Suicide, AttemptedNCT05018897
Strategic Disclosure Intervention for Suicide Attempt Survivors
A study testing To Share or Not to Share and Peer Support in people with Suicide, Attempted and Mood Disorders, run by Illinois Institute of Technology at 1 site in United States.
Trial summary
While suicide prevention depends on people disclosing suicidal thoughts and behaviors in order to get help, those who talk about their suicidality also face negative responses from the people who they tell. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted, Mood Disorders
- What is being tested?
- To Share or Not to Share and Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to Aug 2022
- 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 or older
- self-reported diagnosis of mood disorder
- At least one lifetime suicide attempt
Who cannot join
- a self-reported suicide attempt within the last 3 months
- do have concerns about disclosure/ not willing to participate in program
- do not have email address
- do not have technical capability to connect to virtual platform
- cannot speak or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Illinois Institute of Technology
Chicago, Illinois, 60616
About this study
Official title: Randomized Controlled Trial of a Strategic Disclosure Intervention for Suicide Attempt Survivors
While suicide prevention depends on people disclosing suicidal thoughts and behaviors in order to get help, those who talk about their suicidality also face negative responses from the people who they tell. The investigators will conduct a randomized controlled trial of a peer-led strategic disclosure intervention for suicide attempt survivors (The To Share or Not to Share Program; called 2Share). This study evaluates the impact of the intervention on suicidal thoughts and behaviors, depression, stigma, disclosure behaviors, and psychosocial outcomes.
Read the detailed description
The estimated 1.3 million Americans who survive a suicide attempt suicide each year are at risk for ongoing suicide ideation, repeated suicide attempts, and ultimately dying by suicide. While suicide prevention often depends on people openly discussing suicidal thoughts and behaviors in order to get help for themselves or others, those who talk about their suicidality often face negative reactions from confidants. Stigmatizing responses in the form of stereotypes, prejudice, and discrimination may exacerbate symptoms and interfere with social relationships, employment opportunities, and help seeking. Feelings of shame and rejection are common experiences of suicide attempt survivors and the mere anticipation of rejection can encourage attempt survivors to maintain their silence.
Research suggests that suicide disclosure could help suicide attempt survivors in attaining needed care, expanding social support networks, strengthening relationships, and advancing coping strategies. However, few interventions are available to assist suicide attempt survivors in making critical disclosure decisions.
A peer-led strategic disclosure intervention (The 2Share Program), developed through a collaborative process with suicide attempt survivors, aids participants in: (a) evaluating the benefits and risks of disclosure; (b) considering ways to disclose; and (c) developing disclosure scripts. A pilot randomized controlled trial (RCT) with community-dwelling attempt survivors (n=38) found that intervention participants had significantly decreased depression and internalized stigma, and increased self-esteem as compared with the control group. However, this study was small and did not evaluate changes in suicidal thoughts and behaviors, help-seeking, or disclosure outcomes. The methodology was also limited in measuring longer term outcomes.
Given limitations of past research, the investigators propose a randomized controlled trial of the 2Share strategic disclosure program for community-dwelling suicide attempt survivors. The primary goal of this study is to evaluate the impact of the intervention on suicidal thoughts and behaviors and depression. Secondary goals are to examine intervention impact on stigma, disclosure, and psychosocial outcomes. A final goal of the project is to qualitatively examine participant experiences with disclosure over time.
The proposed research addresses the American Foundation for Suicide Prevention priority of determining what interventions are effective and what prevents individuals from engaging in suicidal behavior. The 2Share intervention is the first to address strategic disclosure in suicide attempt survivors, and this study will provide important data about disclosure that can ultimately aid in understanding suicide prevention.
- Conditions
- Suicide, Attempted, Mood Disorders
- Being tested
- To Share or Not to Share, Peer Support
- Keywords
- peer intervention, virtual intervention, suicide, disclosure
- Medical subject headings
- Suicide, Attempted, Mood Disorders, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To Share or Not to ShareBehavioural
Strategic disclosure intervention to help participants evaluate the pros and cons of disclosing suicidality and provide guidance on best way to disclose to get needs met. Six one-hour virtual sessions conducted weekly.
