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Original TRDS for trail "Developing a psychological and social management package and assessing its' benefits among snakebite victims" created on Mar 27, 2013


SLCTR Registration Number

SLCTR/2011/003


Date of Registration

26 Jan 2011

The date of last modification

Mar 27, 2013


View original TRDS


Trial Status



Application Summary


Scientific Title of Trial

Development and assessment of a psycho-social intervention for snake bite victims


Public Title of Trial

Developing a psychological and social management package and assessing its' benefits among snakebite victims


Disease or Health Condition(s) Studied

Depressive disorder, Post traumatic stress disorder , Somatization among snake bite victims


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

None


Trial Details


What is the research question being addressed?

Can a brief psycho-social intervention reduce psychological morbidity among snakebite victims ?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Uncontrolled


Assignment

Parallel


Purpose

Prevention


Study Phase


Intervention(s) planned

Setting: Snake bite victims will be recruited at the time of the bite from medical wards of the Polonnaruwa and Kurunegala general hospitals. Duration The total duration of the study will be 24 months. Data collection will start from January 2011. Study Sample All snake bite victims admitted to the above hospitals during the stipulated time period and identified as being envenomed and requiring treatment with anti-venom will be eligible for the study. The recruits will then be randomized into three groups. Group 1 will be managed as at present and will receive no specific psycho-social intervention. This group will act as a control to the other groups receiving psycho-social interventions. The second group will receive a brief intervention in the form of psychological first aid and psycho-education at the time of discharge from hospital. The third group will receive the above brief intervention on discharge as well as a brief intervention for post traumatic stress disorder one month following the snakebite. All three groups will be assessed for psychological morbidity at one month and six months post snake bite, and the effectiveness of the psychological interventions evaluated• Group 1- Normal management (No psychological intervention) • Group 2 – Normal management + Psychological first aid + Psycho-education • Group 3 – Normal management + Psychological first aid + Psycho-education + Brief intervention for PTSD The psycho-social interventions will be conducted by trained pre-intern doctors. The rationale behind this is that we wish to develop a psychological intervention that can be administered by primary care physicians or junior ward doctors. The doctors conducting the intervention will be trained formally by a Psychiatrist on aspects pertaining to communication skills, specific psychological interventions and ethical issues in dealing with patients. The specific types of psycho-social interventions provided will include: 1) Psychological First Aid: • Comfort and consolation • Sharing experience • Facilitating a sense of being in control • Identification of those in need of further help 2) Psycho-education: • Discuss patients perceptions of snake bite and tackle myths related to snakebite and it’s consequences. • Educate patients and relatives on the actual physical impact of snakebite and when to seek medical help. • Make patients and family members aware of psychological symptoms of depression and post traumatic stress disorder and when to seek appropriate help. • Educate on maladaptive coping methods such as avoidance behavior and maintenance of sick role seen following snake bite and the importance of rehabilitation within community. • Brief trauma focused cognitive behavior therapy. 3) Brief Intervention for post traumatic stress disorder: • Trauma based cognitive behaviour therapy


Inclusion criteria

Snakebite victims admitted to the Polonnaruwa General Hospital and Kurunegala Teaching Hospital with evidence of envenoming.


Exclusion criteria

Those with preexisting psychiatric disorders.



Primary outcome(s)

1.

Differences in Score of Hopkins symptoms checklist among three groups. Differences in score of Modified Becks depression inventory among three groups. Differences in score of Sheehan disability inventory among three groups. Differences in scores of Post traumatic stress disorder symptom scale among three groups.

[

At one month and six months post snakebite.

]

Secondary outcome(s)

1.

Effect on employment status Effect on social life

[

One month and six months post snakebite

]

Target number/sample size

195 ( 65 snakebite victims in each group)


Countries of recruitment

Sri Lanka


Anticipated start date

2011-02-01


Anticipated end date

2012-12-31


Date of first enrollment


Date of study completion


Recruitment status

Recruiting


Funding source

South Asian Clinical toxicology Research collaboration (SACTRC)


Regulatory approvals



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. C. A. Wijesinghe
Lecturer, Department of Psychiatry, Faculty of Medicine,
P.O.Box 115 , Faculty of Medicine Ragama
0714818034/0112961115 0112961118


chamawij@hotmail.com

Contact Person for Public Queries

Dr. C. A. Wijesinghe
Lecturer, Department of Psychiatry, Faculty of Medicine,
P.O.Box 115 , Faculty of Medicine Ragama
0714818034/0112961115 0112961118


chamawij@hotmail.com


Primary study sponsor/organization

South Asian Clinical toxicology Research collaboration (SACTRC)

Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka
+94812384556 +94814479822


contact@sactrc.org

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results