Strategic Disclosure Intervention for Suicide Attempt Survivors

NCT05018897 | Unknown DMC

• 1 other identifier: YIG-1-151-19
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide, Attempted; Mood Disorders

Keywords

peer intervention; virtual intervention; suicide; disclosure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change from Baseline in internalized stigma on the 9- item Internalized Stigma of Suicide (ISSA) at Week 6 and Week 19

  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

  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

  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

  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

  Baseline, Week 6, Week 19

Study Arms (2)

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

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

Behavioral: Peer Support

Interventions

To Share or Not to Share BEHAVIORAL

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.

To Share or Not to Share

Peer Support BEHAVIORAL

Peer-led support group for mood disorders. Six one-hour virtual sessions conducted weekly.

Peer Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• self-reported diagnosis of mood disorder
• At least one lifetime suicide attempt

You may not qualify if:

• 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

Sponsors & Collaborators

• Illinois Institute of Technology: lead
• Depression and Bipolar Support Alliance: collaborator

Study Sites (1)

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Suicide, Attempted; Mood Disorders; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two comparison groups

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: August 24, 2021
• Study Start: March 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: The final de-identified dataset and codebook will be shared at the time of publication.

Locations

US (1)