Up-regulating Positive Affect in Emotional Disorders

NCT02790398 | Completed

• 1 other identifier: UJaumeI_Transd_PS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Depression

Keywords

Transdiagnostic treatment protocol; Transdiagnostic treatment protocol + PA component

Outcome Measures

Primary Outcomes (1)

• Change in the Positive and Negative Affect Scale (PANAS) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.

  The PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). The range for each scale (10 items on each) is from 10 to 50. The Spanish version has demonstrated high internal consistency (α = 0.89 and 0.91 for PA and NA in women, respectively, and α = 0.87 and 0.89 for PA and NA in men, respectively) in college students.

  Up to 7 months

Secondary Outcomes (3)

• Change in the Beck Depression Inventory II (BDI-II) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.

  Up to 7 months

• Change in the Overall Anxiety Severity and Impairment Scale (OASIS) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.

  Up to 7 months

• Change in the Quality of Life Inventory (QLI) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.

  Up to 7 months

Study Arms (2)

Transdiagnostic treatment protocol

EXPERIMENTAL

Transdiagnostic treatment protocol.

Behavioral: Transdiagnostic treatment protocol

Transdiagnostic treatment protocol + PA regulation component

ACTIVE COMPARATOR

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

Behavioral: Transdiagnostic treatment protocol + PA regulation component

Interventions

Transdiagnostic treatment protocol 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

Transdiagnostic treatment protocol + PA regulation component 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.

Transdiagnostic treatment protocol + PA regulation component

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

University Jaume I

Castellon, Castellón, 12071, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Alberto Gonzalez-Robles, PhD student

  Universitat Juame I

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 3, 2016
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 30, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)