NCT00862732

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 17, 2009

Status Verified

March 1, 2009

Enrollment Period

8 months

First QC Date

March 16, 2009

Last Update Submit

March 16, 2009

Conditions

Active Suicidal Ideations

Keywords

active suicidal ideationcognitive behavioural therapySri LankaRCT

Outcome Measures

Primary Outcomes (1)

  • Presence of active suicidal ideations during the follow-up period

    three months after the cessation of intervention

Secondary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

Cognitive behavioural therapyBEHAVIORAL

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.

1 Cognitive Behavioural Therapy
Treatment as usualOTHER

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.

2 Treatment as usual

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 - 64 years
  • Self reported current active suicidal ideations
  • Ability to speak and write Sinhala

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Research & Development

Battaramulla, Sri Lanka

Location

MeSH Terms

Interventions

Cognitive Behavioral TherapyTherapeutics

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sudath Samaraweera, MBBS MSc MD

    Institute for Research & Development Sri Lanka

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sudath Samaraweera, MBBS MSc MD

CONTACT

+94777903407sudath.samara@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

March 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 17, 2009

Record last verified: 2009-03

Locations

SR(1)