Active Suicidal IdeationsNCT00862732
Study to Prevent Negative Thoughts of Life
A study testing Cognitive behavioural therapy and Treatment as usual in people with Active Suicidal Ideations, run by Institute for Research & Development Sri Lanka at 1 site in Sri Lanka.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Active Suicidal Ideations
- What is being tested?
- Cognitive behavioural therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSri Lanka
- Study dates
- Mar 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 - 64 years
- Self reported current active suicidal ideations
- Ability to speak and write Sinhala
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Active Suicidal Ideations
- Being tested
- Cognitive behavioural therapy, Treatment as usual
- Keywords
- active suicidal ideation, cognitive behavioural therapy, Sri Lanka, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapyBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of active suicidal ideations during the follow-up period
Measured: 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
Measured: three months after the cessation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Suicidal IdeationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Research & Development Sri Lanka
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Psychiatry, London
- Investigators
- Sudath Samaraweera, MBBS MSc MD, Principal investigator, Institute for Research & Development Sri Lanka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862732
- Sponsor's protocol ID
- IRD/03-08
- Status last verified
- Mar 2009
- First submitted
- 16 Mar 2009
- Last updated
- 17 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial With Cognitive Behavioural Therapy for Persons With Active Suicidal Ideations
- ClinicalTrials.gov ID
- NCT00862732
- Acronym / sponsor ID
- IRD/03-08
- Conditions
- Active Suicidal Ideations
- Keywords
- active suicidal ideation, cognitive behavioural therapy, Sri Lanka, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Institute for Research & Development Sri LankaUniversity, hospital or other
- Collaborators
- Institute of Psychiatry, London
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 17 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Cognitive Behavioural Therapy | Active comparator | Behavioral: Cognitive behavioural therapyIntervention 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. |
| 2 Treatment as usual | Active comparator | Other: Treatment as usualWill 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 - 64 years
- Self reported current active suicidal ideations
- Ability to speak and write Sinhala
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapyWill 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. | Behavioural | 1 Cognitive Behavioural Therapy |
| Treatment as usualWill 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 | 2 Treatment as usual |
Primary outcome
Presence of active suicidal ideations during the follow-up period
Time frame: three months after the cessation of intervention
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2009.
Related trials for Active Suicidal Ideations
Not yet recruiting
Personalized TACS to Reduce Rumination in Patients with Active Suicidal Ideation
Suicidal Ideation Active, Depression Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudath Samaraweera, MBBS MSc MD principal investigator
Institute for Research & Development Sri Lanka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy and Treatment as usual in people with Active Suicidal Ideations, run by Institute for Research & Development Sri Lanka at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sudath Samaraweera, MBBS MSc MD (+94777903407, sudath.samara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of active suicidal ideations during the follow-up period (time frame: three months after the cessation of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2009; AzTrials last refreshed its copy on 3 Nov 2026.