Peer SupportBehavioural
Peer-led support group for mood disorders. Six one-hour virtual sessions conducted weekly.
| Study group | Role | What they receive |
|---|---|---|
| To Share or Not to Share | Experimental | Manualized, peer-led, strategic disclosure program to guide participants in disclosing suicidality, held in group format, consisting of six sessions, each one hour in duration, once per week.
Pre-survey, post-survey, and 3-month follow-up survey Receives: Behavioral: To Share or Not to Share |
| Peer Support | Active comparator | Peer-led support group, held in group format, consisting of six sessions, each one hour in duration, once per week.
Pre-survey, post-survey, and 3-month follow-up survey Receives: Behavioral: Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in suicidality on the 9-item Suicidal Ideation Attributes Scale (SIDAS) at Week 6 and Week 19
The SIDAS is a validated, self-reported instrument assessing suicidality over the past month. Possible item scores range from 0 (no thoughts) to 10 (always) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)
Measured: Baseline, Week 6, Week 19
Change from Baseline in depression on the 10- item Center for Epidemiologic Studies Depression Scale (CESD-10) at Week 6 and Week 19
he CESD-10 is a validated, self-reported instrument assessing depression over the past week. Possible item scores range from 1 (rarely to none of the time) to 4 (most or all of the time)
Measured: Baseline, Week 6, Week 19
Secondary outcomes (9)
Change from Baseline in internalized stigma on the 9- item Internalized Stigma of Suicide (ISSA) at Week 6 and Week 19
The ISSA is a validated, self-reported instrument assessing internalized stigma. Possible item scores range from 1 (strongly disagree) to 4 (strongly agree) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)
Measured: Baseline, Week 6, Week 19
Change from Baseline in stigma-related stress on the 8- item Suicide Stigma Stress Scale (4S) at Week 6 and Week 19
The 4S is a validated, self-reported instrument assessing stigma-related stress Possible item scores range from 1 (strongly disagree) to 7 (strongly agree) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)
Measured: Baseline, Week 6, Week 19
Change from Baseline in self-esteem on the 10- item Rosenberg Self-Esteem (RSE) scale at Week 6 and Week 19
The RSE is a validated, self-reported instrument assessing self-esteem. Possible item scores range from 1 (strongly disagree) to 5 (strongly agree) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)
Measured: Baseline, Week 6, Week 19
Change from Baseline in disclosure self-efficacy on the 2- item Disclosure Self-Efficacy (DSE) scale at Week 6 and Week 19
The DSE is a validated, self-reported instrument assessing self-efficacy in disclosing suicidality. Possible item scores range from 1 (not at all) to 7 (very much) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)
Measured: Baseline, Week 6, Week 19
Change from Baseline in secrecy on the 14- item Self-Harm and Suicide Disclosure Scale (SHSDS) at Week 6 and Week 19
The SHSDS scale is a validated, self-reported instrument assessing disclosure of suicidality. Items are answered yes/no and focus on disclosure of particular ideations and behaviors.
Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)
Measured: Baseline, Week 6, Week 19
Change from Baseline in secrecy on the 5- item Secrecy scale at Week 6 and Week 19
The Secrecy scale is a validated, self-reported instrument assessing secrecy in disclosing suicidality. Possible item scores range from 1 (strongly disagree) to 7 (strongly agree) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)
Measured: Baseline, Week 6, Week 19
Change from Baseline in mental health seeking on the 3- item Mental Health Seeking Intention scale (MHSIS) at Week 6 and Week 19
The MHSIS is a validated, self-reported instrument assessing intention to seek help. Possible item scores range from 1 (extremely unlikely) to 7 (extremely likely) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)
Measured: Baseline, Week 6, Week 19
Change from Baseline in quality of life on the 1- item quality of life scale at Week 6 and Week 19
The question asks participants to rate their quality of life. Possible scores range from 1 (very poor) to 5 (very good) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)
Measured: Baseline, Week 6, Week 19
Change from Baseline in social support on the 8- item social support scale at Week 6 and Week 19
The Social Support scale is the emotional subscale from the NIH Toolbox for Social Relationships and is a validated, self-reported instrument assessing social support. Possible item scores range from 1 (never) to 5 (always) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)
Measured: Baseline, Week 6, Week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Mar 2021
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two comparison groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Illinois Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Depression and Bipolar Support Alliance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018897
- Sponsor's protocol ID
- YIG-1-151-19
- Status last verified
- Aug 2022
- First submitted
- 1 Jun 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be available through the National Institute of Mental Health (NIMH) Data Archive and through the project website at the National Consortium on Stigma and Empowerment (NCSE). No identifying information will be connected to the data and we do not believe that there is a possibility of deductive disclosure of subjects with unusual characteristics. We will certify the quality of all data prior to submission to New Drugs and Clinical Trials (NDCT). Descriptive/raw data will be submitted semi-annually (prior to January 15 and July 15) and will be checked for quality within four months. All other data will be submitted at the time of publication, or prior to the end of the grant, whichever occurs first. The final de-identified dataset and codebook will be posted on NCSE website at the time of publication. We will share results, positive and negative, specific to the cohorts and outcome measures studied by using the Study functionality.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Strategic Disclosure Intervention for Suicide Attempt Survivors
- ClinicalTrials.gov ID
- NCT05018897
- Acronym / sponsor ID
- YIG-1-151-19
- Conditions
- Suicide, Attempted, Mood Disorders
- Keywords
- peer intervention, virtual intervention, suicide, disclosure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Illinois Institute of TechnologyUniversity, hospital or other
- Collaborators
- Depression and Bipolar Support Alliance
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 24 Aug 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.
