Suicidal IdeationNCT02096432
Suicide Prevention in Chinese Older Adults
A study testing Behavior Activation and Usual Community Care in people with Suicidal Ideation, run by Rush University Medical Center at 1 site in United States.
Trial summary
This project aims to develop and refine a suicide intervention protocol, and pilot test a culturally tailored randomized control trial to reduce suicidal thoughts among U.S. Chinese older adults. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Behavior Activation and Usual Community Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified as Chinese
- >50 years of age
- Suicidal thoughts within the last month as detected from the Item 9 in PHQ-9
- No plans to move for 6 months
- No significant cognitive impairment with Chinese Mini-Mental State Examination (C-MMSE) score >20
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to develop and refine a suicide intervention protocol, and pilot test a culturally tailored randomized control trial to reduce suicidal thoughts among U.S. Chinese older adults. During the first phase of the study, the investigators plan to invite the community advisory board and key stakeholders to participate in the iterative design and refinement of the study protocol. During the second phase of the project and after the initial screening and based on a specific set of inclusion criteria, the investigators will invite U.S. Chinese older adult to participate in a pilot randomized control trial of a culturally adapted intervention to reduce the frequency and intensity of suicidal thoughts in Chinese older adults. During the third phase of the project, the investigators plan to invite pilot intervention participants as well as key stakeholders and health care professionals on the cultural acceptability of the pilot intervention. Through the achievement of these objectives, the investigators will set the foundation to fully test a culturally adapted in-home intervention, which may be particularly suitable for Chinese older adults with suicidal thoughts as it addresses cultural-specific barriers and integrates care management within existing community services agencies using non-mental health professionals, including community health workers.
- Conditions
- Suicidal Ideation
- Being tested
- Behavior Activation, Usual Community Care
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior ActivationBehavioural
Behavioral Activation includes the following components: empowering education, referral to treatment, care Management, and behavior activation
Usual Community CareBehavioural
Community standard care as usual
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Behavioral Activation | Experimental | Behavioral Activation includes the following components: empowering education, referral to treatment, care Management, and behavior activation Receives: Behavioral: Behavior Activation |
| Usual Community Care | Other | Community standard care as usual Receives: Behavioral: Usual Community Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
Measured: Outcome measure will be measured in 10 weeks' time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- XinQi Dong, MD, MPH, Principal investigator, Rush University Medical CenterMelissa A. Simon, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096432
- Sponsor's protocol ID
- 13110601
- Other IDs
- R34MH100443
- Status last verified
- Dec 2022
- First submitted
- 19 Mar 2014
- Last updated
- 21 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicide Prevention in Chinese Older Adults
- ClinicalTrials.gov ID
- NCT02096432
- Acronym / sponsor ID
- 13110601
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Northwestern University, National Institute of Mental Health (NIMH)
- Study start
- Oct 2014
- Primary completion
- Jul 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to develop and refine a suicide intervention protocol, and pilot test a culturally tailored randomized control trial to reduce suicidal thoughts among U.S. Chinese older adults. During the first phase of the study, the investigators plan to invite the community advisory board and key stakeholders to participate in the iterative design and refinement of the study protocol. During the second phase of the project and after the initial screening and based on a specific set of inclusion criteria, the investigators will invite U.S. Chinese older adult to participate in a pilot randomized control trial of a culturally adapted intervention to reduce the frequency and intensity of suicidal thoughts in Chinese older adults. During the third phase of the project, the investigators plan to invite pilot intervention participants as well as key stakeholders and health care professionals on the cultural acceptability of the pilot intervention. Through the achievement of these objectives, the investigators will set the foundation to fully test a culturally adapted in-home intervention, which may be particularly suitable for Chinese older adults with suicidal thoughts as it addresses cultural-specific barriers and integrates care management within existing community services agencies using non-mental health professionals, including community health workers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Behavioral Activation | Experimental | Behavioral: Behavior ActivationBehavioral Activation includes the following components: empowering education, referral to treatment, care Management, and behavior activation |
| Usual Community Care | Other | Behavioral: Usual Community CareCommunity standard care as usual |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-identified as Chinese
- >50 years of age
- Suicidal thoughts within the last month as detected from the Item 9 in PHQ-9
- No plans to move for 6 months
- No significant cognitive impairment with Chinese Mini-Mental State Examination (C-MMSE) score >20
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior ActivationBehavioral Activation includes the following components: empowering education, referral to treatment, care Management, and behavior activation | Behavioural | Behavioral: Behavioral Activation |
| Usual Community CareCommunity standard care as usual | Behavioural | Usual Community Care |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Outcome measure will be measured in 10 weeks' time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XinQi Dong, MD, MPH principal investigator
Rush University Medical Center
Melissa A. Simon, MD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior Activation and Usual Community Care in people with Suicidal Ideation, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Outcome measure will be measured in 10 weeks' time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.