Study to Prevent Negative Thoughts of Life - Full Text View

Sponsors and Collaborators:	Institute for Research & Development Sri Lanka Institute of Psychiatry, London
Information provided by:	Institute for Research & Development Sri Lanka
ClinicalTrials.gov Identifier:	NCT00862732

Purpose

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

Condition	Intervention
Active Suicidal Ideations	Behavioral: Cognitive behavioural therapy Other: Treatment as usual

MedlinePlus related topics: Mental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomised Controlled Trial With Cognitive Behavioural Therapy for Persons With Active Suicidal Ideations

Further study details as provided by Institute for Research & Development Sri Lanka:

Primary Outcome Measures:

Presence of active suicidal ideations during the follow-up period [ Time Frame: three months after the cessation of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: three months after the cessation of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	68
Study Start Date:	March 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Cognitive Behavioural Therapy: Active Comparator Intervention group 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.	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.
2 Treatment as usual: Active Comparator 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.	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.

Arms

Assigned Interventions

1 Cognitive Behavioural Therapy: Active Comparator

Intervention group 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.

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.

2 Treatment as usual: Active Comparator

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862732

Contacts

Contact: Sudath Samaraweera, MBBS MSc MD

+94777903407

sudath.samara@gmail.com

Locations

Sri Lanka
Institute for Research & Development
Battaramulla, Sri Lanka

Sponsors and Collaborators

Institute for Research & Development Sri Lanka

Institute of Psychiatry, London

Investigators

Principal Investigator:

Sudath Samaraweera, MBBS MSc MD

Institute for Research & Development Sri Lanka

More Information

No publications provided

Responsible Party:	Institute for Research & Development ( Dr Sudath Samaraweera, Principal Investigator )
Study ID Numbers:	IRD/03-08
Study First Received:	March 16, 2009
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00862732 History of Changes
Health Authority:	Sri Lanka: Ministry of Healthcare & Nutrition; United Kingdom: Research Ethics Committee

Keywords provided by Institute for Research & Development Sri Lanka:

active suicidal ideation
cognitive behavioural therapy
Sri Lanka
RCT

ClinicalTrials.gov processed this record on May 07, 2009