Clinical trial NCT02601391: An Evaluation of an Adapted STEPPS Group Within Forensic Services
Official title: Adapting the Systems Training and Emotional Predictability and Problem Solving Group (STEPPS) for Service Users With Complex Needs. A Pilot Evaluation of STEPPS High Intensity (STEPPS HI) Within Forensic Inpatient Services
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Personality Disorder
Keywords: STEPPS-HI
personality disorder
evaluation
forensic
Lead sponsor: Sussex Partnership NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Systems Training for Emotional Predictability and Problem Solving (STEPPS) is a manualised group programme for people primarily with a diagnosis of Borderline Personality Disorder (BPD). Although, STEPPS groups have been run within prisons in USA, it has been less formally evaluated within forensic psychiatric settings except for Pipon-Young \& Cole (2012). Taking the learning from these studies into account, significant adaptations to the current STEPPS manual are needed to increase the acceptability and applicability of the group within forensic settings.

Following the adaption of the STEPPS manual for a forensic inpatient population (STEPPS HI), this research aims to investigate how effective the group is at improving emotional regulation skills in those with identified difficulties in the area as well as whether there is increased acceptability of the adapted group for the participants. The outcome of the research is intended to provide feedback on the adaption of the STEPPS manual and also an evaluation of the revised programme.

Eligibility criteria: Inclusion Criteria:

* 18 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To assess change from baseline (start of group) on the Symptom Checklist-Revised (SCL-90-R), reassessing at end of group (26 weeks later).
timeFrame: Assess at baseline (start of group) and reassess end of group (26 weeks later)
measure: 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).
timeFrame: Assess at baseline (start of group) and reassess end of group (26 weeks later)
Secondary outcomes:
measure: Modified Overt Aggression Scale (MOAS: Yudofsky, J. M. Silver, W. Jackson, J. Endicott, & D. W. Williams, 1986).
timeFrame: Assess at baseline (start of group) and reassess end of group (26 weeks later)
measure: Circumplex of Interpersonal Relationships in Closed Living Environments (CIRCLE; Blackburn & Renwick, 1996).
timeFrame: Assess at baseline (start of group) and reassess end of group (26 weeks later)
Other outcomes:
measure: Number of self-harm incidents as assessed by Sussex Partnership NHS Foundation Trust Incident Reporting System.
timeFrame: 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).
measure: Number of violent incidents as assessed by Sussex Partnership NHS Foundation Trust Incident Reporting System.
timeFrame: 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).
measure: 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).
timeFrame: This will be completed at the end of the group intervention (26 weeks) with service users being invited to attend a semi-structured interview.
measure: Assessing research participants (group facilitators) views of the adapted group manual via attendance at a focus group, utilising thematic analysis to analyse the data gathered (Braun & Clarke, 2006).
timeFrame: This will be completed at the end of the group intervention (26 weeks) with group facilitators being invited to attend a focus group.
measure: Record of research participants (service users) observational levels as assessed by Sussex Partnership NHS Foundation Trust general, intermittent and within eyesight recording forms.
timeFrame: A record of observational level forms (general, intermittent and within eyesight) will be collected weekly from one month prior to group starting, weekly through group intervention (26 weeks) and then weekly for one month after the group has finished (at
measure: Record of leave status for each research participants (service user) as assessed by Sussex Partnership NHS Foundation Trust Mental Health Act 1983 - Section 17 Leave of Absence Forms.
timeFrame: A record of leave status will be collected weekly from one month prior to group starting, weekly through group intervention (26 weeks) and then weekly for one month after the group has finished (at 30 weeks).
Locations:
city: Hellingly
country: United Kingdom
facility: Elizabeth Collins
state: East Sussex
Study officials:
affiliation: Sussex Partnership NHS Foundation Trust
name: Elizabeth R Collins
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Blackburn, R., & Renwick, S. J. (1996). Rating scales for measuring the interpersonal circle in forensic psychiatric patients. Psychological Assessment, 8, 76-84
citation: 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.
citation: Braun, V. & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77 - 101.
citation: Connell, J. & Barkham, M. (2007). Core-10 User Manual, Version 1.1. Core System Trust & Core Information Management Systems Ltd.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Sarkar, J., & di Lustro, M. (2011). Evolution of secure services for women in England. Advances in Psychiatric Treatment, 17, 323-331.
citation: 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.
citation: 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.