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Unified Protocol in Penitentiary Facilities

I

Instituto de Investigación Sanitaria Aragón

Status

Not yet enrolling

Conditions

Emotional Disorder
Depression Disorders
Mood Disorders
Anxiety

Treatments

Behavioral: Unified Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT07070531
IPES/PU-CP/2025

Details and patient eligibility

About

Emotional disorders (EDs), which include anxiety disorders, unipolar mood disorders, and other related conditions, exhibit a high prevalence within prison populations, significantly exceeding that of the general population. Despite the high incidence of these disorders, the resources available for their treatment in correctional facilities are limited. The shortage of both human and material resources hinders inmates' access to quality mental health care.

In this context, the Unified Protocol (UP) for the transdiagnostic treatment of emotional disorders, a transdiagnostic intervention grounded in Cognitive Behavioral Therapy, has demonstrated effectiveness in addressing a variety of psychological problems across different contexts. It has also proven to be cost-effective, particularly when delivered in a group format. Therefore, implementing the UP in group format within correctional settings could represent a viable strategy to optimize limited resources and provide accessible and effective treatment to a larger number of inmates.

The primary objective of this pilot study is to evaluate the feasibility and clinical utility of the UP for the treatment of emotional disorders in prison environments. To this end, the UP will be delivered to approximately 25 participants, organized into groups of six to eight individuals, each receiving 12 weekly sessions lasting one hour. Follow-up assessments will be conducted at one, three, and six months after the intervention.

A mixed-methods approach will be employed to analyze the results, combining quantitative analyses to assess changes in emotional symptomatology and qualitative analyses to explore participant satisfaction and therapist acceptance. It is expected that participants will experience statistically significant improvements in emotional symptoms and that these improvements will be sustained over time, up to the six-month follow-up. It is also anticipated that participants will report a high level of satisfaction with the treatment. Furthermore, therapists are expected to evaluate the intervention positively and to identify potential barriers to its implementation.

The results of this pilot study will contribute to improving the feasibility and clinical utility of the UP in correctional settings, while also laying the groundwork for a future randomized controlled trial involving a larger number of facilities, participants, and therapists.

Full description

Prevalence of Mental Disorders in the Prison Population

According to the World Health Organization, mental disorders are the most prevalent health condition in European penitentiary institutions, affecting 32.8% of the incarcerated population, with incidence rates continuing to rise. This trend is corroborated by numerous studies that have long highlighted the high prevalence of mental disorders among inmates, significantly surpassing rates observed in the general population. For instance, common mental disorders (e.g., anxiety and mood disorders) are reported to be twice as prevalent, while severe mental disorders (e.g., personality or psychotic disorders) are up to four times more prevalent among the incarcerated population.

In Spain, the 2022 Survey on Health and Drug Use in the Inmate Population revealed that 42.3% of incarcerated women and 34.3% of incarcerated men have been diagnosed with a psychological disorder at some point in their lives. The study found prevalence rates of 18% for depression, 9.3% for personality disorders, and 5.6% for bipolar disorder. Similar results have been reported in other studies, where 14% of diagnoses among inmates were related to mood and/or anxiety disorders, with 80% of cases showing comorbidity with more than one diagnosis.

Conceptualization of Emotional Disorders and Emotion Dysregulation

Despite the diversity of disorders encompassed by anxiety and mood disorders and their differing clinical manifestations, scientific literature supports their grouping under a single category termed Emotional Disorders (EDs), which includes anxiety disorders, unipolar mood disorders, trauma- and stressor-related disorders, and obsessive-compulsive and related disorders. It has been suggested that these disorders share common etiological and maintenance mechanisms, such as neuroticism-defined as the trait tendency to experience frequent and intense negative emotions along with the perception of the world as dangerous/unpredictable -low extraversion, described as the tendency to engage with the environment with energy, joy, sociability, and confidence, and difficulties in emotion regulation, understood as the process by which an individual can influence the emotions they experience, how they experience them, and how and when they express them. Scientific evidence indicates that individuals with EDs exhibit deficits in emotion regulation and tend to engage in maladaptive emotion regulation behaviors, such as avoiding places, situations, sensations, or thoughts that are unpleasant, aiming to reduce emotional distress. While this may be effective in the short term by decreasing emotional discomfort, in the medium and long term, it not only fails to resolve the problem but also exacerbates and perpetuates it over time.

