Study to Prevent Negative Thoughts of Life

Study Overview
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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

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

Conditions
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Active Suicidal Ideations

Intervention / Treatment
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* Behavioral: Cognitive behavioural therapy
* Other: Treatment as usual


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Cognitive Behavioural Therapy<br>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<br>* 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.<br>|
| Active Comparator: 2 Treatment as usual<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | three months after the cessation of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, active suicidal ideation, cognitive behavioural therapy, Sri Lanka