Study to Prevent Negative Thoughts of Life

Sponsor

Institute for Research & Development Sri Lanka (Other)

Overall Status

Unknown status

CT.gov ID

NCT00862732

Collaborator

Institute of Psychiatry, London (Other)

Enrollment

Location

Arms

Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Active Suicidal Ideations	Behavioral: Cognitive behavioural therapy Other: Treatment as usual	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2009

Anticipated Primary Completion Date :

Nov 1, 2009

Anticipated Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Cognitive Behavioural Therapy 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.
Active Comparator: 2 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.	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.

Arm

Intervention/Treatment

Active Comparator: 1 Cognitive Behavioural Therapy

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.

Active Comparator: 2 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.

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.

Outcome Measures

Primary Outcome Measures

Presence of active suicidal ideations during the follow-up period [three months after the cessation of intervention]

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 [three months after the cessation of intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00862732

Other Study ID Numbers:

IRD/03-08

First Posted:

Mar 17, 2009

Last Update Posted:

Mar 17, 2009

Last Verified:

Mar 1, 2009

Keywords provided by , ,

active suicidal ideation

cognitive behavioural therapy

Sri Lanka

RCT

Additional relevant MeSH terms:

Suicidal Ideation

Study Results

No Results Posted as of Mar 17, 2009