Unified Protocol in Penitentiary Facilities

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto de Investigación Sanitaria Aragón

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Unified Protocol

    Behavioral

    The Unified Protocol (UP) is a transdiagnostic, emotion-focused cognitive-behavioral treatment designed to address a range of emotional disorders, including anxiety, depression, and related conditions. It targets core mechanisms such as emotional avoidance, cognitive rigidity, and maladaptive emotion regulation strategies. The UP consists of structured modules focused on increasing emotional awareness, cognitive flexibility, and exposure to emotionally evocative situations. By addressing common underlying processes across disorders, the UP enhances treatment efficiency and applicability in both individual and group formats. Its flexibility makes it suitable for diverse populations and settings, including community and clinical contexts.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Unified Protocol in group formatExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5)

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.

Time frame
Only before of the treatment to check inclusion criteria
2

General Depression Severity and Interference Scale (ODSIS)

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.

Time frame
Up to 6 months follow-up
3

General Severity and Interference Scale for Anxiety (OASIS)

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.

Time frame
Up to 6 months follow-up
4

Multidimensional Inventory for Emotional Disorders (MEDI)

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

Time frame
Up to 6 months follow-up

Secondary outcomes

1

Emotional Regulation Difficulties Scale (DERS)

The evaluation is conducted through 28 items assessing difficulties in emotional regulation, divided into 5 subscales: lack of control, rejection, interference, inattention, and emotional confusion. Scores range from 1 (almost never) to 5 (almost always), with higher scores being associated with greater difficulties in emotional regulation.

Time frame
Up to 6 months follow-up
2

EuroQol

Quality of life is evaluated through 5 items assessing difficulties in mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Scores range from 1 (I do not have problems) to 3 (unable to perform these activities), with higher scores being associated with a worse quality of life.

Time frame
Up to 6 months follow-up
3

The EuroQol Visual Analog Scale (VAS)

The EuroQol Visual Analog Scale (VAS) assesses self-reported quality of life using a thermometer scale ranging from 0 (the worst imaginable health state) to 100 (the best imaginable health state).

Time frame
Up to 6 months follow-up
4

Satisfaction with Treatment Questionnaire (STQ) An adaptation of Client Satisfaction Questionnaire (CSQ-8)

Our adaptation includes 6 of the 8 items of the CSQ-8 (perceived quality, adequacy to previous expectations, recommendation of the treatment to friends or family, usefulness of the techniques learned, general satisfaction with the intervention and probability that they will choose an intervention of this type again) and one more item related to the discomfort generated by the intervention. Likewise, a change has been made in the Likert response scale from 4 points in the original (0 = "Bad / Not at all" to 4 = "Excellent/Very Much") to 11 in the current one (0 = "Bad / Not at all to 10 = "Excellent/Very Much").

Time frame
Up to 6 months follow-up

Other outcomes

1

Questionnaire on Sociodemographic Data (ad hoc)

Ad-hoc; Sex, age, marital status, number of sessions attended, and legal status of each participant.

Time frame
Baseline
2

Acceptability Questionnaire based on the TFA model

The Acceptability Questionnaire, based on the TFA model, consists of 7 items with a Likert-type response scale ranging from 1 (completely disagree, no effort, unsure, or unacceptable) to 5 (strongly agree, great effort, very sure, or completely acceptable). It evaluates the following dimensions: (1) Affective Attitude, assessing the extent to which participants liked or disliked using the UP; (2) Burden, measuring how much effort it cost to apply the UP; (3) Ethicality, evaluating whether there were any negative ethical or moral consequences of applying the UP; (4) Intervention Coherence, asking whether the approach of the UP to improve patients' emotional regulation made sense to the user; (5) Opportunity Costs, looking at whether the application of the UP interfered with other psychotherapy priorities; (6) Perceived Effectiveness, gauging how much the UP helped patients regulate their emotions; and (7) Self-efficacy, reflecting the degree of competence felt whe

Time frame
At the end of treatment (at 3 months)
3

Questionnaire on Intention to Use the UP in the Future and General Acceptability

The Questionnaire on Intention to Use the UP in the Future and General Acceptability includes an ad hoc question aimed at gauging participants' willingness to apply the UP again in the future. Specifically, for GHPs with experience in applying the UP, the question asks: To what extent would you accept applying it again? For participants with no prior experience, the question asks: To what extent would you accept using the UP? The response format is a 5-point Likert scale, ranging from 1 (never) to 5 (always). Higher scores are associated with greater general acceptability and a stronger intention to use the UP in the future.

Time frame
At the end of treatment (at 3 months)
4

Barriers to Implementation

The Barriers to Implementation Inventory (BTI) is a 39-item inventory designed to identify barriers to program implementation across four domains: equipment, administrative, theoretical/philosophical, and structural problems. Higher scores are associated with a greater number of barriers perceived during the implementation process.

Time frame
At the end of treatment (at 3 months)

Sponsors and contacts

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