Transdiagnostic Treatment of Emotional Disorders for Women in a Homeless Situation

NCT04392856 | Terminated

• 1 other identifier: FEM2016-75317-R
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Keywords

Unified Protocol; Transdiagnostic approach; Homelessness

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Up to 9 months

• 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.

  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.

  Up to 9 months

Secondary Outcomes (7)

• 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

• 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 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 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 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

Other Outcomes (2)

• Alcohol Use Disorders Identification Test (AUDIT) (Saunders et al. 1993); Spanish adaptation (Rubio, Bermejo, Caballero, & Santo Domingo, 1998).

  Up to 9 months

• Drug Abuse Screening Test (DAST-10) (Skinner, 1982); Spanish adaptation (Pérez-Gálvez et al., 2010)

  Up to 9 months

Study Arms (2)

Unified Protocol Transdiagnostic Treatment Emotional Disorders

EXPERIMENTAL

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.

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

Waitlist Control condition

OTHER

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).

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

Interventions

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) BEHAVIORAL

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.

Unified Protocol Transdiagnostic Treatment Emotional Disorders

Same than experimental condition (UP), after it finishes BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Ministerio de Economía y Competitividad, Spain: collaborator
• University of Alcala: collaborator
• Council of Madrid: collaborator

Study Sites (1)

Faculty of Psychology. Complutense University of Madrid

Madrid, 28223, Spain

Location

Related Publications (1)

• 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.

  PMID: 33539144 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Sonia Panadero, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will know if they are assigned to the treatment condition or to the WLC group. Shelter professionals and researchers will know the condition of each participant, however, independent evaluators will not know whether the woman is in UP or Waitlist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All women in a homeless situation attending any of the collaborating shelters will be asked to participate in the present study. Once inclusion criteria are met, each participant will be assigned to experimental condition or control condition. 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).

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: January 1, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 29, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)