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.: PACTR202110484536189 Date of Approval: 29/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adaptation and pilot evaluation of Problem Management Plus Intervention(PM+) to address psychological distress caused by Covid-19 and other adversities amongst an amaXhosa sample in the Eastern Cape, South Africa
Official scientific title Adaptation and pilot evaluation of Problem Management Plus Intervention(PM+) to address psychological distress caused by Covid-19 and other adversities amongst an amaXhosa sample in the Eastern Cape, South Africa
Brief summary describing the background and objectives of the trial WHO has developed Problem Management Plus (PM+), which is aimed to reduce symptoms of psychological distress (anxiety, depression, posttraumatic stress disorder) among communities affected by trauma and adversities. PM+ consists of 5 sessions of evidence based psychotherapeutical techniques (cognitive behavioural therapy and problem solving therapy), and can be delivered by non-professional counsellors. PM+ has been widely studied ( Bryant et al., 2017), but no studies have yet adapted or evaluated PM+ for the Xhosa community. PM+ has the potential to create more access to psychological services in South Africa because it can be conducted by lay helpers at no cost for the client. The Objectives are: 1) To evaluate the feasibility, acceptability and preliminary effects of the culturally and contextually adapted PM+ within the Xhosa community during the COVID-19 pandemic in terms of mental health outcomes and day-to-day functioning 2) To identify barriers and facilitators to treatment engagement and adherence and opportunities for scaling up PM+ among the Xhosa community in South Africa
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Common mental disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/06/2023
Actual trial start date 01/06/2023
Anticipated date of last follow up 01/07/2023
Actual Last follow-up date 01/08/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 100
Recruitment status Not yet recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Problem Management Plus 5 sessions 5 days a week 90 minutes PM+ is a psychological intervention that aims to improve management of practical problems and associated psychological distress. It is a transdiagnostic intervention since it aims to address symptoms of distress, mood and anxiety disorders instead of focusing just on one problem. 30
Control Group Care As Usual 5 sessions 5 days 30-60 minutes Care as Usual consists of recommendation, psychological education and referral's and Cognitive Behavioral Therapy. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants who have identified problems in their lives Participants who identify themselves as members of the Xhosa ethnic group Participants must be adults aged 18+ Participants that have identified as imminent suicidal risk Participants that have severe mental disorders or cognitive impairment Participants that are receiving psychological treatment with specialized mental health care Adult: 19 Year-44 Year 18 Year(s) 70 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
No 14/10/2021 Nelson Mandela University Research Ethics Committee for Humans
Ethics Committee Address
Street address City Postal code Country
University Way Gqeberha 6001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To examine the feasibility and acceptability of the adapted PM 2023 June
Secondary Outcome To assess the RCT trial procedures in preparation of a future larger RCT evaluating the effectiveness of the adapted versions of PM+ November 2023
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Phelophepha Train Eloff Street Johannesburg 2001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Aviwe Zuziwe Nomalibongwe Tebekana 48 Saffrey Humansdorp 6300 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Not applicable Not applicable Not appblicable None South Africa None
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aviwe Zuziwe Nomalibongwe Tebekana avatebekana@gmail.com 0027646902544 48 Saffrey Street
City Postal code Country Position/Affiliation
Humansdorp 6300 South Africa PHD Candidate
Role Name Email Phone Street address
Public Enquiries Yaseen Ally yaseen.ally@mandela.ac.za 0027674083381 University Way
City Postal code Country Position/Affiliation
Gqeberha 2001 South Africa Promoter Supervisor
Role Name Email Phone Street address
Scientific Enquiries Marit Sijbrandij e.m.sijbrandij@vu.nl 0031205988360 7 Van der Boechorststraat
City Postal code Country Position/Affiliation
Amsterdam 1081 Netherlands Promoter Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual data identified during the trial after deidentification, Documents that will be available are: Study protocol, statistical analysis plan, informed consent form and thesis. Data will be available immediately after publication, Anyone who wishes to access the data will access the data. Data will be disseminated to achieve the aims in the approved proposal. Data will be available on the Nelson Mandela University data base. under the following link: http://vital.seals.ac.za:8080/vital/access/manager/Index?site_name=Nelson%20Mandela%20University Informed Consent Form,Study Protocol 2023-2024 Data will be accessed by: the PI the 2 promoters A qualified statistician at the Nelson Mandela University
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://vital.seals.ac.za:8080/vital/access/manager/Index?site_name=Nelson%20Mandela%20University 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