While suicide prevention depends on people disclosing suicidal thoughts and behaviors in order to get help, those who talk about their suicidality also face negative responses from the people who they tell. The investigators will conduct a randomized controlled trial of a peer-led strategic disclosure intervention for suicide attempt survivors (The To Share or Not to Share Program; called 2Share). This study evaluates the impact of the intervention on suicidal thoughts and behaviors, depression, stigma, disclosure behaviors, and psychosocial outcomes.
Detailed description
The estimated 1.3 million Americans who survive a suicide attempt suicide each year are at risk for ongoing suicide ideation, repeated suicide attempts, and ultimately dying by suicide. While suicide prevention often depends on people openly discussing suicidal thoughts and behaviors in order to get help for themselves or others, those who talk about their suicidality often face negative reactions from confidants. Stigmatizing responses in the form of stereotypes, prejudice, and discrimination may exacerbate symptoms and interfere with social relationships, employment opportunities, and help seeking. Feelings of shame and rejection are common experiences of suicide attempt survivors and the mere anticipation of rejection can encourage attempt survivors to maintain their silence.
Research suggests that suicide disclosure could help suicide attempt survivors in attaining needed care, expanding social support networks, strengthening relationships, and advancing coping strategies. However, few interventions are available to assist suicide attempt survivors in making critical disclosure decisions.
A peer-led strategic disclosure intervention (The 2Share Program), developed through a collaborative process with suicide attempt survivors, aids participants in: (a) evaluating the benefits and risks of disclosure; (b) considering ways to disclose; and (c) developing disclosure scripts. A pilot randomized controlled trial (RCT) with community-dwelling attempt survivors (n=38) found that intervention participants had significantly decreased depression and internalized stigma, and increased self-esteem as compared with the control group. However, this study was small and did not evaluate changes in suicidal thoughts and behaviors, help-seeking, or disclosure outcomes. The methodology was also limited in measuring longer term outcomes.
Given limitations of past research, the investigators propose a randomized controlled trial of the 2Share strategic disclosure program for community-dwelling suicide attempt survivors. The primary goal of this study is to evaluate the impact of the intervention on suicidal thoughts and behaviors and depression. Secondary goals are to examine intervention impact on stigma, disclosure, and psychosocial outcomes. A final goal of the project is to qualitatively examine participant experiences with disclosure over time.
The proposed research addresses the American Foundation for Suicide Prevention priority of determining what interventions are effective and what prevents individuals from engaging in suicidal behavior. The 2Share intervention is the first to address strategic disclosure in suicide attempt survivors, and this study will provide important data about disclosure that can ultimately aid in understanding suicide prevention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two comparison groups
| Arm | Type | Receives |
|---|---|---|
| To Share or Not to Share | Experimental | Behavioral: To Share or Not to ShareManualized, peer-led, strategic disclosure program to guide participants in disclosing suicidality, held in group format, consisting of six sessions, each one hour in duration, once per week. Pre-survey, post-survey, and 3-month follow-up survey |
| Peer Support | Active comparator | Behavioral: Peer SupportPeer-led support group, held in group format, consisting of six sessions, each one hour in duration, once per week. Pre-survey, post-survey, and 3-month follow-up survey |
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 or older
- self-reported diagnosis of mood disorder
- At least one lifetime suicide attempt
Key exclusion criteria (5 listed)
- a self-reported suicide attempt within the last 3 months
- do have concerns about disclosure/ not willing to participate in program
- do not have email address
- do not have technical capability to connect to virtual platform
- cannot speak or read English
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 |
|---|---|---|
| To Share or Not to ShareStrategic disclosure intervention to help participants evaluate the pros and cons of disclosing suicidality and provide guidance on best way to disclose to get needs met. Six one-hour virtual sessions conducted weekly. | Behavioural | To Share or Not to Share |
| Peer SupportPeer-led support group for mood disorders. Six one-hour virtual sessions conducted weekly. | Behavioural | Peer Support |
Primary outcome
Change from Baseline in suicidality on the 9-item Suicidal Ideation Attributes Scale (SIDAS) at Week 6 and Week 19
Time frame: Baseline, Week 6, Week 19
The SIDAS is a validated, self-reported instrument assessing suicidality over the past month. Possible item scores range from 0 (no thoughts) to 10 (always) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)
Change from Baseline in depression on the 10- item Center for Epidemiologic Studies Depression Scale (CESD-10) at Week 6 and Week 19
Time frame: Baseline, Week 6, Week 19
he CESD-10 is a validated, self-reported instrument assessing depression over the past week. Possible item scores range from 1 (rarely to none of the time) to 4 (most or all of the time)
9 secondary outcomes
Change from Baseline in internalized stigma on the 9- item Internalized Stigma of Suicide (ISSA) at Week 6 and Week 19
Time frame: Baseline, Week 6, Week 19
Change from Baseline in stigma-related stress on the 8- item Suicide Stigma Stress Scale (4S) at Week 6 and Week 19
Time frame: Baseline, Week 6, Week 19
Change from Baseline in self-esteem on the 10- item Rosenberg Self-Esteem (RSE) scale at Week 6 and Week 19
Time frame: Baseline, Week 6, Week 19
Change from Baseline in disclosure self-efficacy on the 2- item Disclosure Self-Efficacy (DSE) scale at Week 6 and Week 19
Time frame: Baseline, Week 6, Week 19
Change from Baseline in secrecy on the 14- item Self-Harm and Suicide Disclosure Scale (SHSDS) at Week 6 and Week 19
Time frame: Baseline, Week 6, Week 19
Change from Baseline in secrecy on the 5- item Secrecy scale at Week 6 and Week 19
Time frame: Baseline, Week 6, Week 19
Change from Baseline in mental health seeking on the 3- item Mental Health Seeking Intention scale (MHSIS) at Week 6 and Week 19
Time frame: Baseline, Week 6, Week 19
Change from Baseline in quality of life on the 1- item quality of life scale at Week 6 and Week 19
Time frame: Baseline, Week 6, Week 19
Change from Baseline in social support on the 8- item social support scale at Week 6 and Week 19
Time frame: Baseline, Week 6, Week 19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: Yes. Results will be available through the National Institute of Mental Health (NIMH) Data Archive and through the project website at the National Consortium on Stigma and Empowerment (NCSE). No identifying information will be connected to the data and we do not believe that there is a possibility of deductive disclosure of subjects with unusual characteristics. We will certify the quality of all data prior to submission to New Drugs and Clinical Trials (NDCT). Descriptive/raw data will be submitted semi-annually (prior to January 15 and July 15) and will be checked for quality within four months. All other data will be submitted at the time of publication, or prior to the end of the grant, whichever occurs first. The final de-identified dataset and codebook will be posted on NCSE website at the time of publication. We will share results, positive and negative, specific to the cohorts and outcome measures studied by using the Study functionality.
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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 To Share or Not to Share and Peer Support in people with Suicide, Attempted and Mood Disorders, run by Illinois Institute of Technology 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 5 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: status not confirmed, as of the sponsor's last update on 10 Aug 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?
Results are not available in the source record.
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 from Baseline in suicidality on the 9-item Suicidal Ideation Attributes Scale (SIDAS) at Week 6 and Week 19 (time frame: Baseline, Week 6, Week 19). The study lists 2 primary outcomes in all. 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 10 Aug 2022.