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

Studies

Study First Submitted Date 2022-07-14
Study First Posted Date 2022-10-06
Last Update Posted Date 2023-05-11
Start Month Year October 2023
Primary Completion Month Year June 2025
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-11

Detailed Descriptions

Sequence: 20594070
Description 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).

Conditions

Sequence: 51843324 Sequence: 51843325
Name Anxiety Disorders Name Depressive Disorders
Downcase Name anxiety disorders Downcase Name depressive disorders

Id Information

Sequence: 39896662
Id Source org_study_id
Id Value UJaumeI_Transd_Group_Blended_2

Design Groups

Sequence: 55269023 Sequence: 55269024
Group Type Experimental Group Type Active Comparator
Title Blended group transversal protocol (BLGr-TP) Title Face-to-face group transversal protocol (FFGr-TP)
Description Treatment protocol based on the transdiagnostic perspective administered in blended (face-to-face + online) and group format. It consists of the following components: Psychoeducation about emotional disorders and emotion regulation; Motivation for change; Psychoeducation about emotions; Awareness of emotional experiences; Promotion of cognitive flexibility; Psychoeducation and awareness of avoidance strategies that maintain emotional problems; Interoceptive exposure: exposure to physical sensations; Situational and emotional exposure; Learning to move on; Learning to enjoy; Learning to live; Living and learning; Relapse prevention. Description Treatment protocol based on the transdiagnostic perspective administered in traditional (face-to-face) group format. It consists of the following components: Psychoeducation about emotional disorders and emotion regulation; Motivation for change; Psychoeducation about emotions; Awareness of emotional experiences; Promotion of cognitive flexibility; Psychoeducation and awareness of avoidance strategies that maintain emotional problems; Interoceptive exposure: exposure to physical sensations; Situational and emotional exposure; Learning to move on; Learning to enjoy; Learning to live; Living and learning; Relapse prevention.

Interventions

Sequence: 52164117 Sequence: 52164118
Intervention Type Behavioral Intervention Type Behavioral
Name Blended group transversal protocol (BLGr-TP) Name Face-to-face group transversal protocol (FFGr-TP)
Description 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 of the treatment (self-applied Online Transversal Protocol) will consist in working the contents exposed in the face-to-face sessions during between-sessions period (2 weeks). It is an interactive program with multimedia elements (videos, images,…) that allows people to perform the modules from home and at their own pace. In addition, the program is characterized by its ease of use, presenting an agile navigation. Description 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 in the face-to-face sessions through tasks for home (traditional paper format).

Keywords

Sequence: 79335046 Sequence: 79335044 Sequence: 79335045 Sequence: 79335047 Sequence: 79335048
Name Blended CBT Name Cognitive-Behavioral Therapy Name Transdiagnostic CBT Name Group CBT Name Emotional disorders
Downcase Name blended cbt Downcase Name cognitive-behavioral therapy Downcase Name transdiagnostic cbt Downcase Name group cbt Downcase Name emotional disorders

Design Outcomes

Sequence: 176316063 Sequence: 176316064 Sequence: 176316065 Sequence: 176316066 Sequence: 176316067 Sequence: 176316068 Sequence: 176316069 Sequence: 176316070 Sequence: 176316071 Sequence: 176316072
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other
Measure 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. Measure 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. Measure 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. Measure 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. Measure 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. Measure 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. Measure 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. Measure Score on the Expectations scale (adapted from Borkovec & Nau, 1972). Measure Score on the Opinion scale (adapted from Borkovec & Nau, 1972). Measure Score on the System Usability Scale (SUS) (Bangor, Kortum & Miller, 2008; Brooke, 1996).
Time Frame Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) Time Frame Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) Time Frame Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) Time Frame Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) Time Frame Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) Time Frame Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) Time Frame Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) Time Frame Pre-treatment Time Frame Post-treatment (4 months) Time Frame Post-treatment (4 months)
Description 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 (α = 0.80), test-retest reliability, and convergent and discriminant validity. The Spanish version has shown good internal consistency (α = 0.86), and convergent and discriminant validity. Description 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 (α = 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 (α = 0.93), as well as convergent and discriminant validity. Description 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 (α between .84 and .90) and convergent and discriminant validity. The Spanish version has demonstrated good to excellent internal consistency (α = .89 and .91 for PA and NA in women, respectively, and α = .87 and .89 for PA and NA in men, respectively) in college students. Description 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. Description 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. Description 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. Description 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 (α = 0.70 to 0.94), test-retest reliability, and sensitivity to change. The Spanish version has demonstrated excellent internal consistency and good concurrent validity. Description 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. Description 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. Description 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.

