NCT06297460

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

January 8, 2024

Last Update Submit

March 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Type and levels of impulsivity of patients

    Pre-intervention and inmediately after the intervention

  • Suicide risk of patients

    Pre-intervention and inmediately after the intervention

  • Self-injury frequency, typology and funcionality of patients

    Pre-intervention and inmediately after the intervention

  • Degree of hopeless of patients

    Pre-intervention and inmediately after the intervention

  • Perceived level of feasibility by professionals

    Pre-intervention and inmediately after the intervention

  • +5 more secondary outcomes

Other Outcomes (1)

  • Barriers and facilitators detected by professionals that are influencing the implementation process - Qualitative information

    Inmediately after the intervention

Study Arms (1)

STEPPS program

EXPERIMENTAL

The only condition is the experimental one. Participants receive the STEPPS program

Behavioral: Systems Training for Emotional Predictability & Problem Solving (STEPPS)

Interventions

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).

STEPPS program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rosa

Castellon, Castellón, 12071, Spain

Location

Related Publications (6)

  • 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.

    PMID: 18955943BACKGROUND
  • 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.

    PMID: 23364121BACKGROUND
  • 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.

    PMID: 31343744BACKGROUND
  • 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.

    PMID: 35211734BACKGROUND
  • Lorente-Catala R, Jaen I, Busca-Huertas X, Framis B, Garcia-Palacios A. Implementation of the STEPPS program for the treatment of self-harm behaviors in Catalonia's prisons: barriers and facilitators. BMC Public Health. 2025 Jan 30;25(1):378. doi: 10.1186/s12889-025-21519-8.

  • Lorente-Catala R, Jaen I, Busca-Huertas X, Framis B, Garcia-Palacios A. Treating self-harm behaviors in prisons: implementation of the STEPPS program. BMC Psychol. 2025 Jan 16;13(1):43. doi: 10.1186/s40359-024-02342-z.

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Technical Staff

Study Record Dates

First Submitted

January 8, 2024

First Posted

March 7, 2024

Study Start

January 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations