Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06297460
Other study ID # STEPPSPENITENTIARY
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 1, 2025

Study information

Verified date March 2024
Source Universitat Jaume I
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall objective of this study is to assess the feasibility, within the Penitentiary Centers of Catalonia, of adapting the STEPPS program for addressing and preventing emotional dysregulation and self-harming behaviors through an implementation study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Men or women deprived of liberty serving sentences in a penitentiary center in Catalonia. - Presence of self-harming behaviors. - Sufficient understanding and proficiency in Spanish to participate in the STEPPS program. - Sufficient cognitive competence for study participation. - Mental capacity to provide informed consent. Exclusion Criteria: - Inmates under security measures or classified in the first degree of treatment. - Inmates with language difficulties. - Presence of severe pathologies that may hinder study participation. - Inmates with the possibility of imminent release, impending transfers to other penitentiary centers, or pending trial.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Systems Training for Emotional Predictability & Problem Solving (STEPPS)
STEPPS is based on a cognitive-behavioral and skills training approach divided into three major components. The first component (sessions: 1-2) teaches participants to replace misconceptions about the presented issues with greater awareness of thoughts, feelings, and behaviors that characterize them. It also helps them identify their own thought patterns driving their behaviors. The second (sessions 3-12) teaches skills to more effectively manage the cognitive and emotional effects of the issues, such as distancing, communication, challenging, distraction, and problem-solving. The third component (sessions 13-19) teaches behavioral skills where participants are encouraged to master habits of healthy eating, sleep hygiene, regular exercise, leisure activities, health monitoring, self-harm prevention, and interpersonal effectiveness. The therapeutic objectives of the three blocks are awareness of illness (1), emotional regulation (2), and behavioral regulation (3).

Locations

Country Name City State
Spain Rosa Castellón De La Plana Castellón

Sponsors (2)

Lead Sponsor Collaborator
Universitat Jaume I Centre d'Estudis i Formació Especialtzada Generalitat de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Arnau F, Garcia-Guerrero J, Benito A, Vera-Remartinez EJ, Baquero A, Haro G. Sociodemographic, Clinical, and Therapeutic Aspects of Penitentiary Psychiatric Consultation: Toward Integration Into the General Mental Health Services. J Forensic Sci. 2020 Jan;65(1):160-165. doi: 10.1111/1556-4029.14137. Epub 2019 Jul 25. — View Citation

Black DW, Blum N, Eichinger L, McCormick B, Allen J, Sieleni B. STEPPS: Systems Training for Emotional Predictability and Problem Solving in women offenders with borderline personality disorder in prison--a pilot study. CNS Spectr. 2008 Oct;13(10):881-6. doi: 10.1017/s1092852900016989. — View Citation

Black DW, Blum N, McCormick B, Allen J. Systems Training for Emotional Predictability and Problem Solving (STEPPS) group treatment for offenders with borderline personality disorder. J Nerv Ment Dis. 2013 Feb;201(2):124-9. doi: 10.1097/NMD.0b013e31827f6435. — View Citation

Brennan CA, Crosby H, Sass C, Farley KL, Bryant LD, Rodriquez-Lopez R, Romeu D, Mitchell E, House AO, Guthrie E. What helps people to reduce or stop self-harm? A systematic review and meta-synthesis of first-hand accounts. J Public Health (Oxf). 2023 Mar 14;45(1):154-161. doi: 10.1093/pubmed/fdac022. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Barriers and facilitators detected by professionals that are influencing the implementation process - Qualitative information Semi-structured interviews conducted to professionals guided by Consolidated Framework for Implementation Research (CFIR) (Damschroder et al., 2009).
To guide the development of these analyses, the CFIR served as a framework, assisting in semi-structured interviews and formulating relevant questions based on the five domains that influence the implementation process: (1) Intervention Characteristics, (2) Outer Setting, (3) Inner Setting, (4) Characteristics of Individuals, and (5) Implementation Process (25,33).
Inmediately after the intervention
Primary Level of emotional and behavioral disregulation of patients Using the Longitudinal assessment of the severity of emotional and behavioral dysregulation (Borderline Evaluation of Severity Over Time, BEST) (Blum et al., 2002), a 15-item questionnaire with a 5-point Likert scale (1= none/very mild; 5= extremely) that assesses three areas: the intensity of thoughts and emotions, and negative and positive behaviors. Pre-intervention and inmediately after the intervention
Secondary Type and levels of impulsivity of patients The Barratt Impulsiveness Scale (BIS) (Barratt, 1959) is a self-report questionnaire designed to assess impulsiveness in different areas. It consists of 30 items that are scored on a 4-point scale (from rarely or never (1) to always or almost always (4)). The scale measures three aspects of impulsiveness: Attentional Impulsiveness, Motor Impulsiveness, and Non-Planning Impulsiveness. Pre-intervention and inmediately after the intervention
Secondary Suicide risk of patients Using the Beck Suicidal Intent Scale (SIS) (Beck et al., 1979) it is assessed the characteristics and likelihood of a suicide attempt in the present and the past. It addresses circumstances during the attempt, attitudes towards life and death, thoughts before, during, and after the attempt, and substance use. The questionnaire consists of 20 items rated on a 3-point scale (0 to 2). Pre-intervention and inmediately after the intervention
Secondary Self-injury frequency, typology and funcionality of patients Through Inventory of Statements About Self-injury (ISAS) (Klonsky & Glenn, 2009), a questionnaire that explores self-injurious behaviors and is divided into two sections. The first section evaluates the presence and frequency of 13 different types of self-injuries, and the second section assesses the functionality of self-injurious behaviors on a 3-point Likert scale. Pre-intervention and inmediately after the intervention
Secondary Degree of hopeless of patients Using Beck Hopeless Scale (BHS) (Beck et al., 1974), a 20-item true/false scale that assesses individuals' feelings of hopelessness. In this case, it evaluates three aspects of hopelessness: 1. A person's expectations about life; 2. Their feelings about the future, and 3. The loss of motivation. Pre-intervention and inmediately after the intervention
Secondary Perceived level of feasibility by professionals Feasibility is measured with the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017), a measure that encompasses four items designed to measure the feasibility of the intervention, indicating the extent to which the intervention can be successfully executed within the system, using a 5-point Likert scale. Pre-intervention and inmediately after the intervention
Secondary Perceived level of acceptability of the intervention by professionals The Acceptability of Intervention Measure (AIM) (Weiner et al., 2017) assesses acceptability based on stakeholders' perceptions of the intervention's utility or satisfaction across four items on a 5-point Likert scale. Pre-intervention and inmediately after the intervention
Secondary Satisfaction of the intervention by patients The Client Satisfaction Questionnaire (CSQ) (Attkisson & Zwick, 1982; Larsen et al., 1979) is an eight-item questionnaire that assesses participants' overall satisfaction with the intervention received on a 4-point scale. Pre-intervention and inmediately after the intervention
Secondary Perceived level of adequacy by professionals Intervention Appropriateness Measurement (IAM) (Weiner et al., 2017) comprises four 5-point Likert scale items designed to explore the adequacy of the intervention, considering its perceived relevance or compatibility in the given context. Pre-intervention and inmediately after the intervention
Secondary Barriers and facilitators detected by professionals that are influencing the implementation process - Quantitative information Quantitative data about barriers and facilitators is gathered thrhough closed-open questionnaire was developed following CFIR guidelines (Damschroder et al., 2009), with reference to the study conducted by Hadjistavropoulos and colleagues (2017). The final questionnaire comprised 41 items rated on a 5-point Likert scale (ranging from 1, strongly disagree, to 5, strongly agree), assessing: Intervention Characteristics (7 items), Outer Context (5 items), Inner Setting (14 items), Characteristics of Individuals (8 items), and Implementation Process (7 items). Pre-intervention and inmediately after the intervention
Secondary Level of burnout of professionals Using the Copenhagen Burnout Inventory (CBI) (Kristensen et al., 2005), a 19-item questionnaire on a 5-point Likert scale that measures burnout syndrome, differentiating three sub-dimensions: personal burnout, work-related burnout, and user-related burnout. Pre-intervention and inmediately after the intervention
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06311591 - Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part B N/A
Recruiting NCT05602779 - Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents N/A
Completed NCT03768674 - Extreme Challenges - Psychopathology & Treatment Experiences Among Severly Selfharming Inpatients in Norway
Completed NCT04244786 - Treating Self Injurious Behavior: A Novel Brain Stimulation Approach N/A
Recruiting NCT05282225 - Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care N/A
Completed NCT04131179 - Multicenter Study to Evaluate the Clinical and Cost Effectiveness of a Youth Culturally Adapted Therapy (YCMAP) N/A
Completed NCT03709472 - Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth N/A
Enrolling by invitation NCT03309527 - E-aid Sleep-focused TrEatment for Prevention of Major Depression (STEP-MD) N/A
Not yet recruiting NCT00884078 - Self Harm in Females of South Asian Family Origin N/A
Completed NCT03838198 - An Adaptive Intervention for Adolescents at Risk for Suicide: A Pilot SMART N/A
Not yet recruiting NCT05363969 - Treatment of Self Harm Scars With Fraxel Laser N/A
Completed NCT03541824 - Reducing Suicide Risk Associated With Weight Loss N/A
Completed NCT05206734 - Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
Recruiting NCT03846375 - Emotional Dysregulation in Para-suicidal Behavior N/A
Recruiting NCT06025942 - Purrble With LGBTQ+ Youth Who Have Self-harmful Thoughts N/A
Active, not recruiting NCT06353100 - Chronic Pain in the General Population of Chile
Recruiting NCT04318899 - Predictors of Clinical Course and Treatment Response in DBT Programmes N/A
Recruiting NCT06223867 - Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part A N/A
Active, not recruiting NCT05767840 - Integrated Mental Healthcare Plan for Management of Depression and Self-harm in Pakistan N/A
Not yet recruiting NCT06317155 - Occupational Therapy for Children and Young People Who Self-harm: A Qualitative Study