Transdiagnostic Treatment of Emotional Disorders for Women in a Homeless Situation
NCT ID: NCT04392856
Last Updated: 2021-10-29
Study Results
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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TERMINATED
NA
100 participants
INTERVENTIONAL
2017-01-31
2021-06-30
Brief Summary
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Detailed Description
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There is a growing interest in the effectiveness and efficiency of intervention techniques to address mental health problems. The high comorbidity between mental health disorders, and especially emotional disorders, has promoted the development and consolidation of a transdiagnostic perspective. This perspective raises the existence of common mechanisms involved in the maintenance of different disorders, so that there would be a preamble to cognitive and/or behavioral processes shared by various psychological disorders. The design of a transdiagnostic treatment strategy allows a more inclusive approach to mental health and facilitates the design of similar treatment programs applicable to a wide range of mental disorders. Therefore, the transdiagnostic treatment could be a feasible and effective alternative to address some of the most common problems in mental health among women in a homeless situation. This approach could be useful to improve a diversity of symptoms in the own context of homeless living women and facilitate a systematic evaluation of its effectiveness.
The overall objective of this project is the development of a feasible and effective intervention adapted to the needs of women in a homeless situation and the service resources where they are attended. Moreover, the project aims to compare the group versus individual delivery of the UP among women in a homeless situation. This research is based on the hypothesis that the UP adaptation, both in group and individual delivery, will be effective in reducing anxiety and depression symptoms, decreasing negative affect and increasing psychological well-being, health state, positive affect, social support and quality of life. Strengths but also barriers and difficulties encountered in each format of intervention will be examined. This knowledge will be key to develop specific and adapted materials that enable effective interventions practices in the services resources for homeless people.
The UP intervention will consist of 12 weekly sessions lasting an hour and a half, applied in different centers for homeless people in Madrid. There will be several assessment moments: before the intervention, twelve intersession assessments (i.e., one per session), after the intervention, and 3 months, 6 months and 9 months follow-ups. The psychological intervention will be carried out by therapists with a background in psychology.
With this research it is expected to achieve results with impact at the technical level (in the design of effective interventions for psychological treatment of women in a homeless situation), on a scientific level (expanding knowledge about the effectiveness of intervention programs for women in social exclusion situations), and, especially, at the social level (affecting the quality of life and the processes of social inclusion of women in a homeless situation).
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
This research is composed by two sequential studies. The first study will deliver the UP in a group format, while the second study will deliver the UP on a one-to-one basis. Since these studies will not be performed concurrently, women will be assigned within each study to intervention or control condition. In the first study, participants will be assigned to one of two conditions: experimental condition (Unified Protocol, UP in group delivery) or waitlist control condition (WLC). In the second study, participants will be assigned to one of two conditions: experimental condition (Unified Protocol, UP in individual delivery) or control condition (WLC).
TREATMENT
SINGLE
Study Groups
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Unified Protocol Transdiagnostic Treatment Emotional Disorders
An adaptation of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) to women in a homeless situation will be implemented in public shelters setting in Madrid, Spain.
The UP adaptation is an intervention based protocol for emotional disorders, consisted of 12 treatment sessions of one and a half hours of duration each, at a rate of one per week.
Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)
The Spanish Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders for Homeless Women. The protocol contains five modules: (1) mindful emotion awareness, (2) cognitive flexibility, (3) countering emotional behaviors, (4) recognizing and confronting physical sensations, and (5) emotion exposures. This adaptation of Unified Protocol is organized in twelve sessions: Emotional disorders and emotional regulation; Motivation for change; Understanding the role of emotions; Mindful emotion awareness, Cognitive flexibility, Understanding and confronting physical sensations, Countering emotional behaviors, Emotional avoidance, Emotion exposure; Achievement recognition and look to the future; and Relapse prevention and closure.
Waitlist Control condition
The participants assigned to the waitlist control condition will not immediately receive the intervention. They will wait for 3 months, which is the duration of the intervention in the experimental group. After that time, they will be offered the same psychological treatment as those assigned to the UP (experimental condition).
Same than experimental condition (UP), after it finishes
The Spanish Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders for Homeless Women. The protocol contains five modules: (1) mindful emotion awareness, (2) cognitive flexibility, (3) countering emotional behaviors, (4) recognizing and confronting physical sensations, and (5) emotion exposures. This adaptation of Unified Protocol is organized in twelve sessions: Emotional disorders and emotional regulation; Motivation for change; Understanding the role of emotions; Mindful emotion awareness, Cognitive flexibility, Understanding and confronting physical sensations, Countering emotional behaviors, Emotional avoidance, Emotion exposure; Achievement recognition and look to the future; and Relapse prevention and closure.
Interventions
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Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)
The Spanish Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders for Homeless Women. The protocol contains five modules: (1) mindful emotion awareness, (2) cognitive flexibility, (3) countering emotional behaviors, (4) recognizing and confronting physical sensations, and (5) emotion exposures. This adaptation of Unified Protocol is organized in twelve sessions: Emotional disorders and emotional regulation; Motivation for change; Understanding the role of emotions; Mindful emotion awareness, Cognitive flexibility, Understanding and confronting physical sensations, Countering emotional behaviors, Emotional avoidance, Emotion exposure; Achievement recognition and look to the future; and Relapse prevention and closure.
Same than experimental condition (UP), after it finishes
The Spanish Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders for Homeless Women. The protocol contains five modules: (1) mindful emotion awareness, (2) cognitive flexibility, (3) countering emotional behaviors, (4) recognizing and confronting physical sensations, and (5) emotion exposures. This adaptation of Unified Protocol is organized in twelve sessions: Emotional disorders and emotional regulation; Motivation for change; Understanding the role of emotions; Mindful emotion awareness, Cognitive flexibility, Understanding and confronting physical sensations, Countering emotional behaviors, Emotional avoidance, Emotion exposure; Achievement recognition and look to the future; and Relapse prevention and closure.
Eligibility Criteria
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Inclusion Criteria
* Being aged over 18 years old.
* Providing written, informed consent.
* The participant is fluent in the language in which the treatment and evaluation are performed (i.e. Spanish).
* Being able to attend to the evaluation and treatment sessions
* Having access to the shelters where the intervention will be carried out.
Exclusion Criteria
* Being diagnosed a severe cognitive deterioration.
* Being under alcohol or substance effects when the pre-assessment is carried out.
18 Years
FEMALE
No
Sponsors
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Ministerio de EconomÃa y Competitividad, Spain
OTHER_GOV
University of Alcala
OTHER
Council of Madrid
UNKNOWN
Universidad Complutense de Madrid
OTHER
Responsible Party
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Principal Investigators
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Sonia Panadero, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Complutense de Madrid
Locations
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Faculty of Psychology. Complutense University of Madrid
Madrid, , Spain
Countries
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References
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Marin C, Guillen AI, Rodriguez-Moreno S, Dieguez S, Panadero S, Farchione T. Application of the unified protocol for transdiagnostic treatment of emotional disorders among homeless women: A feasibility study. Psychotherapy (Chic). 2021 Jun;58(2):242-247. doi: 10.1037/pst0000357. Epub 2021 Feb 4.
Other Identifiers
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FEM2016-75317-R
Identifier Type: -
Identifier Source: org_study_id