Mental Health Care in Spanish Prisons

Despite the high prevalence of mental disorders in this context, penitentiary centers have limited human and material resources. Specifically, in 2020, the estimated ratio of prison doctors per 1,000 inmates in Spain was 5.2, below the European average of 8.0 doctors per 1,000 inmates, according to WHO data. Similarly, the ratios of psychology or psychiatry professionals in penitentiary centers fall below international recommendations, with estimated ratios in 2020 of 0.8 psychiatric specialists per 100 individuals, significantly lower than in other European countries such as Germany, France, Italy, and the United Kingdom, where the ratio is estimated at around 5 specialists per 100 incarcerated individuals. Due to the high demand for psychological assistance and limited human resources, there is a need for brief, intensive, and evidence-based group interventions to address EDs in the penitentiary context.

Approach to Mental Health Issues in the Penitentiary System

The approach to penitentiary healthcare varies across different regions in Spain. Currently, the only autonomous communities with competencies in this area are Catalonia, the Basque Country, and the Chartered Community of Navarre. In the rest of the national territory, at the state level, this responsibility falls under the General Secretariat of Penitentiary Institutions.

Regarding strategies for the penitentiary treatment of mental health in Spain, individuals with psychological disorders who are deprived of their liberty can receive assistance through two resources: Psychiatric Penitentiary Hospitals (PPHs), institutions under the General Secretariat of Penitentiary Institutions offering treatment during incarceration, and ordinary penitentiary centers, which house 80% of inmates with mental disorders. In 2009, the Mental Illness Care Program in Prison (PAIEM) was introduced, available in 64 of the 66 ordinary centers under the Ministry of the Interior for inmates with Severe Mental Disorders. This program includes activities related to social skills promotion, self-care, improved self-control, psychoeducation, relapse prevention, and preparation for release, among others. In 2022, these interventions recorded a total of 1,817 participants, representing 4.45% of the total incarcerated population in the country.

In recent years, new models of mental health care have emerged, particularly in Catalonia, where the approach to this health issue in prisons occurs in three different areas: psychiatric units, outpatient care through the Primary Support Program (PSP), and care for individuals in third-degree through the Individualized Penitentiary Service Program (PSI). Despite these efforts, the high prevalence of mental disorders among inmates and the lack of resources significantly hinder the implementation of specific, evidence-based intervention programs.

Currently, various initiatives are being implemented to address some of the issues present in the prison population, such as self-harming behaviors. An example is the Systems Training for Emotional Predictability and Problem Solving (STEPPS) program, specifically designed to treat these behaviors. This group-based cognitive-behavioral therapeutic approach illustrates the feasibility of implementing structured group interventions in the penitentiary context.

However, given the high prevalence of EDs among inmates and the comorbidity present in these disorders, it is necessary to develop and implement transdiagnostic interventions aimed at improving emotion regulation skills across all EDs, not solely those exhibiting self-harming behaviors.

Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders and Intervention Formats

The categorical classification model of mental disorders has facilitated the development of various evidence-based psychological treatments targeting specific clinical syndromes described in the DSM or ICD manuals. Despite the benefits achieved thus far, psychopathological and clinical studies have highlighted the existence of shared etiological and maintenance mechanisms across different disorders and disorder groups, leading to the transdiagnostic approach. The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is a manualized transdiagnostic intervention based on Cognitive Behavioral Therapy, focusing on addressing the etiological and maintenance mechanisms of EDs, such as neuroticism, worry, rumination, and emotion dysregulation, among others. The UP consists of eight modules that include training in five key emotion regulation skills: mindfulness, cognitive flexibility, counteracting emotion-driven behaviors, interoceptive exposure, and emotional exposure. Its modular nature enhances flexibility and adaptability to various clinical problems (e.g., women in fertility units or as a preventive measure for EDs in university students) and allows for cost-effective applications, such as group formats. To date, several systematic reviews and meta-analyses have supported the efficacy of the UP in treating individuals diagnosed with EDs, considering it a treatment of choice for these disorders.

