, so that both blended format and group format constitute strategies that allow improve the cost-effectiveness binomial. To our knowledge, no studies that integrate blended with group format for apply a transdiagnostic protocol for ED have been published.

This study will be a two-arm, parallel-group, randomized controlled clinical trial (RCT) in which participants will be randomly assigned to one of two conditions: 1) Face-to-face group transversal protocol (FFGr-TP) and 2) Blended group transversal protocol (BLGr-TP). To carry it out, a total of 144 patients will be needed. Randomization will be stratified by primary diagnosis. Block randomization will be performed within each stratum to ensure that all major diagnoses are equally represented under all conditions. In this trial there will be five evaluation moments: pre-treatment, post-treatment and follow-up at 3, at 6 and at 12 months. During the treatment administration, two messages of support (an email and a SMS) per week will be sent to participants.

The study will be carried out following national and international standards (Declaration of Helsinki and Tokyo, and Declaration of Madrid of the World Psychiatric Association) and has been submitted to the approval of the Research Ethics Committee of the Universitat Jaume I. Participants will be adult people who contact with the Psychological Assistance Service (PAS) of the Universitat Jaume I or who write at email enabled for the study. All participants will be volunteers and they will give their informed consent to participate in the study. The confidentiality and rights of the subjects included in the study will be guaranteed in accordance with the provisions of Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of the digital rights (LOPDgdd), which adapts Spanish legislation to the General Data Protection Regulation of the European Union (RGPD).

Вмешательства

• Поведенческое Blended group transversal protocol (BLGr-TP)
  It will consist in the administration of a transdiagnostic treatment protocol composed by 16 modules focused on regulating both negative and positive affect. The intervention will be administered over a 16-week period. Face-to-face group sessions will be combined with autonomous work of patients through a web platform where they will find the contents of the program. The groups will have 6-10 patients, who will attend a total of 8 face-to-face sessions of 2 hours long each one. The online part o
• Поведенческое Face-to-face group transversal protocol (FFGr-TP)
  It will consist in the administration of the transdiagnostic treatment protocol through the 16 modules focused on regulating both negative and positive affect. The intervention will be carried out in face-to-face group format and it will be administered during a 16-week period. The groups will have between 6 to 10 patients, who will attend a total of 16 face-to-face sessions of 2 hours long each one. During between-sessions period (1 week), patients will work the content of the modules exposed i

Первичные конечные точки

• 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-, 6- and 12-month follow-up. [Срок оценки: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)]
• 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-, 6- and 12-month follow-up. [Срок оценки: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)]

Вторичные конечные точки (8)

• 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-, 6- and 12-month follow-up. [Срок оценки: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)]
• Change in the Difficulties in Emotion Regulation Scale (DERS) (Gratz & Roemer, 2004; Hervás & Jódar, 2008) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up. [Срок оценки: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)]
• 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-treatmen,t and at 3-, 6- and 12-month follow-up. [Срок оценки: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)]
• 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-, 6- and 12-month follow-up. [Срок оценки: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)]
• 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-, 6- and 12-month follow-up. [Срок оценки: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)]
• Change on the Multidimensional Emotional Disorders Inventory (MEDI) (Rosellini & Brown, 2019; Osma et al., 2023) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up. [Срок оценки: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)]
• Change on the General Self-Efficacy Scale (GSES) (Baessler y Schwarzer, 1996; Sanjuán et al., 2000) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up. [Срок оценки: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)]
• Change on the Modulate Subscale of the S-DERS (Lavender et al., 2017). [Срок оценки: Throughout the treatment (post-modules measure)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Jaume I University, Castellón, Spain — Castellon

Публикации

• Aluja, A., García, O., Rossier, J., et al. (2005). Comparison of the NEO-FFI, the NEOFFI-R and an alternative short version of the NEO-PI-R (NEO-60) in Swiss and Spanish samples. Pers Individ Dif, 38(3), 591-604.
• Andrews G, Basu A, Cuijpers P, Craske MG, McEvoy P, English CL, Newby JM. Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: An updated meta-analysis. J Anxiety Disord. 2018 Apr;55:70-78. doi: 10.1016/j.janxdis.2018.01.001. Epub 2018 Feb 1. PMID 29422409
• Bangor, A., Kortum, P.T y Miller, J.T. (2008). An empirical evaluation of the System Usability Scale. International Journal of Human-Computer Interaction, 24(6), 574-594. https://doi.org/10.1080/10447310802205776
• Bentley KH, Gallagher MW, Carl JR, Barlow DH. Development and validation of the Overall Depression Severity and Impairment Scale. Psychol Assess. 2014 Sep;26(3):815-830. doi: 10.1037/a0036216. Epub 2014 Apr 7. PMID 24708078
• Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260.
• Brooke, J. (1996). SUS: A 'Quick and Dirty' Usability Scale. In P. W. Jordan, B. Thomas, I. L. McClelland & B. Weerdmeester (Eds.), Usability Evaluation in Industry. London, England: CRC Press.
• Brown TA, Barlow DH. A proposal for a dimensional classification system based on the shared features of the DSM-IV anxiety and mood disorders: implications for assessment and treatment. Psychol Assess. 2009 Sep;21(3):256-71. doi: 10.1037/a0016608. PMID 19719339
• Campbell-Sills L, Norman SB, Craske MG, Sullivan G, Lang AJ, Chavira DA, Bystritsky A, Sherbourne C, Roy-Byrne P, Stein MB. Validation of a brief measure of anxiety-related severity and impairment: the Overall Anxiety Severity and Impairment Scale (OASIS). J Affect Disord. 2009 Jan;112(1-3):92-101. doi: 10.1016/j.jad.2008.03.014. Epub 2008 May 16. PMID 18486238

Идентификаторы

NCT: NCT05569018 · UJaumeI_Transd_Group_Blended_2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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