NCT02601391

Brief Summary

The purpose of this study is to determine how effective the STEPPS-HI group is at improving emotional regulation skills in those with identified difficulties in this area within forensic inpatient services. In addition, to explore whether there is increased acceptability of the adapted STEPPS group (STEPPS-HI) for this client group.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
5.2 years until next milestone

Study Start

First participant enrolled

January 6, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2021

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

October 26, 2015

Last Update Submit

January 6, 2021

Conditions

Keywords

STEPPS-HIpersonality disorderevaluationforensic

Outcome Measures

Primary Outcomes (2)

  • To assess change from baseline (start of group) on the Symptom Checklist-Revised (SCL-90-R), reassessing at end of group (26 weeks later).

    To assess change from baseline (start of group) on the Symptom Checklist-Revised (SCL-90-R), reassessing at end of group (26 weeks later).

    Assess at baseline (start of group) and reassess end of group (26 weeks later)

  • To assess change from baseline (start of group) on the Zanarini Rating Scale for Borderline Personality Disorder, reassessing at end of group (26 weeks later).

    To assess change from baseline (start of group) on the Zanarini Rating Scale

    Assess at baseline (start of group) and reassess end of group (26 weeks later)

Secondary Outcomes (2)

  • Modified Overt Aggression Scale (MOAS: Yudofsky, J. M. Silver, W. Jackson, J. Endicott, & D. W. Williams, 1986).

    Assess at baseline (start of group) and reassess end of group (26 weeks later)

  • Circumplex of Interpersonal Relationships in Closed Living Environments (CIRCLE; Blackburn & Renwick, 1996).

    Assess at baseline (start of group) and reassess end of group (26 weeks later)

Other Outcomes (6)

  • Number of self-harm incidents as assessed by Sussex Partnership NHS Foundation Trust Incident Reporting System.

    A record of self-harm incidents will be collected weekly from one month prior to the group starting, weekly through the group intervention (26 weeks) and then weekly for one month after the group has finished (at 30 weeks).

  • Number of violent incidents as assessed by Sussex Partnership NHS Foundation Trust Incident Reporting System.

    A record of violent incidents will be collected weekly from one month prior to the group starting, weekly through the group intervention (26 weeks) and then weekly for one month after the group has finished (at 30 weeks).

  • Assessing research participants (service users) views regarding group content, via attendance at a semi-structured interview utilising thematic analysis to analyse the data gathered (Braun & Clarke, 2006).

    This will be completed at the end of the group intervention (26 weeks) with service users being invited to attend a semi-structured interview.

  • +3 more other outcomes

Study Arms (1)

STEPPS within forensic services.

OTHER

Forensic inpatients attend the STEPPS-HI group. Consent will be obtained. Pre and post group psychometric questionnaires will be completed as well as each service user attending a short semi-structured interview following the conclusion of the group . Primary nurse will fill in pre and post group questionnaires. Facilitators will complete short feedback forms each session and attend a focus group upon completion. Psychology Assistants/Interns will collect records of self harm and violence/aggressive incidents for each service user as well as records of nursing observation level and leave status taken.

Behavioral: Adapting STEPPS within forensic inpatient services.

Interventions

This study will focus upon delivering the STEPPs-HI group within Forensic Healthcare Inpatient Services.

Also known as: STEPPS-HI
STEPPS within forensic services.

Eligibility Criteria

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

You may qualify if:

  • years or older.
  • To give informed consent to participate in the study.
  • Currently a resident in a low or medium secure unit.
  • Has been diagnosed as meeting DSM-IV criteria for a personality disorder at some stage in their mental health history.
  • Has identified difficulties with emotional regulation.
  • Be willing and have suitable abilities to participate in a group.
  • To be assessed by the clinical team as sufficiently psychologically robust to participate in the group and the research.

You may not qualify if:

  • Psychiatric/psychological or any other difficulties that would mean that participants could not give informed consent.
  • Intellectual/cognitive impairment which prohibits participants ability to consent or fully comprehend the study or study materials.
  • Non-English speakers as there is no provision for interpreters.
  • Unable to manage a group environment due to risk to self and others including bullying and violence (this will be assessed by the clinical and STEPPS-HI facilitation team.
  • No evidence of emotional regulation difficulties.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elizabeth Collins

Hellingly, East Sussex, BN20 4ER, United Kingdom

Location

Related Publications (12)

  • 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
  • Blackburn, R., & Renwick, S. J. (1996). Rating scales for measuring the interpersonal circle in forensic psychiatric patients. Psychological Assessment, 8, 76-84

    BACKGROUND
  • Blum, N., Bartels N., St. John, D., Pfohl, B. (2002). STEPPS: Systems Training for Emotional Predictability and Problem Solving: Group Treatment for Borderline Personality Disorder. Coralville, Iowa, Blum's Books.

    BACKGROUND
  • Braun, V. & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77 - 101.

    BACKGROUND
  • Connell, J. & Barkham, M. (2007). Core-10 User Manual, Version 1.1. Core System Trust & Core Information Management Systems Ltd.

    BACKGROUND
  • Dickinson T, Wright KM. Stress and burnout in forensic mental health nursing: a literature review. Br J Nurs. 2008 Jan 24-Feb 13;17(2):82-7. doi: 10.12968/bjon.2008.17.2.28133.

    PMID: 18414278BACKGROUND
  • Gratz, K. L. & Roemer, E. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26, 41-54.

    BACKGROUND
  • Harvey R, Black DW, Blum N (2010) STEPPS (Systems Training for Emotional Predictability and Problem Solving) in the United Kingdom: A preliminary report. Journal of Contemporary Psychotherapy. 40, 225-232.

    BACKGROUND
  • Pipon-Young, L., & Cole, S. (2012). A preliminary evaluation of the Systems Training for Emotional Predictability and Problem Solving (STEPPS) group in a women's forensic medium secure unit. Clinical Psychology Forum, 239, 35 - 39.

    BACKGROUND
  • Sarkar, J., & di Lustro, M. (2011). Evolution of secure services for women in England. Advances in Psychiatric Treatment, 17, 323-331.

    BACKGROUND
  • Yudofsky SC, Silver JM, Jackson W, Endicott J, Williams D. The Overt Aggression Scale for the objective rating of verbal and physical aggression. Am J Psychiatry. 1986 Jan;143(1):35-9. doi: 10.1176/ajp.143.1.35.

    PMID: 3942284BACKGROUND
  • Zanarini MC, Vujanovic AA, Parachini EA, Boulanger JL, Frankenburg FR, Hennen J. Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD): a continuous measure of DSM-IV borderline psychopathology. J Pers Disord. 2003 Jun;17(3):233-42. doi: 10.1521/pedi.17.3.233.22147.

    PMID: 12839102BACKGROUND

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Elizabeth R Collins

    Sussex Partnership NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
0

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
Trainee Forensic Psychologist

Study Record Dates

First Submitted

October 26, 2015

First Posted

November 10, 2015

Study Start

January 6, 2021

Primary Completion

January 6, 2021

Study Completion

January 6, 2021

Last Updated

January 7, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations