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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019293
Receipt No. R000022314
Scientific Title Is Suicide or Psychosocial Assessment Risky for Participants? Results from a Randomized Controlled Trial
Date of disclosure of the study information 2015/10/15
Last modified on 2015/10/09

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Basic information
Public title Is Suicide or Psychosocial Assessment Risky for Participants? Results from a Randomized Controlled Trial
Acronym Is Suicide or Psychosocial Assessment Risky for Participants?
Scientific Title Is Suicide or Psychosocial Assessment Risky for Participants? Results from a Randomized Controlled Trial
Scientific Title:Acronym Is Suicide or Psychosocial Assessment Risky for Participants?
Region
Asia(except Japan)

Condition
Condition There were two conditions: experimental and control. The experimental condition included a survey with suicide assessment items. The control condition included a survey without suicide items.
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A common ethical concern is for the psychological wellbeing of research participants during and after their involvement in a study. We aimed to test whether adult English-speaking survey participants, in Singapore, felt distressed if they answered questions on their suicidal thoughts and behaviors.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Outcomes were measured posttest (after the survey). Assessed by the Positive and Negative Affect Schedule.
Key secondary outcomes Semi-structured interviews collected qualitative data on participant affect and responses to the survey.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 The experimental/intervention survey included a standardized measure of suicide (Suicidal Affect-Behavior-Cognition Scale; SABCS), and other suicide items. It also included other psychosocial measures. It took approximately 20 minutes to complete.
Interventions/Control_2 The control survey did not include any suicide questions. It included a measure of quality of life. The control survey also included the same psychosocial measures as the experimental condition. It also took approximately 20 minutes to complete.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria English-speaking, not currently in psychiatric treatment.
Key exclusion criteria Under 18 years of age, in psychiatric treatment, insufficient English language ability.
Target sample size 259

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keith M. Harris
Organization University of Queensland
Division name School of Psychology
Zip code
Address Behavioral Sciences Bldg, St Lucia, Qld, 4072, Australia
TEL 610424624434
Email esensei@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name Keith Harris
Organization University of Queensland
Division name School of Psychology
Zip code
Address Behavioral Sciences Bldg, St Lucia, Qld, 4072, Australia
TEL 610424624434
Homepage URL
Email esensei@yahoo.com

Sponsor
Institute James Cook University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 H3771
Org. issuing International ID_1 James Cook University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results are nearly complete and will be submitted for publication in late 2015. 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 12 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
2011 Year 06 Month 30 Day
Date trial data considered complete
2011 Year 09 Month 01 Day
Date analysis concluded
2015 Year 10 Month 10 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 09 Day
Last modified on
2015 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022314

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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