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.: PACTR202108755066871 Date of Approval: 23/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PTSD Coach Study
Official scientific title A counsellor-supported ‘PTSD Coach’ intervention versus enhanced Treatment-as-Usual in a resource-constrained setting: A randomised controlled trial
Brief summary describing the background and objectives of the trial Posttraumatic stress disorder is a prevalent and impairing disorder, with data suggesting that most individuals in low- and middle-income countries have limited access to the needed treatments often due to resource constraints. Internet-based interventions, such as the freely available ‘PTSD Coach mobile application, may be one way to make services more accessible and efficient. To our knowledge this is the first time PTSD Coach (PC) is evaluated in a resource constrained setting such as South Africa. The overarching aim of the study is to assess the effectiveness of a clinician monitored PTSD Coach (PC) intervention on PTSD symptom reduction. We also aim to assess the effectiveness of the intervention on reducing co-morbid disorders and symptoms e.g., anxiety and depression. We aim to compare counsellor supported PTSD Coach (PTSD Coach-CS) with enhanced Treatment As Usual (e-TAU). In light of resource scarcity, this knowledge will be valuable in attempts at making PTSD treatment more timeous and accessible.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 30/08/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 62
Recruitment status Completed
Publication URL https://doi.org/10.1017/gmh.2023.92
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 Counsellor Supported Once a week for four weeks Four weeks Participants in the PTSD Coach-CS arm will attend four weekly sessions of 30-40min in duration each at the Faculty of Medicine and Health Science where they will be seen in a private office and supported by a volunteer counsellor. Participants within the PTSD Coach-CS arm will be supported and guided by volunteer counsellors trained in a standard method of providing support of PTSD Coach namely, assisting with language difficulties and mobile application usage only. 30
Control Group Enhanced Treatment as Usual As determined by the supported accessed As determined by the supported accessed After the first session, the independent evaluator will give each participant a detailed referral letter which includes: symptom profile and a request for psychological assistance at primary health care level. The project manager will contact the participant and ask that they access care at their local clinic. 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 will be made by the psychiatric nurse, medical officer, and/ or mental health staff at the clinic. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants (18 - 65 years) must be able to read and understand English, able to provide written informed consent, and able to attend weekly sessions (active study procedures and follow-ups) at the Faculty of Medicine and Health Science during office hours (Monday – Friday, 08:00 – 17:00). Basic English skills (trained volunteer counsellor in the event that they struggle with language and or technical aspects) Current diagnosis of PTSD Participants using psychotropic medications will be required to have been on a stable dose for at least 2 months before their pre-intervention assessment (T0) Participants with active alcohol or drug use disorder (past 6 months). High risk for suicide Presence of an organic disorder or cognitive impairment that will compromise uptake of the intervention. Participants will be withdrawn from the study if (i) there is a serious adverse event where the risks of continued participation outweigh the benefits; (ii) a participant is not capable of continuing the study (e.g., relocation) or (iii) a participant voluntarily decides to discontinue the study (withdraw). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Month(s) 65 Month(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 13/08/2021 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Franci van Zijl Drive Tygerberg 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess and compare the change in PTSD symptoms over the course of treatment and follow-up between the intervention arms (PTSD Coach-CS and e-TAU). Pre-intervention, post-intervention and one month follow- up - depending on funding 3/6month follow-up planned
Secondary Outcome To assess and compare the change in anxiety, and depression over the course of treatment and follow-up between the intervention arms. To assess and compare neurocognitive function alterations over the course of the intervention between the two arms. To track hair cortisol levels as a long-term neuroendocrine marker of PTSD symptom severity and treatment response between two treatment arms. To gather qualitative feedback from participants about their use of PTSD Coach to augment the quantitative findings. Pre-intervention, post-intervention and one month follow- up - depending on funding 3/6month follow-up planned
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine and Health Science Stellenbosch University Franci van Zijl Drive Tygerberg 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NRF Thuthuka Bursary Fund 7 Fricker Road Johannesburg South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine and Health Sciences Stellenbosch Unviersity Faculty if Medicine and Health Sciences, Franci van Zijl Drive Tygerberg 7505 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Miranda Olff 1012 WX Amsterdam Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Erine Brocker erineb@sun.ac.za +27210389587 Faculty of Medicine and Health Sciences, Franci van Zjl Drive
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa PhD Candidate
Role Name Email Phone Street address
Public Enquiries Erine Brocker erineb@sun.ac.za 27219389587 Faculty if Medicine and Health Sciences, Franci van Zijl Drive
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa PhD Candidate
Role Name Email Phone Street address
Scientific Enquiries Erine Brocker erineb@sun.ac.za +27219389587 Faculty if Medicine and Health Sciences, Franci van Zijl Drive
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa PhD Candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results of this study will be published and source data available upon reasonable request Study Protocol Results of this study will be published and source data available upon reasonable request Results of this study will be published and source data available upon reasonable request
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