AnxietyUPHWNCT04392856
Transdiagnostic Treatment of Emotional Disorders for Women in a Homeless Situation
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) and Same than experimental condition (UP), after it finishes in people with Anxiety and Depression, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) and Same than experimental condition (UP), after it finishes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2017to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Psychology. Complutense University of Madrid
Madrid, 28223
About this study
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.
Read the 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).
- Conditions
- Anxiety, Depression
- Being tested
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), Same than experimental condition (UP), after it finishes
- Keywords
- Unified Protocol, Transdiagnostic approach, Homelessness
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)Behavioural
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 finishesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Same than experimental condition (UP), after it finishes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
The PANAS is a 20-item self-report measure designed to assess negative and positive affect in the last week. Each item has a 5-point severity scale (e.g., not at all, mildly, moderately, quite a lot, and severely) with a total score from 20 to 100. The internal consistency of the Spanish version was .92 for positive affect subscale and .88 for negative affect subscale.
Measured: 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
The PHI is a 21-item measure designed to assess integrative well-being using a scale from 0 (fully disagree) to 10 (fully agree) in the first 11 items and dichotomy answers (yes/no) in the last 10 items. It includes two subscales: remember well-being (general, hedonic, eudaimonic, and social well-being) and experienced well-being. Cronbach´s alpha of Spanish version was .84.
Measured: 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
The SF-12 is a generic health status instrument with 12 items, and eight subscales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health). These eight subscales can be combined into two scores for physical health (PH) and mental health (MH), and a total score, ranged from 0 to 100, where higher scores reflect better self-reported health. The internal consistency of the Spanish version was α = .85 for PH and α = .78 for MH.
Measured: 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.
The SSQ is a 6 items measure of social support. It includes two scales: number and satisfaction with social support (on a scale ranging from 1 to 9). The Spanish version has shown good internal consistency for both dimensions (α = 0.90 and α = 0.93, respectively).
Measured: 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.
This questionnaire was adapted for use in rehabilitation centers for people with mental disorders by Muñoz et al. (2010). It is a 18-item self-report measure that was designed for assessing their actual satisfaction in various aspects of the life. An 8-point visual analog scale with faces is used.
Measured: 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
The ODSIS is a 5-item self-report measure that was designed for assessing the frequency and intensity of depression symptoms, the functional impairment related to these depressive symptoms, as well as behavioral avoidance across emotional disorders over the past week. Response items are coded from 0 to 4 and can be summed to obtain a total score ranging from 0 to 20. The internal consistency of the Spanish version was between .91 and .94.
Measured: Up to 3 months
Overall Anxiety Severity and Impairment Scale (OASIS) (Norman, Cissell, Means-Christensen, & Stein, 2006); Spanish version (González-Robles et al., 2018) at intersession assessment
The OASIS is a self-report questionnaire designed to evaluate the severity and functional impairment associated with anxiety. The scale presents five items with a 5-point likert scale ranging from 0 (I didn't feel anxious) to 4 (Constant anxiety). The total scale score, which ranges from 0 to 20, is obtained by summing all items. Cronbach's alpha of the Spanish version was 0.86.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study startJan 2017
- Primary completionJun 2021
- Study completionJun 2021
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, University of Alcala, Council of Madrid
- Responsible party
- Sponsor
- Investigators
- Sonia Panadero, PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392856
- Sponsor's protocol ID
- FEM2016-75317-R
- Acronym
- UPHW
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 29 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33539144
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Treatment of Emotional Disorders for Women in a Homeless Situation
- ClinicalTrials.gov ID
- NCT04392856
- Acronym / sponsor ID
- UPHW / FEM2016-75317-R
- Conditions
- Anxiety, Depression
- Keywords
- Unified Protocol, Transdiagnostic approach, Homelessness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, University of Alcala, Council of Madrid
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol Transdiagnostic Treatment Emotional Disorders | Experimental | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)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. |
| Waitlist Control condition | Other | Behavioral: Same than experimental condition (UP), after it finishesThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Unified Protocol Transdiagnostic Treatment Emotional Disorders |
| Same than experimental condition (UP), after it finishesThe 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. | Behavioural | Waitlist Control condition |
Primary outcome
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.
7 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to 3 months
Overall Anxiety Severity and Impairment Scale (OASIS) (Norman, Cissell, Means-Christensen, & Stein, 2006); Spanish version (González-Robles et al., 2018) at intersession assessment
Time frame: Up to 3 months
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Derived from this study: PubMed 33539144Marin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Panadero, PhD principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) and Same than experimental condition (UP), after it finishes in people with Anxiety and Depression, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.