Browse Conditions

Sequence: 192164571 Sequence: 192164572 Sequence: 192164573 Sequence: 192164574
Mesh Term Depressive Disorder Mesh Term Anxiety Disorders Mesh Term Mood Disorders Mesh Term Mental Disorders
Downcase Mesh Term depressive disorder Downcase Mesh Term anxiety disorders Downcase Mesh Term mood disorders Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48015706
Agency Class OTHER
Lead Or Collaborator lead
Name Universitat Jaume I

Overall Officials

Sequence: 29094184 Sequence: 29094185 Sequence: 29094186 Sequence: 29094187
Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Study Director
Name Amanda Díaz-García, Dr. Name Noelia Jiménez-Orenga, PhD student Name Juana María Bretón-López, Dr. Name Azucena García-Palacios, Dr.
Affiliation University of Zaragoza, Teruel Campus Affiliation Jaume I University, Castellón, Spain Affiliation Jaume I University, Castellón, Spain Affiliation Jaume I University, Castellón, Spain

Central Contacts

Sequence: 11941486 Sequence: 11941487
Contact Type primary Contact Type backup
Name Juana María Bretón-López, Dr. Name Azucena García-Palacios, Dr.
Phone +34 964387642 Phone +34 964387640
Email breton@uji.es Email azucena@uji.es
Phone Extension 7642 Phone Extension 7640
Role Contact Role Contact

Design Group Interventions

Sequence: 67754674 Sequence: 67754675
Design Group Id 55269023 Design Group Id 55269024
Intervention Id 52164117 Intervention Id 52164118

Eligibilities

Sequence: 30573577
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria 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).
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254292058
Registered In Calendar Year 2022
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 5
Number Of Other Outcomes To Measure 3

Designs

Sequence: 30321788
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26515744 Sequence: 26515745
Intervention Id 52164117 Intervention Id 52164118
Name BLGr-TP Name FFGr-TP

Links

Sequence: 4359898
Url http://psicologiaytecnologia.labpsitec.es/
Description Web platform of self-applied treatment

Responsible Parties

Sequence: 28700507
Responsible Party Type Sponsor

Study References

Sequence: 51737450 Sequence: 51737445 Sequence: 51737446 Sequence: 51737447 Sequence: 51737448 Sequence: 51737449 Sequence: 51737451 Sequence: 51737452 Sequence: 51737453 Sequence: 51737454 Sequence: 51737455 Sequence: 51737456 Sequence: 51737457 Sequence: 51737458 Sequence: 51737459 Sequence: 51737460 Sequence: 51737461 Sequence: 51737462 Sequence: 51737463 Sequence: 51737464 Sequence: 51737465 Sequence: 51737466 Sequence: 51737467 Sequence: 51737468 Sequence: 51737469
Pmid 29422409 Pmid 24708078 Pmid 19719339 Pmid 18486238 Pmid 29215315 Pmid 32039720 Pmid 33520670 Pmid 30508459 Pmid 30383797 Pmid 26535048 Pmid 25326035 Pmid 21208350 Pmid 10830568 Pmid 31024352 Pmid 11983645 Pmid 11497032 Pmid 3397865
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation 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. Citation 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. Citation 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. Citation 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 Citation 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. Citation Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260. Citation 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. Citation 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. Citation Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlof E. Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2018 Jan;47(1):1-18. doi: 10.1080/16506073.2017.1401115. Epub 2017 Dec 7. Citation Costa, P. T. & McCrae, R. R. (1992). Normal personality assessment in clinical practice: the NEO personality inventory. Psychol. Assess., 4(1), 5-13. Citation Diaz-Garcia A, Gonzalez-Robles A, Mor S, Mira A, Quero S, Garcia-Palacios A, Banos RM, Botella C. Positive and Negative Affect Schedule (PANAS): psychometric properties of the online Spanish version in a clinical sample with emotional disorders. BMC Psychiatry. 2020 Feb 10;20(1):56. doi: 10.1186/s12888-020-2472-1. Citation Diaz-Garcia A, Gonzalez-Robles A, Garcia-Palacios A, Fernandez-Felipe I, Tur C, Castilla D, Botella C. Blended transdiagnostic group CBT for emotional disorders: A feasibility trial protocol. Internet Interv. 2021 Jan 7;23:100363. doi: 10.1016/j.invent.2021.100363. eCollection 2021 Mar. Citation Echezarraga A, Calvete E, Las Hayas C. Validation of the Spanish Version of the Work and Social Adjustment Scale in a Sample of Individuals With Bipolar Disorder. J Psychosoc Nurs Ment Health Serv. 2019 May 1;57(5):44-51. doi: 10.3928/02793695-20181128-02. Epub 2018 Dec 4. Citation Gonzalez-Robles A, Mira A, Miguel C, Molinari G, Diaz-Garcia A, Garcia-Palacios A, Breton-Lopez JM, Quero S, Banos RM, Botella C. A brief online transdiagnostic measure: Psychometric properties of the Overall Anxiety Severity and Impairment Scale (OASIS) among Spanish patients with emotional disorders. 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J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.