Personality DisorderSTEPPS-HINCT02601391
An Evaluation of an Adapted STEPPS Group Within Forensic Services
A study testing Adapting STEPPS within forensic inpatient services. in people with Personality Disorder, run by Sussex Partnership NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Personality Disorder
- What is being tested?
- Adapting STEPPS within forensic inpatient services.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2021to 6 Jan 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Elizabeth Collins
Hellingly, East Sussex, BN20 4ER
About this study
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
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.
Read the 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.
- Conditions
- Personality Disorder
- Being tested
- Adapting STEPPS within forensic inpatient services.
- Keywords
- STEPPS-HI, personality disorder, evaluation, forensic
- Medical subject headings
- Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapting STEPPS within forensic inpatient services.Behavioural
Also called STEPPS-HI
This study will focus upon delivering the STEPPs-HI group within Forensic Healthcare Inpatient Services.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Adapting STEPPS within forensic inpatient services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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).
Modified Overt Aggression Scale (MOAS: Yudofsky, J. M. Silver, W. Jackson, J. Endicott, \& D. W. Williams, 1986).
Measured: 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).
Circumplex of Interpersonal Relationships in Closed Living Environments
Measured: Assess at baseline (start of group) and reassess end of group (26 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study start6 Jan 2021
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Why it stopped: Not able to run research in the service. Research terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sussex Partnership NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liz Collins, Sussex Partnership NHS Foundation Trust
- Investigators
- Elizabeth R Collins, Principal investigator, Sussex Partnership NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601391
- Sponsor's protocol ID
- SPFT-1
- Acronym
- STEPPS-HI
- Status last verified
- Jan 2021
- First submitted
- 26 Oct 2015
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 23364121Blackburn, R., & Renwick, S. J. (1996). Rating scales for measuring the interpersonal circle in forensic psychiatric patients. Psychological Assessment, 8, 76-84
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.
Braun, V. & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77 - 101.
Connell, J. & Barkham, M. (2007). Core-10 User Manual, Version 1.1. Core System Trust & Core Information Management Systems Ltd.
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.
PubMed 18414278Gratz, 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.
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.
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.
Sarkar, J., & di Lustro, M. (2011). Evolution of secure services for women in England. Advances in Psychiatric Treatment, 17, 323-331.
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.
PubMed 3942284Zanarini 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.
PubMed 12839102
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02601391
- Acronym / sponsor ID
- STEPPS-HI / SPFT-1
- Conditions
- Personality Disorder
- Keywords
- STEPPS-HI, personality disorder, evaluation, forensic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to run research in the service. Research terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sussex Partnership NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEPPS within forensic services. | Other | Behavioral: Adapting STEPPS within forensic inpatient services.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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapting STEPPS within forensic inpatient services.Also: STEPPS-HIThis study will focus upon delivering the STEPPs-HI group within Forensic Healthcare Inpatient Services. | Behavioural | STEPPS within forensic services. |
Primary outcome
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)
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).
Time frame: 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
2 secondary outcomes
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)
Circumplex of Interpersonal Relationships in Closed Living Environments (CIRCLE; Blackburn & Renwick, 1996).
Time frame: Assess at baseline (start of group) and reassess end of group (26 weeks later)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Background: PubMed 23364121Black 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.
- BackgroundBlackburn, R., & Renwick, S. J. (1996). Rating scales for measuring the interpersonal circle in forensic psychiatric patients. Psychological Assessment, 8, 76-84
- BackgroundBlum, 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.
- BackgroundBraun, V. & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77 - 101.
- BackgroundConnell, J. & Barkham, M. (2007). Core-10 User Manual, Version 1.1. Core System Trust & Core Information Management Systems Ltd.
- Background: PubMed 18414278Dickinson 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.
- BackgroundGratz, 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.
- BackgroundHarvey 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.
- BackgroundPipon-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.
- BackgroundSarkar, J., & di Lustro, M. (2011). Evolution of secure services for women in England. Advances in Psychiatric Treatment, 17, 323-331.
- Background: PubMed 3942284Yudofsky 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.
- Background: PubMed 12839102Zanarini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth R Collins principal investigator
Sussex Partnership NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapting STEPPS within forensic inpatient services. in people with Personality Disorder, run by Sussex Partnership NHS Foundation Trust at 1 site in United Kingdom.
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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 7 Jan 2021. 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 United Kingdom. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
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)). The study lists 2 primary outcomes in all. 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 NCT02601391, which also lists 12 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 Jan 2021.