Condition category
Mental and Behavioural Disorders
Date applied
05/04/2008
Date assigned
01/05/2008
Last edited
01/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shen-Ing Liu

ORCID ID

Contact details

Department of Psychiatry
Mackay Memorial Hospital
No 45
Ming-Shan Road
Tam-Shu
Chu-Wui
Taipei County
25115
Taiwan

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 measures

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

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

http://web.nsc.gov.tw/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes