Post-traumatic stress disorder Mental and Behavioural Disorders Post-traumatic stress disorder
Conditions
Interventions
Participants’ symptoms of PTSD, depression, anxiety and functioning are assessed and they are randomised (minimisation with a random component) at a 3:3:1 ratio to either:
1. Internet-delivered cognit
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and above 2. Diagnosis of Posttraumatic Stress Disorder (as assessed with the Structured Clinical Interview for DSM-5) 3. The current reexperiencing symptoms are linked to one or two discrete traumatic events experienced in adulthood. Updated 05/11/2019: Their current reexperiencing symptoms are linked to one or two discrete traumatic events that they experienced in adulthood or adolescence, or several traumatic episodes during a longer period of high threat (e.g., domestic abuse, war zone experiences) 4. PTSD is the main psychological problem needing treatment 5. Willing and able to provide informed consent 6. Able to read and write in English 7. Access to internet 8. Willing to be randomly allocated to one of the psychological treatments or wait 9. If taking psychotropic medication, the dose must be stable for at least 1 month before randomisation 10. If currently receiving psychological therapy for PTSD, this treatment must have ended before randomisation
Exclusion criteria
Exclusion criteria: 1. History of psychosis 2. Current substance dependence 3. Current borderline personality disorder 4. Acute serious suicide risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PTSD symptoms measured with PTSD Symptom Checklist 5 at baseline, 6, 13 weeks after random allocation (with follow-ups at 26, 39 and 65 weeks), and weekly during treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessor ratings of PTSD symptoms, assessed with the Clinician Administered PTSD Scale for DSM 5 (CAPS-5) at baseline and 13 weeks after random allocation (with follow-ups at 26, 39 and 65 weeks). 2. Other symptom measures assessed at baseline, 6, 13 weeks after random allocation (with follow-ups at 26, 39 and 65 weeks), and weekly during treatment: 2.1. Depression, assessed with the Patient Health Questionnaire (PHQ-9) 2.2. Anxiety, assessed with the Generalized Anxiety Disorder Scale 7-items (GAD-7) 2.3. Disability, assessed with the Work and Social Adjustment Scale (WSAS) 2.4. Sleep problems, assessed with the Insomnia Sleep Index (ISI) 2.5 Well-being, assessed with the WHO-Five Wellbeing-Scale (added 05/11/2019) 2.6. Quality of life, assessed with the Endicott Quality of Life Scale (added 05/11/2019) 3. Health economics measures (Euroqol EQ-5D-5L12, iMTA Productivity Cost Questionnaire (PCQ), Endicott Quality of Life Scale (QoL), Client Service Receipt Inventory (CSRI), employment status and state benefits), assessed at baseline, 13, 26 and 39 weeks 4. Process measures assessed at baseline, 6, 13, 26, 39 weeks after random allocation (and some weekly during treatment): 4.1. Excessively negative appraisals, assessed with the Posttraumatic Cognitions Inventory (PTCI), short version 4.2. Disjointed memories, assessed with the Trauma Memory Questionnaire (MQ), short version 4.3. Unhelpful strategies to deal with intrusive memories, assessed with the Response to Intrusion Questionnaire (RIQ) 4.4. Safety behaviours, assessed with the short version Safety Behaviours Questionnaire (SBQ) 4.5. Dissociation, assessed with the short version State-Trait Dissociation Questionnaire (TSDQ) 4.6. Self-efficacy, assessed with the short version Generalized Self Efficacy Scale (GSES) Other process measures: 1. Therapeutic alliance, assessed using the Working Alliance Inventory (WAI) at weeks 2 and 6 2. Patient satisfaction and comments on their experience with online therapy, | — |
Countries
England, United Kingdom
Contacts
Public ContactPoppy Green
Outcome results
None listed