Transdiagnostic Treatment of Emotional Disorders for Women in a Homeless Situation (UPHW)

Universidad Complutense de Madrid

Status: Terminated

Conditions: Depression; Anxiety

Treatments: Behavioral: Same than experimental condition (UP), after it finishes; Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04392856

FEM2016-75317-R

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Unified Protocol Transdiagnostic Treatment Emotional Disorders

Experimental group

Description:

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.

Treatment:

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)

Waitlist Control condition

Other group

Description:

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).

Treatment:

Behavioral: Same than experimental condition (UP), after it finishes