Complex Post-Traumatic Stress Disorder (CPTSD) Mental and Behavioural Disorders Post-traumatic stress disorder
Conditions
Interventions
Approximately even numbers are allocated to the two treatment arms, phased CT-PTSD and non-phased CT-PTSD
allocation is stratified based on site, CPTSD symptom severity, age at main trauma (<18 years vs 18 years and above) and need for a translator (yes vs no)
the randomization sequence is not visible to the research staff who generate the treatment randomization with the programme to ensure allocation concealment.
CT-PTSD is a NICE-recommended first-line
Sponsors
Queen's University Belfast
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and above 2. Willing and able to provide informed consent 3. Meets ICD-11 diagnostic criteria for CPTSD as determined by the International Trauma Interview (ITI) 4. CPTSD is the main psychological problem needing treatment 5. Willing to be randomized to a treatment arm 6. If taking psychotropic medication, the dose must be stable for at least 1 month before randomization to a treatment arm 7. If currently receiving psychological therapy for CPTSD, this treatment must have ended before being randomized to a treatment arm
Exclusion criteria
Exclusion criteria: 1. History of psychosis 2. Current substance dependence 3. Acute serious suicide risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Complex PTSD symptom severity, as assessed by the International Trauma Questionnaire (ITQ) at 26 weeks post-randomisation. 2. PTSD symptom severity also measured by: 1.1. ITQ at 9, 17, 39 and 52 weeks 1.2. International Trauma Interview (ITI) at 26 and 52 weeks 1.3. Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) at 9, 17, 39 and 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1: Depression measured using the Patient Health Questionnaire (PHQ-9) at weeks 9, 17, 26, 39 and 52 2. Anxiety measured using the Generalized Anxiety Disorder 7-item (GAD-7) at weeks 9, 17, 26, 39 and 52 3. Disability measured using the Work and Social Adjustment Scale (WSAS) at weeks 9, 17, 26, 39 and 52 4: Well-being measured using the WHO (Five) Well-Being Index at weeks 9, 17, 26, 39 and 52 5. Quality of Life measured using the Endicott Quality of Life (QoL) Scale at 9, 26, 39 and 52 weeks 6. Credibility and outcome expectancy measured using the Borkovec and Nau’s Credibility/Expectancy (CES) Scale at 2 and 10 weeks 7. Attendance and adherence to interventions measured using therapist report at week 26 8. Drop-outs from treatment and reasons measured using [method/data source] treatment log and CTU database at 26 weeks 9. Patient experience of therapy measured using the IAPT Patient Experience Questionnaire (PEQ) at 26 weeks | — |
Countries
England, Northern Ireland, United Kingdom
Contacts
Public ContactNina O'Neill
Outcome results
None listed