Assessing psychological support for people with emotional distress and difficulties in relationships: The SPS study

Not Applicable

Conditions: Personality disorder
Mental and Behavioural Disorders

Registration Number: ISRCTN13918289

Lead Sponsor: Imperial College London

Brief Summary: 2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38925701/ (added 28/06/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 308

Inclusion Criteria

Current inclusion criteria as of 31/08/2023:
1. Probable personality disorder on the Standardised Assessment of Personality Abbreviated Scale (score of 4 or more)
2. Age 18 years old and over
3. Being treated by mental health staff working in a primary or secondary care NHS setting

Process evaluation:
4. Involved in the trial in any way or have indicated an interest in talking about their reasons for declining as part of the process evaluation if they declined when initially approached

Previous inclusion criteria:
Trial involvement:
1. Age 18 years old and over
2. Being treated by mental health staff working in a primary or secondary care NHS setting

Process evaluation:
3. Involved in the trial in any way or have indicated an interest in talking about their reasons for declining as part of the process evaluation if they declined when initially approached

Exclusion Criteria

Current exclusion criteria as of 31/08/2023:
1. Unable or unwilling to provide written informed consent
2. Co-existing organic or psychotic mental disorder
3. In receipt of psychological treatment for personality disorder or are on a waiting list of <1 year for such treatment
5. Anyone currently a participant in a clinical trial or other interventional research will not be eligible to take part until their participation is complete

Previous exclusion criteria:
1. Probable personality disorder on the Standardised Assessment of Personality Abbreviated Scale
2. Unable or unwilling to provide written informed consent
3. Co-existing organic or psychotic mental disorder
4. In receipt of psychological treatment for personality disorder or are on a waiting list for such treatment
5. Anyone currently a participant in a clinical trial or other interventional research will not be eligible to take part until their participation is complete.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Social functioning measured using the Work and Social Adjustment Scale total score at 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
1. Mental health measured using the 16-item Difficulties in Emotion Regulation Scale, the nine-item Patient Health Questionnaire, and the seven-item Generalised Anxiety Disorder scale at 6 and 12 months<br>2. Suicidal thoughts and behaviour measured using items from the National Household Survey of Psychiatric Morbidity scale at 6 and 12 months<br>3. Health-related quality of life measured using the EQ-5D-5L at 6 and 12 months<br>4. Patient experience measured using the patient-rated Global Improvement scale and the patient-rated Satisfaction with Care scale at 6 and 12 months<br>5. Personality status measured using the Standardised Assessment of Personality – Abbreviated Scale at 6 and 12 months