Feasibility and Clinical Utility Study of the Unified Protocol for Group Treatment of Emotional Disorders in Penitentiary Facilities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5)
时间窗: Only before of the treatment to check inclusion criteria
Diagnostic interview to determine if the participant has a clinical diagnosis of emotional disorder (ET) and can be part of the study. The following diagnoses according to the DSM-V are included within the category of emotional disorder: major depressive disorder, dysthymic disorder, panic disorder, agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder, post-traumatic stress disorder, social anxiety disorder, hypochondria, and adjustment disorders. Patients with anxiety disorders not otherwise specified and those with depressive disorders not otherwise specified will also be included in the study.
General Depression Severity and Interference Scale (ODSIS)
时间窗: Up to 6 months follow-up
Severity of depressive symptoms; 5 items with 5-point Likert scale ranging from 0 (I did not feel depressed) to 4 (constant depression). Higher scores are associated with greater depressive symptomatology and interference.
General Severity and Interference Scale for Anxiety (OASIS)
时间窗: Up to 6 months follow-up
Severity of anxiety symptoms; 5 items with 5-point Likert scale ranging from 0 (I did not feel anxious) to 4 (constant anxiety). Higher scores are associated with greater anxiety symptomatology and interference.
Multidimensional Inventory for Emotional Disorders (MEDI)
时间窗: Up to 6 months follow-up
Evaluation through 49 items of the transdiagnostic profile of Emotional Disorders, which is composed of nine dimensions: neurotic temperament, positive temperament, depressed mood, somatic anxiety, arousal activation, social anxiety, intrusive cognitions, traumatic re-experiencing, and avoidance
次要结局
- Emotional Regulation Difficulties Scale (DERS)(Up to 6 months follow-up)
- EuroQol(Up to 6 months follow-up)
- The EuroQol Visual Analog Scale (VAS)(Up to 6 months follow-up)
- Satisfaction with Treatment Questionnaire (STQ) An adaptation of Client Satisfaction Questionnaire (CSQ-8)(Up to 6 months follow-up)
研究者
Óscar Peris Baquero
Principal Investigator
Instituto de Investigación Sanitaria Aragón
