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An Evaluation of an Adapted STEPPS Group Within Forensic Services (STEPPS-HI)

Primary Purpose

Personality Disorder

Status

Withdrawn

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Adapting STEPPS within forensic inpatient services.

About this trial

This is an interventional treatment trial for Personality Disorder focused on measuring STEPPS-HI, personality disorder, evaluation, forensic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Elizabeth Collins

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

STEPPS within forensic services.

Arm Description

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.

Outcomes

Primary Outcome Measures

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 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

Secondary Outcome Measures

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

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

Circumplex of Interpersonal Relationships in Closed Living Environments

Full Information

NCT ID

NCT02601391

First Posted

October 26, 2015

Last Updated

January 6, 2021

Sponsor

Sussex Partnership NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT02601391

Brief Title

An Evaluation of an Adapted STEPPS Group Within Forensic Services

Acronym

STEPPS-HI

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Not able to run research in the service. Research terminated.

Study Start Date

January 6, 2021 (Actual)

Primary Completion Date

January 6, 2021 (Actual)

Study Completion Date

January 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sussex Partnership NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Personality Disorder

Keywords

STEPPS-HI, personality disorder, evaluation, forensic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

STEPPS within forensic services.

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Adapting STEPPS within forensic inpatient services.

Other Intervention Name(s)

STEPPS-HI

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

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).

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

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

Description

Circumplex of Interpersonal Relationships in Closed Living Environments

Time Frame

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

Other Pre-specified Outcome Measures:

Title

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

Description

Data will be reviewed via assessing the Sussex Partnership NHS Foundation Trust Incident Reporting System. Key information will be extracted i.e. number of self-harm incidents within the time frames stated in the time frame section. An excel spread sheet to collect this information will be developed by the study's principal investigator and the data will be inputted into the spread sheet by the Psychology Interns. Data analysis (a paired-samples t-test) will be conducted to compare the mean rates of self-harm incidents pre-group and post group.

Time Frame

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).

Title

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

Description

Data will be reviewed via assessing the Sussex Partnership NHS Foundation Trust Incident Reporting System. Key information will be extracted i.e. number of violent incidents within the time frames stated in the time frame section. An excel spread sheet to collect this information will be developed by the study's principal investigator and the data will be inputted into the spread sheet by the Psychology Interns. Data analysis (a paired-samples t-test) will be conducted to compare the mean rates of violent incidents pre-group and post group.

Time Frame

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).

Title

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).

Description

Research participants will be invited to attend a 1-1 semi-structured interview to capture their views on group content, format, structure, process, non-attendance and drop-put rates. The qualitative data gathered will be analysed by the principal investigator using thematic analysis (Braun & Clarke, 2006).

Time Frame

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

Title

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).

Description

Research participants will be invited to attend a focus group to capture overall views on the adapted manual. The qualitative data gathered will be analysed by the principal investigator using thematic analysis (Braun & Clarke, 2006).

Time Frame

This will be completed at the end of the group intervention (26 weeks) with group facilitators being invited to attend a focus group.

Title

Record of research participants (service users) observational levels as assessed by Sussex Partnership NHS Foundation Trust general, intermittent and within eyesight recording forms.

Description

Data will be reviewed via assessing the Sussex Partnership NHS Foundation Trust record of observational level forms (general, intermittent and within eyesight). Key information will be extracted i.e. changes within observational levels in the time frames stated in the time frame section. An excel spread sheet to collect this information will be developed by the study's principal investigator and the data will be inputted into the spread sheet by the Psychology Interns. The data gathered will be reported in the demographic section of the result within the journal article developed to disseminate the outcomes of the study.

Time Frame

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

Title

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.

Description

Data will be reviewed via assessing Sussex Partnership NHS Foundation Trust Mental Health Act 1983 - Section 17 Leave of Absence Forms for each research participant. Key information will be extracted i.e. changes within level status in the time frames stated in the time frame section. An excel spread sheet to collect this information will be developed by the study's principal investigator and the data will be inputted into the spread sheet by the Psychology Interns. The data gathered will be reported in the demographic section of the result within the journal article developed to disseminate the outcomes of the study.

Time Frame

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth R Collins

Organizational Affiliation

Sussex Partnership NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Elizabeth Collins

City

Hellingly

State/Province

East Sussex

ZIP/Postal Code

BN20 4ER

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23364121

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.

Results Reference

background

Citation

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

Results Reference

background

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.

Results Reference

background

Citation

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

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

18414278

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.

Results Reference

background

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.

Results Reference

background

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.

Results Reference

background

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

3942284

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.

Results Reference

background

PubMed Identifier

12839102

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. Erratum In: J Personal Disord. 2003 Aug;17(4):1 p following 369.

Results Reference

background

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An Evaluation of an Adapted STEPPS Group Within Forensic Services

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