In Spain, our research team has led a line of investigation focused on the evaluation, diagnosis, and treatment of EDs through the UP. In our country, the UP has proven to be an effective and cost-efficient intervention for treating EDs when applied in group format within specialized mental health units of the Public Health System. Specifically, in a multicenter randomized clinical trial involving 533 participants diagnosed with EDs, the UP was administered in 12 two-hour weekly sessions. The study's results indicated that changes in the UP treatment condition were comparable to those achieved with treatment as usual (non-structured individual cognitive-behavioral therapy), with greater improvements observed in depression, anxiety symptoms, and quality of life. Furthermore, the improvements in the UP condition were sustained over time (up to 12 months post-treatment), despite the intervention being delivered intensively over approximately three months, reflecting its long-term efficacy. Additionally, the project's findings demonstrated that, in the long term (12-month follow-up), the cost of treatment in the UP condition was lower than in the treatment-as-usual condition (€161.74, SD = 34.09, range €95.92-€299.75 vs. €183.50, SD = 77.52, range €71.94-€335.72, respectively), and high levels of participant satisfaction and strong acceptability among clinical professionals in public mental health units were also observed.

Finally, the UP has also been adapted to treat severe mental disorders, such as bipolar disorder and psychotic spectrum disorders. In the latter case, our research team has demonstrated its efficacy in individuals at high risk for psychosis. Positive outcomes have also been observed in patients with treatment-resistant schizophrenia, self-injurious behaviors, and suicidal ideation. Although some of these studies are pilot or single-case designs, the encouraging results in emotional symptoms, emotion regulation, and quality of life suggest that the UP may be a useful and complementary intervention in addressing emotional dysregulation, especially in more severe disorders. This opens up doors for further investigation into its efficacy. However, to date, no studies have examined the feasibility of the UP in the prison setting.

Study Rationale

The high prevalence of emotional disorders, along with their comorbidity with other severe mental illnesses in the prison population, presents a significant challenge due to the limited human and material resources in penitentiary centers. In this regard, the UP has proven to be an effective intervention across various contexts and emotional problems. For this reason, implementing the UP in a group format for the treatment of emotional disorders in prison settings could optimize available resources and provide a comprehensive approach to emotional disorders, improving inmates' mental health, comorbid symptomatology, and quality of life. To our knowledge, this will be the first study to test the feasibility and clinical utility of the UP for the group-based treatment of emotional disorders in prison settings, and its findings will lay the groundwork for the development of future controlled clinical trials.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • At least one emotional disorder diagnosis (e.g., anxiety, depression, OCD, trauma-related, somatic, dissociative) based on the MINI interview
  • Comprehension of the intervention language (Spanish or Catalan)
  • Substance abstinence for more than 1 month
  • Voluntary participation and availability for all assessment and treatment sessions
  • Stable pharmacological treatment during the study unless medically contraindicated
  • Signed informed consent

Exclusion criteria

  • No emotional disorder diagnosis
  • Cognitive impairment or IQ <70 preventing comprehension
  • Diagnosis of a mental disorder incompatible with group formats (e.g., histrionic personality disorder)
  • Suicide risk at assessment
  • Legal status involving potential release or leave that could affect adherence

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Unified Protocol in group format
Experimental group
Description:
Participants will receive the intervention of the Unified Protocol (UP) in a group format, consisting of 12 sessions, one per week, each lasting 1 hour. Each session includes a review of previous content, resolution of doubts, and development of new material from one of eight modules. The program covers motivation for change, goal setting, understanding the adaptive function of emotions, emotional awareness and mindfulness, cognitive flexibility, problem solving, and addressing emotion-driven behaviors. Exposure to emotional and interoceptive experiences is introduced in later sessions. Follow-up sessions at 1, 3, and 6 months review progress, reinforce learning, identify risk signals, and promote relapse prevention and long-term well-being.
Treatment:
Behavioral: Unified Protocol

Trial contacts and locations

1

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Central trial contact

Óscar Peris Baquero, Phd

Data sourced from clinicaltrials.gov

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