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.: PACTR202011530106411 Date of Approval: 27/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of brief coping skill training on alcohol use in high risk student drinkers
Official scientific title Effect of brief coping skill training on alcohol use in high risk student drinkers.
Brief summary describing the background and objectives of the trial Background: Negative affective states such as anxiety and depression are commonly associated with alcohol related problems. Researchers have recognized alcohol consumption may be motivated by alcohol's ability to alter emotional states. Self-reported drinking to cope with negative emotions/experiences underpins a risk of alcohol dependence Objectives: To provide undergraduate students with behavioural intervention (Episodic Future Thinking) compared to control "Episodic Recent Thinking" to better cope with emotional issues that may lead them to drink more.
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 Education /Training
Anticipated trial start date 01/02/2021
Actual trial start date
Anticipated date of last follow up 01/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
13345 Stellenbosch University - Human Research Ethics Committee
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 by using procedures such as coin-tossing or dice-rolling Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Episodic Future Thinking Once a day 2 weeks EFT is a technique that trains you to imagine an experience that may occur in the future and train you to pre-experience the moment to reduce alcohol consumption 32
Control Group Episodic Recent Thinking once a day 2 weeks Participants in this control group will be shown a funny animal video and will be trained to use an established mood regulation technique to make them feel pleasure as a result of watching the video 32 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged between 18-25 years old. ≥ 5 items scored above 0 (“never”) on Drinking Motives Checklist (DMC) to identify drinking to cope with negative affect. Score ≥ 8 on Alcohol Use Disorder Identification Test (AUDIT) to identify hazardous drinking. Aged over 25 years < 5 items scored below 0 ("never") on Drinking Motives Checklist (DMC) Score < 8 for Alcohol Use Disorder Identification Test (AUDIT) Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 25 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 06/08/2020 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Stellenbosch University, Francie van Zijl Drive, Health Research Ethics Committee Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Participants in EFT group will have greater improvements in alcohol dependence compared to control group 2 and 4 weeks
Secondary Outcome Participants in EFT group will have better coping mechanisms to deal with negative life events that may lead to depression and anxiety later in life 2 and 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Stellenbosch University Faculty of Medicine and Health Science Stellenbosch University, Francie van Zijl Drive, Department of Psychiatry Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stellenbosch University Stellenbosch University, Faculty of Medicine and Health Science, Francie van Zijl Drive, Department of Pscyhiatry Cape Town 7505 South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Soraya Seedat sseedat@sun.ac.za +27219389227 Stellenbosch University, Faculty of Medicine and Health Science, Francie van Zijl Drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Executive Head of Department of Psychiatry
Role Name Email Phone Street address
Public Enquiries Fatima Ahmed fahmed@sun.ac.za +27219389085 Stellenbosch University, Faculty of Medicine and Health Science, Education Building 5063, Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Research Assistant
Role Name Email Phone Street address
Public Enquiries Letitia Butler Kruger lbk@sun.ac.za +27219389228 Stellenbosch University, Faculty of Medicine and Health Science, Department of Psychiatry, Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Research Assistant
Role Name Email Phone Street address
Scientific Enquiries Soraya Seedat sseedat@sun.ac.za +27219389227 Stellenbosch University, Faculty of Medicine and Health Science, Department of Psychiatry, Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Executive Head of Department of Psychiatry
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Group-level summary statistics and findings will be shared within 12 months of study completion Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of study completion 1. Any researcher may request access to these data. 2. Interested researchers can email the research team their data requests. 3. A data request form will then be sent on to interested researchers to complete. 4. The research team will collectively approve these requests. 5. The criteria for approving these requests will include 1. Scientific validity 2. Detailed data management plan and capacity to analyse the data 2. Qualifications of the researcher (minimum Masters level) 3. Ethical considerations and compliance with the original IRB approval.
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