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Trial record 9 of 21 for:    "Depressive Disorder" [DISEASE] AND Behavioral AND Spanish | ( Map: Spain )

Feasibility of a Group Blended Transdiagnostic CBT Protocol for Emotional Disorders

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ClinicalTrials.gov Identifier: NCT04008576
Recruitment Status : Not yet recruiting
First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Universitat Jaume I

Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 4, 2019
Last Update Posted Date July 4, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Change in the Beck Anxiety Inventory (BAI) (Beck, & Steer, 1990; Magán, Sanz, & García-Vera, 2008) at pre-, post-treatment, and at 3-month follow-up. [ Time Frame: Pre-treatment, Post treatment (4 months), follow-up (7 months). ]
    The BAI is a 21-item self-report measure designed to assess anxiety. Each item has a 4-point Severity scale (e.g., not at all, mildly, moderately, and severely) that addresses symptoms experienced during the past week. The internal consistency of the BAI has been found to range from .85 to .94.
  • Change in the Beck Depression Inventory (BDI-II) (Beck, Steer, & Brown, 1990; Sanz, Navarro, & Vázquez, 2003) at pre-, post-treatment, and at 3-month follow-up. [ Time Frame: Pre-treatment, Post treatment (4 months), follow-up (7 months). ]
    It is one of the most widely used questionnaires to evaluate depression severity in pharmacological and psychotherapy trials. It consists of 21 items about the different symptoms characterizing major depression disorder, added together to obtain the total score, which can be a maximum of 63 points. The instrument has good internal consistency (α = 0.76 to 0.95). The Spanish version of this instrument has also shown a high internal consistency for both general (α = 0.87) and clinical populations (α = .89).
  • Change in the Positive and Negative Affect Schedule (PANAS) (Watson, Clark, & Tellegen, 1988; Sandín et al., 1999) at pre-, post-treatment, and at 3-month follow-up. [ Time Frame: Pre-treatment, Post treatment (4 months), follow-up (7 months). ]
    The PANAS consists of 20 items that evaluate two independent dimensions: positive affect and negative affect. 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Change in the Overall Anxiety Severity and Impairment Scale (OASIS) (Campbell-Sills et al., 2009; González-Robles et al., 2018) at pre-, post-treatment, and at 3-month follow-up. [ Time Frame: Pre-treatment, Post treatment (4 months), follow-up (7 months). ]
    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.
  • Change in the Overall Depression Severity and Impairment Scale (ODSIS) (Bentley et al., 2014; Mira et al., 2019) at pre-, post-treatment, and at 3-month follow-up. [ Time Frame: Pre-treatment, Post treatment (4 months), follow-up (7 months). ]
    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.
  • Change in the NEO-five factor Inventory (NEO-FFI) (Costa & McCrae, 1992; Robins, Fraley, Roberts, & Trzesniewski, 2001; Aluja, García, Rossier, & García, 2005) at pre-, post-treatment, and at 3-month follow-up. [ Time Frame: Pre-treatment, Post treatment (4 months), follow-up (7 months). ]
    The NEO FFI is the short version of the NEO-PI-R [88], 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.
  • Change in the Quality of Life Index (QLI) (Mezzich, Cohen, Ruiperez, Banzato, & Zapata-Vega, 2011; Mezzich et al., 2000) at pre-, post-treatment, and at 3-month follow-up. [ Time Frame: Pre-treatment, Post treatment (4 months), follow-up (7 months). ]
    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.
  • Score on the Work and Social Adjustment Scale (WSAS) (Echezarraga, Calvete, & Las Hayas, 2018; Mundt, Marks, Shear, & Greist, 2002) [ Time Frame: Pre-treatment, Post treatment (4 months), follow-up (7 months). ]
    The WSAS assesses the degree of interference associated with the patients' symptoms in five areas: work, home management, private leisure, social leisure, and family relationships. The questionnaire has 5 items rated on a scale from 0 (not at all) to 8 (very severely). Higher scores indicate greater interference in the different areas.
  • Score on the Expectations scale and the Opinion scale (adapted from Borkovec & Nau, 1972) [ Time Frame: Pre-treatment, post-treatment (4 months). ]
    Each 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. The Opinion scale is administered when the patient has completed the treatment, and its aim is to assess satisfaction with this treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of a Group Blended Transdiagnostic CBT Protocol for Emotional Disorders
Official Title  ICMJE Feasibility of a Group Blended Transdiagnostic Cognitive-behavior Therapy Protocol for the Treatment of Emotional Disorders
Brief Summary The aim of this study is to analyze the feasibility of a blended transdiagnostic group protocol for the treatment of depression and anxiety disorders (emotional disorders) in a one-group clinical trial.
Detailed Description

