Study to Prevent Negative Thoughts of Life

March 16, 2009 updated by: Institute for Research & Development Sri Lanka

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sri Lanka
      • Battaramulla, Sri Lanka
        • Institute for Research & Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of active suicidal ideations during the follow-up period
Time Frame: three months after the cessation of intervention
three months after the cessation of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
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
three months after the cessation of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Research & Development Sri Lanka

Collaborators

Institute of Psychiatry, London

Investigators

  • Principal Investigator: Sudath Samaraweera, MBBS MSc MD, Institute for Research & Development Sri Lanka

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ANTICIPATED)

November 1, 2009

Study Completion (ANTICIPATED)

November 1, 2009

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (ESTIMATE)

March 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2009

Last Update Submitted That Met QC Criteria

March 16, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRD/03-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Active Suicidal Ideations

Clinical Trials on Cognitive behavioural therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe