Study to Prevent Negative Thoughts of Life

Active Suicidal Ideations Clinical Trial

Official title:

A Randomised Controlled Trial With Cognitive Behavioural Therapy for Persons With Active Suicidal Ideations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00862732
• Other study ID #: IRD/03-08
• Status: Not yet recruiting
• Phase: N/A
• First received: March 16, 2009
• Last updated: March 16, 2009
• Start date: March 2009
• Est. completion date: November 2009

Study information

• Verified date: March 2009
• Source: Institute for Research & Development Sri Lanka
• Contact: Sudath Samaraweera, MBBS MSc MD
• Phone: +94777903407
• Email: sudath.samara[@]gmail.com
• Is FDA regulated: No
• Health authority: Sri Lanka: Ministry of Healthcare & NutritionUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to test whether cognitive behaviour therapy (CBT) offered by trained therapists, to people with current active suicidal ideations, is efficacious as a secondary prevention strategy in Sri Lanka, when compared with treatment as usual provided by Medical Officers (Mental Health; MO (MH)) of government hospitals

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Age between 18 - 64 years

• Self reported current active suicidal ideations

• Ability to speak and write Sinhala

Exclusion Criteria:

• An acute intent and planning of suicide

• In-patient/out-patient treatment following an attempted suicide during the previous two-year period

• A diagnosis of mental retardation

• A diagnosis of sensory deficit

• A diagnosis of alcohol abuse

• A diagnosis of psychotic illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Active Suicidal Ideations
• Suicidal Ideation

Intervention

Behavioral:
• Cognitive behavioural therapy
Will receive a series of sessions of cognitive behaviour therapy. Delivery of CBT will be by three therapists; PI and two other Medical Officers. Each session will last for 30- 45 minutes and they will be delivered at the participant's residence (or at an alternative place of participant's choice) at two weeks intervals. They will be followed-up for three months from the cessation of CBT sessions.

Other:
• Treatment as usual
Will be referred to the MO(MH). They also will be followed-up for an equal length of time period as of the participants in the intervention group.

Locations

Country	Name	City	State
Sri Lanka	Institute for Research & Development	Battaramulla

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Research & Development Sri Lanka	Institute of Psychiatry, London

Country where clinical trial is conducted

Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of active suicidal ideations during the follow-up period		three months after the cessation of intervention	No
Secondary	Impulsiveness Suicide attempts and completed suicides Client satisfaction Probability of common mental disorders Adherence to treatment regime Retention in the treatment regime Quality of life		three months after the cessation of intervention	No