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Study to Prevent Negative Thoughts of Life

Primary Purpose

Active Suicidal Ideations

Status
Unknown status
Phase
Not Applicable
Locations
Sri Lanka
Study Type
Interventional
Intervention
Cognitive behavioural therapy
Treatment as usual
Sponsored by
Institute for Research & Development Sri Lanka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Active Suicidal Ideations focused on measuring active suicidal ideation, cognitive behavioural therapy, Sri Lanka, RCT

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute for Research & Development

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 Cognitive Behavioural Therapy

2 Treatment as usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Presence of active suicidal ideations during the follow-up period

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

Full Information

First Posted
March 16, 2009
Last Updated
March 16, 2009
Sponsor
Institute for Research & Development Sri Lanka
Collaborators
Institute of Psychiatry, London
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1. Study Identification

Unique Protocol Identification Number
NCT00862732
Brief Title
Study to Prevent Negative Thoughts of Life
Official Title
A Randomised Controlled Trial With Cognitive Behavioural Therapy for Persons With Active Suicidal Ideations
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
November 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Institute for Research & Development Sri Lanka
Collaborators
Institute of Psychiatry, London

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Suicidal Ideations
Keywords
active suicidal ideation, cognitive behavioural therapy, Sri Lanka, RCT

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 Cognitive Behavioural Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2 Treatment as usual
Arm Type
Active Comparator
Arm Description
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
Behavioral
Intervention Name(s)
Cognitive behavioural therapy
Intervention Description
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
Other
Intervention Name(s)
Treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of active suicidal ideations during the follow-up period
Time Frame
three months after the cessation of intervention
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sudath Samaraweera, MBBS MSc MD
Phone
+94777903407
Email
sudath.samara@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudath Samaraweera, MBBS MSc MD
Organizational Affiliation
Institute for Research & Development Sri Lanka
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Research & Development
City
Battaramulla
Country
Sri Lanka

12. IPD Sharing Statement

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Study to Prevent Negative Thoughts of Life

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