PTSD Experimental Treatment Trial (PETT): Comparing two talking therapies for the treatment of post-traumatic stress disorder in UK military veterans
- Conditions
- Post-traumatic stress disorder (PTSD)Mental and Behavioural Disorders
- Registration Number
- ISRCTN10314773
- Lead Sponsor
- King's College London
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37833734/ (added 16/10/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Current inclusion criteria as of 19/04/2021:
1. Adults aged =18 years
2. UK military veterans from the Army, Royal Air Force or Royal Navy
3. PTSD (acute or chronic) diagnosis determined by DSM-5 using the Clinician Administered PTSD scale (CAPS-5) during clinical assessment with an Inspire (trial’s participating partner) employed clinical psychologist
4. Experiencing symptoms causing clinically significant distress or impact on social, occupational or other areas of functioning
5. A history of exposure to one or more traumas
6. Living or working in the United Kingdom
7. Willingness to be randomised to either treatment
Previous inclusion criteria from 05/11/2019 to 19/04/2021:
1. Adults aged =18 years
2. UK military veterans from the Army, Royal Air Force or Royal Navy
3. PTSD (acute or chronic) diagnosis determined by DSM-5 using the Clinician Administered PTSD scale (CAPS-5) during clinical assessment with an Inspire (trial’s participating partner) employed clinical psychologist
4. Experiencing symptoms causing clinically significant distress or impact on social, occupational or other areas of functioning
5. A history of exposure to one or more traumas
6. Living or working in Northern Ireland and within 20 miles of one of Inspire’s treatment centres which are spread across remote NI
7. Willingness to be randomised to either treatment
Previous inclusion criteria:
1. Adults aged =18 years
2. UK military veterans from the Army, Royal Air Force or Royal Navy
3. PTSD or complex PTSD diagnosis (acute and/or chronic) according to DSM-5 using the Clinician Administered PTSD Scale (CAPS-5) and the ICD-TQ determined during clinical assessment with an Inspire (trial's participating partner) employed consultant clinical psychologist
4. Experiencing symptoms causing clinically significant distress or impact on social, occupational or other areas of functioning
5. A history of exposure to one or more traumas
6. Living or working in Northern Ireland and within 20 miles of one of Inspire’s treatment centres which are spread across remote NI
7. Willingness to be randomised to either treatment
Current exclusion criteria as of 05/11/2019:
1. Serving military personnel
2. Currently receiving psychological treatment for PTSD
3. Currently has a comorbid DSM-5 mental health or personality disorder sufficiently severe as to intrude upon the participant’s ability to cooperate with treatment
4. Current addiction to alcohol or illegal substances as determined by an AUDIT 10 cut-off of =20
5. Participants who had a suicide attempt within the past month at time of recruitment
6. Not able to provide informed consent
7. Self-reported medication changes in the previous 4 weeks
8. Unwilling to consent to audio-recording of all therapy sessions as minimum requirement
Previous exclusion criteria:
1. Serving military personnel
2. Currently receiving psychological treatment for PTSD
3. Currently has a comorbid DSM-5 mental health or personality disorder sufficiently severe as to intrude upon the participant’s ability to cooperate with treatment
4. Current addiction to alcohol or illegal substances as determined by an AUDIT 10 cut-off of =20
5. Participants who had a suicide attempt within the past month at time of recruitment
6. Not able to provide informed consent
7. Self-reported medication changes in the previous 4 weeks
8. Refusing to be audio recorded, which is required for treatment fidelity and data analysis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Feasibility will be assessed using the following outcome measures:<br>1.1. Numbers of potential participants who are referred or self-refer to the Clinical Psychologists for eligibility assessment<br>1.2. The number of people who consent to participate and are randomised to either treatment<br>1.3. The number of people who remain in treatment <br>1.4. The time when people drop out <br>1.5. The number of people who remain in the research irrespective of whether they remain in treatment. <br>2. The cost of treatment will be assessed using the following outcome measures:<br>2.1. The number and duration of therapy sessions and the therapist used<br>2.2. The cost of any patient safety measures used during treatment and up to the 20-week follow up point.
- Secondary Outcome Measures
Name Time Method