Strategic Disclosure Intervention for Suicide Attempt Survivors
Primary Purpose
Suicide, Attempted, Mood Disorders
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
To Share or Not to Share
Peer Support
Sponsored by
About this trial
This is an interventional health services research trial for Suicide, Attempted focused on measuring peer intervention, virtual intervention, suicide, disclosure
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- self-reported diagnosis of mood disorder
- At least one lifetime suicide attempt
Exclusion Criteria:
- 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
Sites / Locations
- Illinois Institute of Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
To Share or Not to Share
Peer Support
Arm Description
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
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
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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)
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)
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)
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)
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)
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)
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)
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)
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)
Full Information
NCT ID
NCT05018897
First Posted
June 1, 2021
Last Updated
August 9, 2022
Sponsor
Illinois Institute of Technology
Collaborators
Depression and Bipolar Support Alliance
1. Study Identification
Unique Protocol Identification Number
NCT05018897
Brief Title
Strategic Disclosure Intervention for Suicide Attempt Survivors
Official Title
Randomized Controlled Trial of a Strategic Disclosure Intervention for Suicide Attempt Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Illinois Institute of Technology
Collaborators
Depression and Bipolar Support Alliance
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Mood Disorders
Keywords
peer intervention, virtual intervention, suicide, disclosure
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with two comparison groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
To Share or Not to Share
Arm Type
Experimental
Arm Description
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
Arm Title
Peer Support
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
To Share or Not to Share
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Support
Intervention Description
Peer-led support group for mood disorders. Six one-hour virtual sessions conducted weekly.
Primary Outcome Measure Information:
Title
Change from Baseline in suicidality on the 9-item Suicidal Ideation Attributes Scale (SIDAS) at Week 6 and Week 19
Description
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)
Time Frame
Baseline, Week 6, Week 19
Title
Change from Baseline in depression on the 10- item Center for Epidemiologic Studies Depression Scale (CESD-10) at Week 6 and Week 19
Description
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)
Time Frame
Baseline, Week 6, Week 19
Secondary Outcome Measure Information:
Title
Change from Baseline in internalized stigma on the 9- item Internalized Stigma of Suicide (ISSA) at Week 6 and Week 19
Description
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)
Time Frame
Baseline, Week 6, Week 19
Title
Change from Baseline in stigma-related stress on the 8- item Suicide Stigma Stress Scale (4S) at Week 6 and Week 19
Description
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)
Time Frame
Baseline, Week 6, Week 19
Title
Change from Baseline in self-esteem on the 10- item Rosenberg Self-Esteem (RSE) scale at Week 6 and Week 19
Description
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)
Time Frame
Baseline, Week 6, Week 19
Title
Change from Baseline in disclosure self-efficacy on the 2- item Disclosure Self-Efficacy (DSE) scale at Week 6 and Week 19
Description
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)
Time Frame
Baseline, Week 6, Week 19
Title
Change from Baseline in secrecy on the 14- item Self-Harm and Suicide Disclosure Scale (SHSDS) at Week 6 and Week 19
Description
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)
Time Frame
Baseline, Week 6, Week 19
Title
Change from Baseline in secrecy on the 5- item Secrecy scale at Week 6 and Week 19
Description
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)
Time Frame
Baseline, Week 6, Week 19
Title
Change from Baseline in mental health seeking on the 3- item Mental Health Seeking Intention scale (MHSIS) at Week 6 and Week 19
Description
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)
Time Frame
Baseline, Week 6, Week 19
Title
Change from Baseline in quality of life on the 1- item quality of life scale at Week 6 and Week 19
Description
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)
Time Frame
Baseline, Week 6, Week 19
Title
Change from Baseline in social support on the 8- item social support scale at Week 6 and Week 19
Description
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)
Time Frame
Baseline, Week 6, Week 19
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
self-reported diagnosis of mood disorder
At least one lifetime suicide attempt
Exclusion Criteria:
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
Facility Information:
Facility Name
Illinois Institute of Technology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The final de-identified dataset and codebook will be shared at the time of publication.
Learn more about this trial
Strategic Disclosure Intervention for Suicide Attempt Survivors
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