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Completed

NCT Number: NCT00736918

RCT of Post-Suicide Attempt Case Management (ACTION-J)

This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts

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Key information

Conditions

Suicide Attempt Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Suicide, Attempted

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fujita Health University Hospital, Toyoake, Aichi-ken, Japan

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About this study

It is well known that many subjects who survived a suicide attempt will make further suicide attempts, even after the medical treatment at critical emergency unit. To examine the effectiveness of continuous follow-up care by case manager after the suicide attempt, a randomized, controlled, multicenter trial by J-MISP (Japanese Multimodal Intervention Trials).This research project is one of the strategic research projects funded by The Japanese Ministry of Health, Labor and Welfare. In this study, J-MISP will implement the intervention for suicide attempters, a considerably high-risk group of further suicide attempts, who are transported by emergency services.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 20 years old
  • Suffering from Axis I disorder
  • Had intent for suicide (confirmed more than 2 times)
  • Able to understand this study and provide informed consent
  • Able to have interview before trial registry and psycho education at hospital
  • Able to have interview for assessment at continuous follow-up care by case manager at the hospital

Exclusion criteria

  • Not suffering from Axis I disorder as a primary diagnosis

Treatment and study plan

Case Management

Behavioral

Case management, Usual clinical practice and Providing paper based information for suicide prevention

Enhanced usual care

Other

Usual clinical practice and Providing paper based information for suicide prevention

Primary outcomes

  1. First recurrent suicide behavior (suicide attempted and completed suicide)

    Time frame: Minimum 1.5 year

Secondary outcomes

  1. Any cause of death

    Time frame: Minimum 1.5 year

  2. Repeated recurrent incidence of suicide attempts

    Time frame: Minimum 1.5 year

  3. Utilization or personal or social resources

    Time frame: Minimum 1.5 year

  4. Number of self-injury

    Time frame: Minimum 1.5 year

  5. Health care utilization

    Time frame: Minimum 1.5 year

  6. Physical function

    Time frame: Minimum 1.5 year

  7. Beck hopeless scale

    Time frame: Minimum 1.5 year

  8. SF-36

    Time frame: Minimum 1.5 year

  9. Adverse events

    Time frame: Minimum 1.5 year

Other outcomes

  1. Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)

    Time frame: at 1 month after the randomization

  2. Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)

    Time frame: at 3 months after the randomization

  3. Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)

    Time frame: at 6 months after the randomization

  4. Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)

    Time frame: at 12 months after the randomization

  5. Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)

    Time frame: at 18 months after the randomization

Sponsors and collaborators

Lead sponsor

Japan Foundation for Neuroscience and Mental Health

Other

Collaborators

  • National Center of Neurology and Psychiatry, Japan

Registry information

Official study title

A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)

Acronym: ACTION-J

Important dates

Study start
2006
Primary completion
2011
Study completion
2013
First posted
Aug 18, 2008
Registry last updated
Jan 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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