Emotional disorders are the most prevalent mental disorders and they affect the lives of millions of people across the globe. There is an important body of research showing the efficacy of cognitive-behavioral treatments (CBT) for anxiety and depressive disorders (emotional disorders). However, the dissemination and implementation of evidence-based CBT is still one of the principal challenges for research and clinical practice. Over the past two decades, different approaches on how to improve the dissemination and implementation of evidence-based treatments have emerged. In this sense, one important line of research is the transdiagnostic approach to the treatment of emotional disorders. Transdiagnostic treatments "apply the same underlying treatment principles across mental disorders, without tailoring the protocol to specific diagnoses". Broadly, transdiagnostic treatments are based on the premise that the commonalities of psychological disorders outweigh their differences, and that the observed differences (symptoms) are specific manifestations of broader, underlying common psychopathological processes. A number of meta-analyses have shown the efficacy of transdiagnostic treatments. This approach has implications for treatment and clinical practice. For instance, comorbid presentations can be targeted more appropriately, and the costs of training are lower because only one protocol is needed for a range of disorders. Traditionally, transdiagnostic treatments have focused on the regulation of negative affect or neuroticism and less attention has been paid to the regulation of positive affect. However, more recent approaches have emerged that acknowledge the importance of targeting positive affect in addition to negative affect to improve treatment outcomes. Our research group has developed a transdiagnostic protocol that incorporates a component for the regulation of positive affect, with results that support its efficacy in a sample of community patients.

Another approach that could enhance the dissemination and implementation of evidence-based CBT as well as considerably reduce the costs is the use of the Internet to deliver treatments. A number of systematic reviews have shown that Internet-delivered treatments are effective and that they work as effectively as face-to-face psychotherapy. In the context of Internet-delivered treatments, one possibility is the combination of face-to-face and Internet-delivered therapy, also known as blended treatments. The main advantage of blended treatments is its lower cost in comparison with traditional face-to-face psychotherapy. Moreover, blended treatments might be a good alternative for those patients less likely to benefit from guided or unguided Internet-delivered treatments (with no face-to-face contact). On the other hand, group psychotherapy can also help to reduce the costs of therapy. The literature has shown that there are no differences between individual and group CBT for anxiety and depressive disorders.

In spite of the advantages of group CBT, in the specific field of transdiagnostic treatments, research has mainly focused on individual transdiagnostic treatments. Moreover, to our knowledge, no studies have been published that combine blended and group delivery formats to provide transdiagnostic treatments for emotional disorders. The combination of these two treatment approaches to deliver a transdiagnostic treatment might be a highly cost-effective treatment strategy for these disorders. This ultimately could contribute to the dissemination and implementation of evidence-based transdiagnostic CBT.

The goal of this pilot study is to conduct a feasibility trial to study a blended transdiagnostic group protocol for the treatment of emotional disorders in a pilot study. The treatment is a transdiagnostic CBT protocol with strategies for the regulation of both negative and positive affectivity

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety Disorders
  • Depressive Disorder
Intervention  ICMJE Behavioral: Group Blended Transdiagnostic treatment
The treatment combines group face-to-face and Internet-delivered psychotherapy: 7 group sessions delivered every 3 weeks plus the use of an online treatment platform between sessions. Its goal is to learn and practice adaptive regulation strategies from a mechanistically transdiagnostic approach, with a focus on both negative and positive affectivity. Each group session will focus on one of the following core components: the first group session will focus on CBT traditional strategies such as motivation for change and psychoeducation about emotions; sessions 2 to 5 will focus on strategies to down-regulate negative affect: present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion-driven behaviors, and interoceptive and situation-based emotion exposure; session 6 will focus on strategies to regulate positive affect; the final session will teach relapse prevention techniques. All the treatment components are delivered in 16 online treatment modules.
Study Arms  ICMJE Group Blended Transdiagnostic treatment
Intervention: Behavioral: Group Blended Transdiagnostic treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 years old or older
  • DSM-IV diagnosis of emotional disorder (panic disorder, agoraphobia, generalized anxiety disorder, social anxiety disorder, major depressive disorder, dysthymic disorder, depression not otherwise specified, anxiety not otherwise specified, obsessive-compulsive disorder)
  • Fluent in Spanish
  • Daily access to the Internet at home; email address

Exclusion Criteria:

  • Diagnosis of a severe mental disorder (schizophrenia, bipolar disorder, substance/alcohol use disorder)
  • High risk of suicide
  • Receiving another psychological treatment during the study period
  • Changes and/or increases in pharmacological treatment during the study period (a decrease is accepted)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Azucena García-Palacios, Dr +34 964387640 ext 7640 azucena@uji.es
Contact: Cristina Botella, Dr +34 964387639 ext 7639 botella@uji.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04008576
Other Study ID Numbers  ICMJE UJaumeI_Transd_Group_Blended
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data will be available after deidentification.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: The data will be available immediately following publication.
Access Criteria: The data will be available to anyone who wishes to access them.
Responsible Party Universitat Jaume I
Study Sponsor  ICMJE Universitat Jaume I
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alberto González-Robles, Dr Universitat Jaume I
Principal Investigator: Amanda Díaz-García, Dr Universitat Jaume I
PRS Account Universitat Jaume I
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP