None listed
Conditions
Brief summary
The project aims to evaluate the acceptability and clinical efficacy of the online PTSD program; and to examine the role of intolerance of uncertainty and emotion regulation in PTSD symptom change following the PTSD Program. Up to 144 people with PTSD will be randomly assigned to either the active treatment group or a waitlist control group. The treatment group will commence the PTSD program immediately, whereas the waitlist control group will commence once the treatment group has completed. PTSD program efficacy will be determined by comparing the PTSD symptom levels of each group at the time the treatment group completes treatment. The role of intolerance of uncertainty and emotion regulation in PTSD symptom change will be examined using mediation analysis.
Interventions
The internet PTSD program comprises 6 lessons completed over 10 weeks. It includes all treatment components
typically seen in face-to-face cognitive behavioural therapy (CBT) (the first-line treatment for PTSD). One lesson will be completed every 7 to 14 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons and a maximum of 14 days). Each lesson will take approximately 20-30 minutes to complete. Participants will have access to
The internet PTSD program comprises 6 lessons completed over 10 weeks. It includes all treatment components typically seen in face-to-face cognitive behavioural therapy (CBT) (the first-line treatment for PTSD). One lesson will be completed every 7 to 14 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons and a maximum of 14 days). Each lesson will take approximately 20-30 minutes to complete. Participants will have access to summaries of each lesson, homework exercises, extra resources, email contact from the clinician (registered clinical psychologist) after completion of the first two lessons, then as required. The participant is also able to email or phone the clinician at any point during the trial as required. The participant completes a measure of psychological distress before each lesson and if their scores increase by one or more standard deviations the clinician is automatically alerted and initiates contact with the participant by phone or email. Strategies used to improved adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework, collection of data on how long participants spent reading lessons and practicing skills.
Sponsors
St Vincent's Hospital, Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Self-identified as suffering from PTSD/experienced a major trauma - Meet criteria for PTSD as determined by the Mini International Neuropsychiatric Interview Version 5.0.0 (MINI; Sheehan et al., 1998) - Australian residential status - At least 18 years of age - Access to a computer, internet and printer - If taking medication, must have been taking the same dose for at least 1 month and not intend to change that dose during the course of the program - Prepared to provide name, phone number and address, and to provide the name and address of a local general practitioner - Willing to provide written informed consent
Exclusion criteria
- Does not meet PTSD diagnostic criteria - Trauma occurrence within the past 4 weeks - Currently participating in CBT or other treatment for trauma or PTSD - Currently highly dissociative (indicated by score greater than or equal to 40 on the Dissociative Experiences Scale) - Current or pending medicolegal proceedings associated with the reported trauma - Applying for or receiving Workers Compensation associated with their trauma or PTSD - Regularly using illicit drugs or regularly consuming more than three standard drinks per day - Current regular use of benzodiazepines - Currently experiencing a psychotic mental illness or bipolar disorder - Severe symptoms of depression (defined as a total score of at least 22 or responding at least ‘2’ to Question 9 (suicidal ideation) on the Patient Health Questionnaire_9 Item (PHQ-9) will require risk assessment with the responsible clinician before being admitted into the study
Outcome results
None listed