Study to Prevent Negative Thoughts of Life

NCT ID: NCT00862732

Last Updated: 2009-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Active Suicidal Ideations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cognitive behavioural therapy

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Psychiatry, London

OTHER

Sponsor Role collaborator

Institute for Research & Development Sri Lanka

OTHER

Sponsor Role lead

Responsible Party

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Institute for Research & Development

Principal Investigators

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Sudath Samaraweera, MBBS MSc MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Research & Development Sri Lanka

Locations

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Institute for Research & Development

Battaramulla, , Sri Lanka

Site Status

Countries

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Sri Lanka

Central Contacts

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Sudath Samaraweera, MBBS MSc MD

Role: CONTACT

+94777903407

Other Identifiers

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IRD/03-08

Identifier Type: -

Identifier Source: org_study_id

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