Post-traumatic stress disorder (PTSD) Mental and Behavioural Disorders
Conditions
Interventions
Using King's College London Clinical Trials Unit's computer randomisation service, 60 participants will be allocated on a 2:1 ratio to either Reconsolidation of Traumatic Memories (RTM) or Trauma-Focu
it is maintained in its current state. If circumstances have intensified, the impact of the memory may become worse
re-traumatization can add to the intensity of trauma memories. If the new circumstance provides evidence that a threat of negative emotional stimulus is no longer relevant, the strength of the affecti
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility will be assessed using the following outcome measures: 1.1. Numbers of potential participants who are referred or self-refer to the Clinical Psychologists for eligibility assessment 1.2. The number of people who consent to participate and are randomised to either treatment 1.3. The number of people who remain in treatment 1.4. The time when people drop out 1.5. The number of people who remain in the research irrespective of whether they remain in treatment. 2. The cost of treatment will be assessed using the following outcome measures: 2.1. The number and duration of therapy sessions and the therapist used 2.2. The cost of any patient safety measures used during treatment and up to the 20-week follow up point. | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary outcome measures will be used at baseline and then 6, 12, 20 and 52 weeks post-randomisation. 1. PTSD symptoms assessed using the PTSD checklist for DSM 5 (PCL-5). This is the likely primary outcome in the subsequent fully powered tria. 2. Impact of the participants' mental health on work, home, social and private leisure activities and interpersonal relationships assessed using the Work and Social Adjustment Scale (WSAS) 3. Recovery from psychosis or mental health problem assessed using the Quality of Process of Recovery scale (QPR) 4. Depression assessed using the Patient Health Questionnaire (PHQ), a self-administered diagnostic instrument 5. Anxiety assessed using the General Anxiety Disorder score sheet (GAD-7) 6. Health status assessed using the EQ5D-5L, a two-page questionnaire with page one consisting of the EQ-5D descriptive system and page two the EQ visual analogue scale (EQ VAS) 7. Health and social services utilisation in terms of number of contacts with general practice, social services, mental health services and other agencies during the past specified period assessed using the FolATED (Use of health and social-service questionnaire), which is a 31-item administered questionnaire 8. Acceptability of both treatments assessed using qualitative interviews with 15-20 participants in both RTM and TF-CBT groups to determine the acceptability and feasibility of participating in the trial and the treatment they received | — |
Countries
Northern Ireland, United Kingdom
Contacts
Public ContactRebecca Rogers
Outcome results
None listed