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Self HarmNCT06297460

Adaptation of STEPPS Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers

A study testing Systems Training for Emotional Predictability & Problem Solving (STEPPS) in people with Self Harm, run by Universitat Jaume I at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Self Harm
What is being tested?
Systems Training for Emotional Predictability & Problem Solving (STEPPS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
1 Jan 2022to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Rosa

    Castellon, Castellón, 12071

Other trials in Spain

About this study

Official title: Adaptation of the Systems Training for Emotional Predictability & Problem Solving (STEPPS) Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers in Catalonia

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.

Conditions
Self Harm
Being tested
Systems Training for Emotional Predictability & Problem Solving (STEPPS)
Medical subject headings
Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Systems Training for Emotional Predictability & Problem Solving (STEPPS)Behavioural

    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).

Study groups in NCT06297460
Study groupRoleWhat they receive
STEPPS programExperimentalThe only condition is the experimental one. Participants receive the STEPPS program
Receives: Behavioral: Systems Training for Emotional Predictability & Problem Solving (STEPPS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Pre-intervention and inmediately after the intervention

Secondary outcomes (10)

  1. 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.

    Measured: Pre-intervention and inmediately after the intervention

  2. 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).

    Measured: Pre-intervention and inmediately after the intervention

  3. 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.

    Measured: Pre-intervention and inmediately after the intervention

  4. 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.

    Measured: Pre-intervention and inmediately after the intervention

  5. 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.

    Measured: Pre-intervention and inmediately after the intervention

  6. 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.

    Measured: Pre-intervention and inmediately after the intervention

  7. 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.

    Measured: Pre-intervention and inmediately after the intervention

  8. 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.

    Measured: Pre-intervention and inmediately after the intervention

  9. 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).

    Measured: Pre-intervention and inmediately after the intervention

  10. 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.

    Measured: Pre-intervention and inmediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study start1 Jan 2022
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06297460
Sponsor's protocol ID
STEPPSPENITENTIARY
Status last verified
Mar 2024
First submitted
8 Jan 2024
Last updated
7 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18955943

  • 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.

    PubMed 23364121

  • 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.

    PubMed 31343744

  • 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.

    PubMed 35211734

  • Lorente-Catala R, Garcia-Palacios A. Hybrid effectiveness-implementation studies in mental health: three practical examples. JBI Evid Implement. 2026 Jul 1;24(3):652-668. doi: 10.1097/XEB.0000000000000592.

    PubMed 42112661

  • 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.

    PubMed 39885488

  • 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.

    PubMed 39819704

Questions about this trial

What is this clinical trial studying?

A study testing Systems Training for Emotional Predictability & Problem Solving (STEPPS) in people with Self Harm, run by Universitat Jaume I at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of emotional and behavioral disregulation of patients (time frame: Pre-intervention and inmediately after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06297460, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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