Transdiagnostic Treatment of Emotional Disorders for Women in a Homeless Situation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- Universidad Complutense de Madrid
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in the Beck Depression Inventory (BDI-II) (Beck, Steer, & Brown, 1990); Spanish adaptation (Sanz, Navarro, & Vázquez, 2003) at pre, post intervention and at 3, 6 and 9 month follow-ups.
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of this study is to assess the effectiveness and feasibility of an adaptation of the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders to women living homeless in Madrid, Spain. To address this goal, both clinical and psychosocial outcomes will be measured. The application of the UP is postulated as an effective tool for improving mental health and well-being of women in a homeless situation, which in turn will enhance their social inclusion process.
Detailed Description
The European Strategy for the Homeless People states that homelessness is the most extreme form of poverty and exclusion, which violates human dignity and poses a risk to health and life. Women constitute a particularly vulnerable subgroup among homeless people. Women living homeless show significant deterioration in their psychological welfare and mental health, which, among other aspects, is an obstacle in the access to care resources and inclusion processes. 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Being a woman.
- •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 with a severe mental disorder in active phase (i.e. schizophrenia, bipolar disorder or an organic mental disorder).
- •Being diagnosed a severe cognitive deterioration.
- •Being under alcohol or substance effects when the pre-assessment is carried out.
Outcomes
Primary Outcomes
Change in the Beck Depression Inventory (BDI-II) (Beck, Steer, & Brown, 1990); Spanish adaptation (Sanz, Navarro, & Vázquez, 2003) at pre, post intervention and at 3, 6 and 9 month follow-ups.
Time Frame: Up to 9 months
The BDI-II is a 21-item self-report measure designed to assess depression severity. Each item is rated from 0 to 3 with a total score of a maximum of 63 points. The Spanish version has shown good internal consistency (α = 0.86).
Change in the Beck Anxiety Inventory (BAI) (Beck, & Steer, 1993); Spanish adaptation (Magán, Sanz, & García-Vera, 2008) at pre, post intervention and at 3, 6 and 9 month follow-ups.
Time Frame: Up to 9 months
The BAI is a 21-item self-report measure designed to assess anxiety severity. Each item has a 4-point severity scale (e.g., not at all, mildly, moderately, and severely), addressing symptoms experienced during the past week. The internal consistency of the Spanish version has been found to range from .85 to .94.
Secondary Outcomes
- Change in the Pemberton Happiness Index (PHI) (Hervás & Vázquez, 2013) at pre, post intervention and at 3, 6 and 9 month follow-ups(Up to 9 months)
- Change in the Social Support Questionnaire (SSQ) (Sarason, Sarason, Shearin, & Pierce, 1987); Spanish adaptation (Martínez-López et al., 2014) at pre, post intervention and at 3, 6 and 9 month follow-ups.(Up to 9 months)
- Change in Positive and Negative Affect Schedule (PANAS) (Watson, Clarck, & Tellegen, 1988); Spanish adaptation (López-Gómez, Hervás, & Vázquez, 2015) at pre, post intervention and at 3, 6 and 9 month follow-ups(Up to 9 months)
- Overall Anxiety Severity and Impairment Scale (OASIS) (Norman, Cissell, Means-Christensen, & Stein, 2006); Spanish version (González-Robles et al., 2018) at intersession assessment(Up to 3 months)
- Change in the Short-Form Health Survey Health Questionnaire (SF-12) (Ware, Kosinski, & Keller, 1996); Spanish adaptation (Vilagut et al., 2008) at pre, post intervention and at 3, 6 and 9 month follow-ups(Up to 9 months)
- Change in the Satisfaction with Life Domain Scale (SLDS) (Baker e Intagliatta, 1982); Spanish version by Muñoz, Panadero, & Rodríguez (2010) at pre, post intervention and at 3, 6 and 9 month follow-ups.(Up to 9 months)
- Overall Depression Severity and Impairment Scale (ODSIS) (Bentley, Gallagher, Carl, Barlow, 2014); Spanish version (Mira et al., 2019) at intersession assessment(Up to 3 months)