Clinical trial NCT05018897: Strategic Disclosure Intervention for Suicide Attempt Survivors
Official title: Randomized Controlled Trial of a Strategic Disclosure Intervention for Suicide Attempt Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide, Attempted
Mood Disorders
Keywords: peer intervention
virtual intervention
suicide
disclosure
Lead sponsor: Illinois Institute of Technology
Sponsor class: OTHER
Collaborators: name: Depression and Bipolar Support Alliance
First posted: 2021-08-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two comparison groups
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change from Baseline in suicidality on the 9-item Suicidal Ideation Attributes Scale (SIDAS) at Week 6 and Week 19
timeFrame: Baseline, Week 6, Week 19
measure: Change from Baseline in depression on the 10- item Center for Epidemiologic Studies Depression Scale (CESD-10) at Week 6 and Week 19
timeFrame: Baseline, Week 6, Week 19
Secondary outcomes:
measure: Change from Baseline in internalized stigma on the 9- item Internalized Stigma of Suicide (ISSA) at Week 6 and Week 19
timeFrame: Baseline, Week 6, Week 19
measure: Change from Baseline in stigma-related stress on the 8- item Suicide Stigma Stress Scale (4S) at Week 6 and Week 19
timeFrame: Baseline, Week 6, Week 19
measure: Change from Baseline in self-esteem on the 10- item Rosenberg Self-Esteem (RSE) scale at Week 6 and Week 19
timeFrame: Baseline, Week 6, Week 19
measure: Change from Baseline in disclosure self-efficacy on the 2- item Disclosure Self-Efficacy (DSE) scale at Week 6 and Week 19
timeFrame: Baseline, Week 6, Week 19
measure: Change from Baseline in secrecy on the 14- item Self-Harm and Suicide Disclosure Scale (SHSDS) at Week 6 and Week 19
timeFrame: Baseline, Week 6, Week 19
measure: Change from Baseline in secrecy on the 5- item Secrecy scale at Week 6 and Week 19
timeFrame: Baseline, Week 6, Week 19
measure: Change from Baseline in mental health seeking on the 3- item Mental Health Seeking Intention scale (MHSIS) at Week 6 and Week 19
timeFrame: Baseline, Week 6, Week 19
measure: Change from Baseline in quality of life on the 1- item quality of life scale at Week 6 and Week 19
timeFrame: Baseline, Week 6, Week 19
measure: Change from Baseline in social support on the 8- item social support scale at Week 6 and Week 19
timeFrame: Baseline, Week 6, Week 19
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Illinois Institute of Technology
state: Illinois
Study officials:
References: