Complex post-traumatic stress disorder (CPTSD) Mental and Behavioural Disorders
Conditions
Interventions
This is a feasibility trial of Seeking Safety. The objective is to test processes and gather information for the planning of a definitive randomised controlled trial (RCT) to evaluate Seeking Safety f
Sponsors
South West Yorkshire Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Diagnosed with CPTSD or assessed as meeting the ICD-11 criteria 3. Receiving care from a CMHT or on a waiting list for psychological therapy in South West Yorkshire Partnership NHS Foundation Trust 4. Able to provide informed consent 5. Willing and able to attend a Seeking Safety group
Exclusion criteria
Exclusion criteria: 1. People with recurrent episodes of psychosis 2. People with a severe cognitive impairment 3. People currently receiving another psychological therapy for CPTSD or inpatient care 4. People assessed as posing a risk to other people in a group setting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of eligible people who consent to participate measured using Screening Log, study specific records and consent records at Screening/Pre-consent & Consent;Proportion of consented participants who complete baseline data and are randomised measured using Research data, screening log and randomisation records at Baseline & Randomisation;Proportion of participants completing end-of-treatment and follow-up assessments measured using Research data and withdrawal records at End of Treatment (6 months post randomisation), 12 months follow up;Proportion of participants completing the intervention (defined as attending at least 6 sessions) measured using Attendance records at Intervention period;Acceptability and feasibility of completing outcome measures measured using Qualitative interviews and research data at Interview period between End of Treatment (6 months post randomisation) and 12 Months follow up;Participants’ experience of Seeking Safety measured using Qualitative interviews at Interview period between End of Treatment (6 months post randomisation) and 12 Months follow up;Healthcare staff experience of delivering Seeking Safety measured using Qualitative interviews at Interview period between End of Treatment (6 months post randomisation) and 12 Months follow up;Control group tolerance of waiting for Seeking Safety measured using Qualitative interviews at Interview period between End of Treatment (6 months post randomisation) and 12 Months follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PTSD symptoms measured using Impact of Events Scale – Revised (IES-R), a 22-item self-report measure of subjective distress caused by traumatic events, at baseline, end of treatment (6 months post randomisation) and 12 months follow up 2. Substance use measured using Leeds Dependence Questionnaire (LDQ), a 10-item self-report measure designed to assess dependence on a variety of substances, at baseline, end of treatment (6 months post randomisation) and 12 months follow up 3. Mental wellbeing measured using Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), a widely used 14-item scale for assessing mental wellbeing in the general population, at baseline, end of treatment (6 months post randomisation) and 12 months follow up 4. Social functioning measured using Work and Social Adjustment Scale (WSAS), a 5-item measure assessing the impact of mental health on day-to-day functioning, at baseline, end of treatment (6 months post randomisation) and 12 months follow up 5. Health-related quality of life measured using EQ-5D-5L, a 5-domain tool with an additional self-rated health assessment, at baseline, end of treatment (6 months post randomisation) and 12 months follow up 6. Capability wellbeing measured using ICEpop CAPability Instrument for Adults (ICECAP-A), a 5-item tool assessing wellbeing and quality of life, at baseline, end of treatment (6 months post randomisation) and 12 months follow up 7. Service use measured using a modified version of the Client Services Receipt Inventory (CSRI), adapted for this study to assess service use, at baseline, end of treatment (6 months post randomisation) and 12 months follow up 8. Life events measured using the List of Threatening Experiences (LTE-Q), a 12-item tool assessing the impact of significant life events, at end of treatment (6 months post randomisation) and 12 months follow up | — |
Countries
England, United Kingdom
Contacts
Public ContactKasia Malczuk
Outcome results
None listed