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SLCTR Registration Number
SLCTR/2011/003
Date of Registration
The date of last modification
Mar 27, 2013
View original TRDS
Trial Status
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
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
Status
Date of Approval
Approval number
Details of Ethics Review Committee
Name: | |
Institutional Address: | |
Telephone: | |
Email: |
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
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