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

23 Mar 2017

The date of last modification

Jan 29, 2019



Application Summary


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)


Trial Details


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)

  1. Employment as nursing officers in the study sites for the duration of the study
  2. Voluntary participation

Component B

  1. Males and females aged 16 years and above
  2. Admitted for medical management of non-fatal (attempted) self-poisoning

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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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