Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NSC96-2314-B195-011
Study information
Scientific title
Effect of proactive psychosocial treatment by the case manager in patients after a suicide attempt: a randomised controlled trial
Acronym
Study hypothesis
Compared with usual care, intervention group will:
1. Improve treatment attendance
2. Have less repeated suicide attempts in adults after an initial suicide attempt
3. Have better satisfaction with care
Ethics approval
Approved by the Mackay Memorial Hospital Institutional Review Board in November 2006.
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Suicide attempts
Intervention
A case manager will be assigned to each of the participants in the intervention group. All case managers are psychologists. After discharge from the emergency department, the participants receive six sessions of proactive psychosocial intervention by their case manager over four months. Duration of each session is approximately 30 minutes. The intervention consists of telephone or face-to-face contacts with the case manager at scheduled intervals or when clinically necessary. If a patient declines medication therapy from the psychiatrist, case manager will provide psychotherapy using the model of cognitive-behavioural approach and problem-solving therapy. Case managers will receive backup and supervision by psychiatrist investigators and monthly supervision of therapy. Case managers will regularly monitor suicide risk, clinical status and provide follow-up.
The control group will receive "treatment as usual", which in most cases consists of consultation with an on-site social worker or a psychiatrist at the Emergency Room, provision of a self-help leaflet and referral to a psychiatrist.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Treatment adherence, defined as outpatient mental health clinic attendance at 6 and 12 month.
Secondary outcome measures
The following will be assessed during follow-up periods (6 and 12 month):
1. Number of suicide attempts (behaviour)
2. Suicidal ideation
3. Depression score
4. Patients' satisfaction with care
Overall trial start date
01/04/2008
Overall trial end date
30/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients who will be discharged from an emergency department of a teaching hospital after a suicide attempt
2. Aged above 18 years old, both men and women
3. Agree to provide written inform consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Patients who are too ill to be interviewed
2. Patients who have immediate and severe suicide risk
Recruitment start date
01/04/2008
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Taiwan
Trial participating centre
Department of Psychiatry
Taipei County
25115
Taiwan
Sponsor information
Organisation
National Science Council (Taiwan)
Sponsor details
No. 106
HoPing E Road
Sec 2
Taipei 10622
Taipei County
25115
Taiwan
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Science Council (Taiwan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list