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Up-regulating Positive Affect in Emotional Disorders

NCT ID: NCT02790398

Last Updated: 2016-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-03-31

Brief Summary

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The aim of this study is to assess the differential effect of two transdiagnostic treatment protocols for emotional disorders (ED) (depression and anxiety disorders) using a randomized pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified Protocol; and b) a version of this protocol that also includes a specific component to address the regulation of positive affect (TTP+PA). Another aim was to assess the acceptability of both treatments by patients. It was hypothesized that the intervention would result in significant differences in favor of the TTP+PA protocol in all measures. Regarding acceptability, it was hypothesized that both treatments (TP and TP+PA) would be well-accepted by the two groups of participants.

Detailed Description

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ED are highly prevalent mental disorders and one of the main causes of disability worldwide. Currently, there is evidence showing the efficacy of transdiagnostic treatments for anxiety disorders, and for comorbid depression and anxiety disorders. An important line of research within the transdiagnostic treatment of ED was initiated by D. H. Barlow. Barlow's theory of triple vulnerability emphasizes the underlying vulnerabilities that are common to ED and help to explain the comorbidity among these diverse conditions. A central aspect within this theoretical perspective is the role of emotion regulation in ED. The regulation of negative emotions in ED has received a great deal of attention in cognitive behavior therapy (CBT) research, and more recently in transdiagnostic ED models like the UP developed by Barlow's team. However, although Barlow underscored the role of low PA in the onset and maintenance of ED, the main objective of the treatment components in the UP is to train patients in negative affect (NA) regulation, but less attention has been paid to the inclusion of treatment components to directly target PA regulation. Moreover, literature has shown that higher levels of PA are associated with better physical and psychological health, healthier lifestyles, and better general functioning. Consequently, an important treatment goal from a transdiagnostic treatment approach would be to increase PA while decreasing NA.

The aim of this study is to compare the differential effect of two transdiagnostic treatment protocols for ED using a randomized pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified Protocol; and b) a version of this protocol that also includes a specific component to address the regulation of positive affect (TTP+PA). Another aim is to assess the acceptability of both treatments by patients. It was hypothesized that the intervention would result in significant differences in favor of the TTP+PA protocol in all measures. Regarding acceptability, it was hypothesized that both treatments (TP and TP+PA) would be well-accepted by the two groups of participants.

Conditions

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Anxiety Depression

Keywords

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Transdiagnostic treatment protocol Transdiagnostic treatment protocol + PA component

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Transdiagnostic treatment protocol

Transdiagnostic treatment protocol.

Group Type EXPERIMENTAL

Transdiagnostic treatment protocol

Intervention Type BEHAVIORAL

Transdiagnostic treatment protocol for emotional disorders whose aims are to learn and practice adaptive ways to regulate emotions from a transdiagnostic perspective. The protocol contains the following components: present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion driven behaviors, interoceptive and situation-based emotion exposure, psychoeducation about emotions, motivational enhancement and relapse prevention. These components are organized in twelve modules.

Transdiagnostic treatment protocol + PA regulation component

Transdiagnostic treatment protocol that includes a component aimed at the regulation of PA.

Group Type ACTIVE_COMPARATOR

Transdiagnostic treatment protocol + PA regulation component

Intervention Type BEHAVIORAL

Transdiagnostic treatment protocol for emotional disorders + PA regulation components has the purpose of learning and practicing adaptive ways to regulate emotions from a transdiagnostic perspective. This protocol includes the same components but it also includes 4 additional modules focused specifically on the regulation of positive affectivity.

Interventions

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Transdiagnostic treatment protocol

Transdiagnostic treatment protocol for emotional disorders whose aims are to learn and practice adaptive ways to regulate emotions from a transdiagnostic perspective. The protocol contains the following components: present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion driven behaviors, interoceptive and situation-based emotion exposure, psychoeducation about emotions, motivational enhancement and relapse prevention. These components are organized in twelve modules.

Intervention Type BEHAVIORAL

Transdiagnostic treatment protocol + PA regulation component

Transdiagnostic treatment protocol for emotional disorders + PA regulation components has the purpose of learning and practicing adaptive ways to regulate emotions from a transdiagnostic perspective. This protocol includes the same components but it also includes 4 additional modules focused specifically on the regulation of positive affectivity.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years old or older
* meeting the DSM-IV diagnostic criteria for ED (major depression disorder, dysthimic disorder, generalized anxiety disorder, social anxiety disorder, panic disorder, agoraphobia, obsessive-compulsive disorder, anxiety disorder not otherwise specified, unipolar mood disorder not otherwise specified)
* ability to understand and read Spanish

Exclusion Criteria

* bipolar disorder
* schizophrenia
* risk of suicide
* receiving another psychological treatment during the study
* in the case of receiving pharmacological treatment, an increase and/or change in this treatment during the study period (a decrease in pharmacological treatment is accepted)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitat Jaume I

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alberto Gonzalez-Robles, PhD student

Role: STUDY_CHAIR

Universitat Juame I

Locations

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University Jaume I

Castellon, Castellón, Spain

Site Status

Countries

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Spain

Other Identifiers

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UJaumeI_Transd_PS

Identifier Type: -

Identifier Source: org_study_id