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.: PACTR202108609876315 Date of Registration: 06/08/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Internet-based treatment of PTSD.
Official scientific title A pilot and feasibility randomised control trial of a clinician monitored PTSD Coach Online intervention in a resource constrained setting
Brief summary describing the background and objectives of the trial Posttraumatic stress disorder (PTSD) is a prevalent and impairing disorder, with data suggesting that most individuals in developing countries have limited access to the treatments that they need. Internet based interventions, such as the freely available ‘PTSD Coach online’ (PCO), may be one way to make services more accessible and efficient. Since this is, to our knowledge, the first time PTSD Coach Online to be tested in a low resource setting such as South Africa, this study aims to consider the feasibility, acceptability and preliminary effectiveness effectiveness of a clinician monitored PTSD Coach Online intervention on PTSD symptom reduction. We aim to compare clinician supported PTSD Coach Online with Enhanced Treatment as Usual. This comparison has not previously been undertaken and certainly not in a low resource setting such as South Africa. In light of resource scarcity, this knowledge will be valuable in attempts at making PTSD treatment more accessible. Primary objectives • To assess the feasibility of clinician monitored PTSD Coach Online in a low resource setting such as South Africa. • To assess and compare the change in PTSD symptoms over the course of treatment and follow-up between two intervention arms
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PCO
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 31/05/2019
Actual trial start date 31/05/2019
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 10
Actual target sample size (number of participants) 10
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PTSD Coach Online Once a week 8 weeks PTSD Coach Online (PCO) is an online trauma-based intervention platform designed by the United States Department of Defence (DoD) and Veteran Affairs (VA) (https://www.ptsd.va.gov/apps/ptsdcoachonline/default.htm.). A counsellor with basic understanding of mental concepts, basic computer skills, a good grasp of the English language, was trained to provide language and technical support only to all participants in a standardised manner. 5
Control Group Enhanced Treatment as Usual As ascertained by individuals where care was accessed Monitored at baseline, mid-point at 4 weeks and post-intervention at 8 weeks. Participants receive a detailed referral letter which includes: symptom profile and a request for psychological assistance at primary health care level. The involved counsellor will also aim to establish contact with the psychiatric nurse or clinical manager to inform them of the referral. Further care decisions made by the psychiatric nurse, medical officer, and/ or mental health staff at the clinic. Participant will be followed-up by the volunteer counsellor regarding treatment accessed. 5 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Between the ages of 18 and 65 years Able to provide written informed consent Comfortable with laymen English Could attend weekly sessions at the university campus during office hours. Current diagnosis of PTSD, as indicated by the Mini-International Neuropsychiatric Interview 7.0 (M.I.N.I 7.0) Moderate to severe PTSD symptom severity as evident on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) If on psychotropic medications - stable dose for at least two months pre-study enrolment if able to maintain a stable dose until post-pilot study procedures. Participants with DSM-5 current substance use disorder (past 6 months), as assessed by the M.I.N.I. Considered at high risk for suicide (as determined on the MINI) Presence of an organic disorder or cognitive impairment that will compromise uptake of the intervention. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 06/05/2019 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Franci van Zijl Tygerberg 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The feasibility, acceptability and utility of PTSD Coach Online in our setting. Baseline, mid-point at 4 weeks and post-intervention at 8 weeks.
Secondary Outcome Changes in PTSD symptom severity by means of the CAPS-5 Baseline, mid-point at 4 weeks and post-intervention at 8 weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine and Health Sciences Steelnbosch University Franci van Zijl Drive Tygerberg 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Harry Crossley Foundation for 2018 Franci van Zijl Tygerberg 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stellenbosch University Fanci van Zijl Drive Tygerberg 7505 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Soraya Seedat Faculty of Medicine and Health Sciences, SU Tygerberg 7505 South Africa
Sharain Suliman Faculty of Medicine and Health Sciences, SU Tygerberg 7505 South Africa
Miranda Olff Centre for Psychological Trauma at the department of Psychiatry at the Amsterdam UMC Amsterdam 1000 BP Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Erine Brocker erineb@sun.ac.za +27219389587 Clinical Building, Faculty of Medicine and Health Sciences, Stellenbosch University
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa Clinical Psychologist researcher and PhD Candidate
Role Name Email Phone Street address
Public Enquiries Erine Brocker erineb@sun.ac.za +27219389587 2nd Floor Clinical Building, Faculty of Medicine and Health Sciences, Stellenbosch University
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa Clinical Psychologist researcher and PhD Candidate
Role Name Email Phone Street address
Scientific Enquiries Erine Brocker erineb@sun.ac.za +27219389587 Clinical Building, Faculty of Medicine and Health Sciences, Stellenbosch University
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa Clinical Psychologist researcher and PhD Candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data sharing is available from the principal investigator based on reasonable request Informed Consent Form,Statistical Analysis Plan,Study Protocol Available since data collection is complete Data sharing is available from the principal investigator based on reasonable request from reviewers and researchers. Requests is controlled and will be screened and evaluated by both the principal investigator and involved supervisors.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 06/08/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 06/08/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information