UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019293 |
|---|---|
| Receipt number | 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 13:21:28 |
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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
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
esensei@yahoo.com
Sponsor or person
Institute
James Cook University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022314
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