Suicide, AttemptedNCT04903431
Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for Suicide Risk
A study testing Crisis Response Planning for Suicide Risk in people with Suicide, Attempted and Suicidal Ideation, run by Ohio State University at 1 site in United States.
Trial summary
The aim of the current project is to compare the use and preliminary effectiveness of a self-administered version of the Crisis Response Plan (CRP) in decreasing suicidal/death ideation and distress and increasing positive affect when compared to a clinician-administered version of the protocol in a sample of 150… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation
- What is being tested?
- Crisis Response Planning for Suicide Risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 21 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- US military veteran
- death or suicidal ideation/suicide attempt within the past month
Who cannot join
- non-Veteran status
- acute intoxication or active psychosis precluding provision of informed consent
- inability to communicate and comprehend English
- residence outside the United States
- lack of past-month death/suicide ideation or attempt
- lack of device connected to webcam or internet
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current project is to compare the use and preliminary effectiveness of a self-administered version of the Crisis Response Plan (CRP) in decreasing suicidal/death ideation and distress and increasing positive affect when compared to a clinician-administered version of the protocol in a sample of 150 military Veterans experiencing current death or suicidal ideation.
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Being tested
- Crisis Response Planning for Suicide Risk
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisis Response Planning for Suicide RiskBehavioural
Crisis Response Planning is focused on creating personalized set of steps for individuals to follow in case of a crisis and includes individuals' personal warning signs of distress, behavioral coping strategies, reasons for living, social supports to contact, and contact information for professional services, including emergency services. Personalization of the Crisis Response Plan is encouraged, and individuals are instructed to handwrite each step of the Crisis Response Plan on an index card to review.
| Study group | Role | What they receive |
|---|---|---|
| Clinician-administered Crisis Response Plan | Active comparator | Clinicians will administer the Crisis Response Plan to 75 military veterans. Receives: Behavioral: Crisis Response Planning for Suicide Risk |
| Self-administered Crisis Response Plan | Experimental | Participants will complete a self-guided version of the Crisis Response plan online. Receives: Behavioral: Crisis Response Planning for Suicide Risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Suicide Visual Analog Scale scores from the previous daily assessment
The Suicide Visual Analog Scale The S-VAS assesses "urge to kill myself" using a horizontal line with anchors on the left reflecting "none" (score: 0) and on the right reflecting "extreme" (score: 100). The S-VAS is initially presented with the indicator on the "none" position, and non-movement of the indicator is followed by a prompt to remind the participant to move the indicator, if relevant, to ensure response accuracy. Higher scores are indicative of greater severity
Measured: Administered daily for eight consecutive days
Secondary outcomes (3)
Change in Patient Health Questionnaire - 2 scores from the previous daily assessment
The PHQ-2 is a 2-item measure of depression symptom severity adapted from the 9-item version of the PHQ (Kroenke \& Spitzer, 2002). Item responses are scores on a Likert scale ranging from 0 to 3. Total scores range from 0 to 6, with higher scores indicating greater symptom severity.
Measured: Administered daily for eight consecutive days
Change in Positive and Negative Affect Schedule - Short Form scores from the previous daily assessment
The Positive and Negative Affect Schedule - Short Form a 20-item validated self-report measure of state positive and negative affect. The measure contains two, 10-item subscales measuring positive and negative affect, respectively. Possible total scores for each subscale range from 10 to 50, with higher scores indicating greater state affect.
Measured: Administered daily for eight consecutive days
Change in Crisis Response Plan Use from the previous daily assessment
- In order to assess whether CRP use after completion impacts suicide urges and affect, participants will be instructed to "Please list all dates and times that you used part or all of the Crisis Response Plan that you completed since you last completed this survey. (or since you completed your Crisis Response Plan if this is the first survey you will complete)" You may provide us with your best estimates of dates and times."
Measured: Administered daily for eight consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start15 Dec 2021
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Khazem, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903431
- Sponsor's protocol ID
- 2020B0414-B
- Status last verified
- Oct 2023
- First submitted
- 18 May 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for Suicide Risk
- ClinicalTrials.gov ID
- NCT04903431
- Acronym / sponsor ID
- 2020B0414-B
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 26 May 2021 (actual)
- 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.
The aim of the current project is to compare the use and preliminary effectiveness of a self-administered version of the Crisis Response Plan (CRP) in decreasing suicidal/death ideation and distress and increasing positive affect when compared to a clinician-administered version of the protocol in a sample of 150 military Veterans experiencing current death or suicidal ideation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinician-administered Crisis Response Plan | Active comparator | Behavioral: Crisis Response Planning for Suicide RiskClinicians will administer the Crisis Response Plan to 75 military veterans. |
| Self-administered Crisis Response Plan | Experimental | Behavioral: Crisis Response Planning for Suicide RiskParticipants will complete a self-guided version of the Crisis Response plan online. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- US military veteran
- death or suicidal ideation/suicide attempt within the past month
Key exclusion criteria (6 listed)
- non-Veteran status
- acute intoxication or active psychosis precluding provision of informed consent
- inability to communicate and comprehend English
- residence outside the United States
- lack of past-month death/suicide ideation or attempt
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 |
|---|---|---|
| Crisis Response Planning for Suicide RiskCrisis Response Planning is focused on creating personalized set of steps for individuals to follow in case of a crisis and includes individuals' personal warning signs of distress, behavioral coping strategies, reasons for living, social supports to contact, and contact information for professional services, including emergency services. Personalization of the Crisis Response Plan is encouraged, and individuals are instructed to handwrite each step of the Crisis Response Plan on an index card to review. | Behavioural | Clinician-administered Crisis Response Plan, Self-administered Crisis Response Plan |
Primary outcome
Change in Suicide Visual Analog Scale scores from the previous daily assessment
Time frame: Administered daily for eight consecutive days
The Suicide Visual Analog Scale The S-VAS assesses "urge to kill myself" using a horizontal line with anchors on the left reflecting "none" (score: 0) and on the right reflecting "extreme" (score: 100). The S-VAS is initially presented with the indicator on the "none" position, and non-movement of the indicator is followed by a prompt to remind the participant to move the indicator, if relevant, to ensure response accuracy. Higher scores are indicative of greater severity
3 secondary outcomes
Change in Patient Health Questionnaire - 2 scores from the previous daily assessment
Time frame: Administered daily for eight consecutive days
Change in Positive and Negative Affect Schedule - Short Form scores from the previous daily assessment
Time frame: Administered daily for eight consecutive days
Change in Crisis Response Plan Use from the previous daily assessment
Time frame: Administered daily for eight consecutive days
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 5 Oct 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crisis Response Planning for Suicide Risk in people with Suicide, Attempted and Suicidal Ideation, run by Ohio State University 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 3 inclusion and 6 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 5 Oct 2023. 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?
Change in Suicide Visual Analog Scale scores from the previous daily assessment (time frame: Administered daily for eight consecutive days). 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 5 Oct 2023.