Home » Trials » SLCTR/2017/008
A brief intervention for prevention of repetition of self-harm, among those who have recently attempted self-poisoning – a randomized controlled trial
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SLCTR Registration Number
SLCTR/2017/008
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A brief intervention for prevention of repetition of self-harm, among those who have recently attempted self-poisoning – a randomized controlled trial
Public Title of Trial
A brief intervention for prevention of repetition of self-harm, among those who have recently attempted self-poisoning – a randomized controlled trial
Disease or Health Condition(s) Studied
Non-fatal self-poisoning
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1194-2959
Any other number(s) assigned to the trial and issuing authority
16-052 (NRC Grant number) 2016/EC/81 (ERC: Peradeniya)
What is the research question being addressed?
What is the efficacy and acceptability of a brief intervention in preventing repetition of self-harm over one year and improving coping skills, reducing depression and alcohol misuse in those who have recently attempted self-poisoning?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out at the toxicology ward, Teaching Hospital Peradeniya, and the medical wards of one selected peripheral hospital.
The intervention consists of a brief, structured nurse-delivered mental health intervention focused on development of coping skills and distress tolerance abilities among participants. It has been developed based on the C-MAP intervention (culturally based manually-assisted problem solving training) recently trialed in Pakistan, for prevention of self-harm.
The study will have two components
Component A
Selected nursing officers will be trained to deliver the brief intervention. Training will be in the form of 2 workshops, conducted by the principal investigators prior to start of the study, and will include demonstrations, role play, and a discussion of identification and management of any risks. A short, structured manual will also be provided for the nurses to use as a guide, when delivering the intervention. On going support from the investigators will be available for the duration of the intervention.
Component B
Consenting participants meeting inclusion/exclusion criteria will be randomized into 2 arms using block randomization.
Arm 1 (intervention arm) will receive a single conversational session of by a trained nursing officer in a confidential setting, while still in hospital, but after recovery from the acute symptoms of poisoning
The main focus of the intervention is to help the participant understand reasons for their self-poisoning behaviour, followed by exploration of alternate methods of dealing with such crisis situations, for e.g., via strengthening of coping skills, distress tolerance abilities, and distraction and relaxation strategies. At the end of the discussion the participant will also be given a brief, written ‘take home message’, which sums up the main conclusions of the session. Each session will last 20 - 30 minutes.
Medical care in accordance with standard protocols will be provided to all participants
Arm 2 (control arm) will only receive medical care in accordance with standard protocols
Current treatment does not include mandatory psychiatric assessment of all patients who self-harm; however patients from both arms may be referred for psychiatric assessment and care at the discretion of the medical team.
Inclusion criteria
Component A (Nurses)
Component B
Exclusion criteria
Component A (Nurses): no exclusion criteria identified
Component B
1. Diagnosed mental illness such as schizophrenia / psychotic disorder, bipolar affective disorder, dementia, mental retardation or cognitive impairment
2. Patients who are physically too unwell to participate in the interview prior to discharge from hospital.
Primary outcome(s)
|
1.
Assessment of coping skills (via the Brief-COPE inventory) |
[ At baseline, and at 6 months and 12 months after delivery of the intervention ] |
|
2.
Level of alcohol use (via the Alcohol Use Disorders Identification Test - AUDIT) |
[ At baseline, and at 6 months and 12 months after delivery of the intervention ] |
|
3.
Depression (via the Patient Health Questionnaire 9 - PHQ-9 and the Peradeniya Depression Scale-PDS) |
[ At baseline, and at 6 months and 12 months after delivery of the intervention ] |
|
4.
Rate of repetition of self-harm (by any method, irrespective of degree of suicidal intent). |
[ At baseline, and at 6 months and 12 months after delivery of the intervention ] |
|
5.
Level of suicidal intent associated with any repetition of self-harm (via the Pierce Suicide Intent Scale - PSIS) |
[ At baseline, and at 6 months and 12 months after delivery of the intervention ] |
Secondary outcome(s)
|
1.
Acceptability, feasibility and usefulness of the brief psychological intervention – Assessed in the nurses and the participants. Assessment will be via qualitative measures (in-depth interviews and focus-group discussions) |
[ At 6 months and 12 months after completion of delivery of the intervention for all participants ] |
Target number/sample size
300 (150 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-03-27
Anticipated end date
2018-06-15
Date of first enrollment
2017-05-02
Date of study completion
Recruitment status
Recruiting
Funding source
National Research Council, Sri Lanka (Grant no: 16-052)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-01-27
Approval number
2016/EC/81
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Thilini Rajapakse
Senior Lecturer
Department of Psychiatry, Faculty of Medicine, University of Peradeniya, Sri Lanka
Mob: 0777386232
gemba471@gmail.com
https://med.pdn.ac.lk/departments/psychiatry/staff/rajapaksa.html
Contact Person for Public Queries
Lakmini de Silva
Research Assistant
South Asian Clinical Toxicology Research Collaboration
Faculty of Medicine
University of Peradeniya
Mob: 0774789435
lakminidesilva@yahoo.com
Primary study sponsor/organization
National Research Council, Sri Lanka
No 120/7, Vidyamawatha, Colombo 07
Tel: 0112675176
nrc@sltnet.lk
www.nrc.gov.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
