Posttraumatic stress disorder Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients: 1. Post-Traumatic Stress Disorder is the main psychological problem, and the patient's priority to work on in therapy 2. Any gender, aged 18 years or above with no upper age limit 3. Access to an internet-enabled device at home or another safe location with a reliable internet connection; access to a mobile phone that can receive text messages 4. Able to speak, read and write English 5. Willingness to be allocated by chance to either iCT-PTSD or NHS TT non-digital psychological treatment as usual (TAU) Clinicians: 1. High intensity CBT therapist working within a participating NHS TT service 2. Trained in the delivery of iCT-PTSD 3. Willing to participate 4. Clinical capacity and managerial approval to participate
Exclusion criteria
Exclusion criteria: Patients: 1. PTSD Checklist 5 (PCL-5) score below clinical caseness (< 32) 2. Acute suicide risk 3. Substance dependence Clinicians: 1. No exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.PTSD symptoms measured with the PCL Symptom Checklist for DSM-5 (PCL-5) completed at baseline, 22 weeks, 44 weeks and 66 weeks post-randomisation, and actual end of treatment if different from 22 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.. Reliable improvement and reliable recovery as defined in NHS TT manual based on by cut-offs on the PTSD Symptom Checklist for DSM-5 (PCL-5) and Patient Health Questionnaire (PHQ-9) at 22 weeks after randomisation, and actual end of treatment if different from 22 weeks. 2. Complex PTSD symptoms measured with the International Trauma Questionnaire (ITQ) at baseline, 22 weeks, 44 weeks and 66 weeks, and actual end of treatment if different from 22 weeks. 3. Depression symptoms measured with the Patient Health Questionnaire (PHQ-9) completed at baseline, 22 weeks, 44 weeks and 66 weeks, and actual end of treatment if different from 22 weeks, and actual end of treatment if different from 22 weeks. 4. Anxiety symptoms measured with the Generalised Anxiety Disorder Questionnaire (GAD-7) completed at baseline, 22 weeks, 44 weeks, 66 weeks and actual end of treatment if different from 22 weeks. 5. Interference with life due to mental health difficulties as measured with the Work and Social Adjustment Scale (WSAS) completed at baseline, 22 weeks, 44 weeks and 66 weeks, and actual end of treatment if different from 22 weeks.. 6. Changes in employment and benefits status measured by patient demographics questionnaire at baseline, 22 weeks, 44 weeks and 66 weeks, and actual end of treatment if different from 22 weeks. 7. Quality of life measured by the Recovering Quality of Life (ReQoL) at baseline, 22 weeks, 44 weeks and 66 weeks, and actual end of treatment if different from 22 weeks. 8. Therapist time involved in iCT-PTSD and TAU as measured by number of sessions and their duration. 9. Cost effectiveness of iCT-PTSD and TAU as measured by EuroQol EQ-5D-5L, Client Service Receipt Inventory, and iMTA Productivity Cost Questionnaire completed at baseline, 22 weeks, 44 weeks, 66 weeks, and actual end of treatment if different from 22 weeks. Process measures: 10. Treatment acceptability and patient satisfaction with treatment assessed with the NHS TT Patient Experience | — |
Countries
England, United Kingdom