WithdrawnNot Applicable

An Evaluation of an Adapted STEPPS Group Within Forensic Services

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

United Kingdom0Started 2021-01-06

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

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)

Trial details

NCT IDNCT02601391

SponsorSussex Partnership NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-06

View on ClinicalTrials.gov More Personality Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

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)