Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202005563701405 Date of Approval: 19/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prediction and Prevention of Posttraumatic Stress Disorder in Trauma exposed Adults
Official scientific title Prediction and Prevention of Posttraumatic Stress Disorder in Trauma exposed Adults
Brief summary describing the background and objectives of the trial Although most people do not suffer from effects of trauma (i.e. physical or sexual assault, motor vehicle accidents) for longer than a few weeks, some do continue to suffer severe and on-going symptoms, such as those of posttraumatic stress disorder (PTSD). The importance of identifying those who may be at risk of developing PTSD and providing treatment as early as possible has been highlighted in recent years. Potential PTSD risk factors that have been identified include pre-trauma factors (i.e. previous trauma exposure), characteristics of the traumatic experience, post-trauma social support, as well as neurocognitive factors. Telomeres, the structures that cap and protect the ends of chromosomes, and allostatic load have also been associated with psychological stress, PTSD and other anxiety disorders. Growing evidence suggests that cognitive behavioural therapy (CBT) techniques delivered in the first days and weeks after injury can prevent the development of chronic PTSD. There is also evidence that web-based interventions can successfully treat mental health and behavioural problems. PTSD Coach Online and the mobile based PTSD Coach application are potential CBT-based prevention and treatment tools. They provide individuals with online tools for coping with sadness, anxiety, and other symptoms that people who have been through trauma can develop. Although the PTSD Coach application is meant to be used by those with PTSD, we plan to use it in the early aftermath of trauma, to determine whether it is a useful tool for preventing PTSD. This study aims to (i) identify factors (i.e. telomere Length, allostatic load, genetic factors, trait anxiety, neurocognition, gender) predictive of PTSD and other psychopathology following a traumatic event; and (ii) determine whether a brief internet-based early CBT based intervention (PTSD Coach), is successful in reducing the development of PTSD and other psychopathology following a traumatic event. Secondary aims will be to test the feasibility and acceptability of the PTSD Coach app in a South African sample.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PP PTSD
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2018
Actual trial start date 01/01/2019
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/12/2023
Anticipated target sample size (number of participants) 276
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
N 15 08 069 Stellenbosch University HREC
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PTSD Coach Once within two weeks of the traumatic event, and thereafter as needed 30 minutes at first visit. Thereafter, duration will depend on tool/s chosen. PTSD Coach Online and the mobile based PTSD Coach application (app) provide individuals with online tools for coping with sadness, anxiety, and other symptoms that people who have been through trauma can develop. Some tools are brief and can help one relax or improve mood, for example. Longer tools teach one how to tackle difficult problems, change thinking patterns, and take steps to achieve goals. They are useful in the management of acute distress and PTSD symptoms, and with sleep. The programme is freely accessible. Although meant to be used by those with PTSD, we plan to use it in the early aftermath of trauma, to determine whether it is a useful tool for preventing PTSD. 138
Control Group Treatment as usual Not applicable Referral to service providers 138 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Experience of a DSM-5 defined traumatic event in the previous two weeks • Willing and able to provide written informed consent • Between the ages of 18 and 64 years • Able to read and write in English or Afrikaans at 5th grade level • Current or past history of schizophrenia, bipolar disorder or other psychotic disorder as defined on the MINI • Any significant recent or previous severe head injury (defined as loss of consciousness for > 24 hours and/or post-traumatic amnesia) or mild traumatic brain injury (mTBI) • Chronic use of any psychotropic medication at the initial assessment (reported by participant/ obtained from hospital files) • Injury sequelae that would interfere with study participation according to the judgment of the investigator • Cognitive impairment (determined by the Montreal Cognitive Assessment (MoCA)). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/12/2015 Stellenbosch University HREC
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/05/2020 Stellenbosch University HREC
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/02/2020 Stellenbosch University HREC
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive, Trygerberg, 7505 Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PTSD 3, 6 and 12 months post trauma
Secondary Outcome Other psychopathology - depression, anxiety, sleep disturbances 3, 6 and 12 months post trauma
Secondary Outcome Feasability and Acceptability of the PTSD Coach App 3, 6 and 12 months post trauma
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Psychiatry Stellenbosch University Faculty of Medicine and Health Sciences Francie van Zyl Drive Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Council of South Africa Francie van Zyle Drive Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sharain Suliman Francie van Zyl Drive Cape Town 7505 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sharain Suliman sharain@sun.ac.za +27219389161 Francie van Zyl Drive
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Stellenbosch University Department of Psychiatry
Role Name Email Phone Street address
Public Enquiries Pamela Stevens stevenspam@sun.ac.za +27219389161 Francie van Zyl Drive
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Stellenbosch University Department of Psychiatry
Role Name Email Phone Street address
Scientific Enquiries Sharain Suliman sharain@sun.ac.za +27219389161 Francie van Zyl Drive
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Stellenbosch University Department of Psychiatry
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information