Strategic Disclosure Intervention for Suicide Attempt Survivors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mood Disorders; Suicide, Attempted
• Intervention / Treatment: Behavioral: To Share or Not to Share; Behavioral: Peer Support

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Illinois Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: To Share or Not to Share; 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	Behavioral: To Share or Not to Share; 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.
Active Comparator: Peer Support; 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	Behavioral: Peer Support; Peer-led support group for mood disorders. Six one-hour virtual sessions conducted weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Baseline, Week 6, Week 19

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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)	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)	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)	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)	Baseline, Week 6, Week 19

Collaborators and Investigators

• Sponsor: Illinois Institute of Technology
• Collaborators: Depression and Bipolar Support Alliance

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: disclosure; suicide; peer intervention; virtual intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Self-Injurious Behavior; Suicide; Suicide, Attempted; Mood Disorders
• Other Study ID Numbers: YIG-1-151-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No