To Share Or Not To Share

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the group-based intervention To Share Or Not To Share in a German clinical setting. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial.

Detailed Description
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People who have survived a suicide attempt often face public and self-stigma, and secrecy is a common strategy to minimize the risk of being labeled. Both secrecy and disclosure have pros and cons. The decision whether, when, and to whom to disclose a previous suicide attempt is complex. Interventions can provide guidance for systematic consideration and a well informed decision. Potentially, it may not be disclosure itself, but the empowered decision for or against disclosure of a previous suicide attempt that reduces distress and leads to beneficial outcomes. The manualized peer-led group intervention Honest, Open, Proud (HOP) supports people with mental illness in their decision whether to disclose mental illness. Research showed positive effects of the intervention on stigma stress, disclosure-related distress and quality of life. Based on HOP, To Share Or Not To Share (2Share) was developed to systematically guide suicide attempt survivors through their decision whether and how to disclose a previous suicide attempt. 2Share led to significant reductions in self-stigma and depressive symptoms, as well as increased self-esteem in a recent pilot randomized-controlled trial (RCT) in the US. The aim of the current study is to evaluate 2Share in a German clinical setting. Feasibility and efficacy of 2 Share will be tested in a pilot RCT.

Official Title
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To Share or Not To Share (2Share) - Group Intervention to Support Disclosure Decisions After Suicide Attempt

Conditions
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History of Suicide Attempt

Intervention / Treatment
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* Behavioral: 2Share


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current inpatient, outpatient or day clinical treatment at the Bezirkskrankenhaus Günzburg, Germany Age ≥ 18 years At least one previous suicide attempt Positive screening for disclosure distress (1 item: In general, how distressed or worried are you in terms of secrecy or disclosure of your suicide attempt?, self-report, persons with a score ≥ 4 on a scale from 1-7 are included) Written informed consent Sufficient German language skills Exclusion Criteria: Current suicidality (1 item: Have you had thoughts that you would be better off dead for at least several days during the last week?, self-report, persons responding with yes will be excluded and will be offered support) Suicide attempt within the last four weeks Dementia or organic disease (ICD-10: F0) Primary substance dependence (ICD-10: F1x.2)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (2Share) + treatment as usual<br>Study participants randomized to the experimental group receive the intervention (2Share) while maintaining their current treatment (treatment as usual). 2Share is a peer-led group intervention containing three two-hour sessions within two weeks plus an additional booster session four weeks later. Fidelity to manual is rated in each session by study staff. | Behavioral: 2Share<br>* The peer-led group program contains of three lessons plus one booster session: Lesson 1: Consider the pros and cons of disclosing: Participants reflect on their experience of self-stigma and weigh their pros and cons of (non-)disclosing a suicide attempt. Lesson 2: Different ways to disclose: Participants learn about the different ways to disclose and their respective pros and cons. Afterwards participants develop strategies to choose a person to disclose to, and discuss possible responses they might experience. Lesson 3: Telling your story: Participants learn how to tell their own story. In a booster session, participants will discuss their experiences with disclosure or non-disclosure.<br>|
| No Intervention: Treatment as usual<br>Participants randomized to the control group do not receive the group program but maintain their current treatment (treatment as usual). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-stigma related to suicide attempt | Self-Stigma of Suicide Attempt Survivor Scale (SSSAS), 14-item apply subscale (Sheehan et al, 2018); each item is rated from 1-9, we will calculate a sum score accross all items (range 9-126) with higher scores indicating more self-stigma. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-stigma related to suicide attempt | Self-Stigma of Suicide Attempt Survivor Scale (SSSAS), 14-item apply subscale (Sheehan et al, 2018); each item is rated from 1-9, we will calculate a sum score accross all items (range 9-126) with higher scores indicating more self-stigma. | baseline, 6 weeks, 12 weeks | 
| Self-Stigma (alienation) related to suicide attempt | Internalized Stigma of Mental Illness scale (ISMI), 6-item alienation subscale (Ritsher et al. 2003) adapted for suicide attempt, 6 items rated from 1-4, we will calculate a mean score accross all items (range: 1-6) with higher scores indicating more self-stigma. | baseline, 6 weeks, 12 weeks | 
| Stigma stress related to suicide attempt | Stigma Stress Scale (Rüsch et al., 2009a,b) adapted for suicide attempt, 8-items rated from 1-7 with 4 items measuring the primary appraisal of stigma as harmful and 4 items measuring the secondary appraisal of perceived resources to cope with stigma-related harm, for each of the two subscales we will calculate a mean score (range 1-7) and a total stigma stress score will be caclulated by subtracting perceived resources from perceived harm with higher difference scores (range -6 to +6) indicating more stigma-stress. | baseline, 2 weeks, 6 weeks, 12 weeks | 
| Secrecy about suicide attempt | Secrecy Scale (Link et al., 1991) adapted for suicide attempt, 5 items rated from 1-6, we will calculate a mean score accross all items (range 1-6) with higher scores indicating more secrecy. | baseline, 2 weeks, 6 weeks, 12 weeks | 
| General disclosure distress | Distress Disclosure Index (Kahn et al., 2001), 12 items rated from 1-5, we will calculate a sum score accross all items (range 12-60) with higher scores indicating more disclosure distress. | baseline, 2 weeks, 6 weeks, 12 weeks | 
| Help-seeking for suicidality | General Help-Seeking Questionnaire - suicidal ideation subscale (GHSQ-SI) (Wilson et al., 2005), 10 items rated from 1-7, we will calculate mean scores (range 1-7) for items related to social contacts (items 1-4) and care providers (items 5,7,10). | baseline, 2 weeks, 6 weeks, 12 weeks | 
| Depressive symptoms | Center for Epidemiological Studies-Depression Scale - short form (CES-D) (Hautzinger et al., 1993), 15 items rated from 0-3, we will calculate a sum score accross all items (range 0-45) with higher scores indicating more depressive symptoms. | baseline, 2 weeks, 6 weeks, 12 weeks | 
| Suicidal ideation | Suicidal Ideation Attributes Scale (SIDAS) (Spijker et al., 2014), 5 items rated from 0-10, we will calculate a total sum score accross all items (range 0-50) with higher scores indicating more suicidality. | baseline, 2 weeks, 6 weeks, 12 weeks | 
| Recovery | Recovery Assessment Scale - short version (RAS-G) (Corrigan et al., 2004), 24 items rated from 1-5, we will calculate a mean score accross all items (range 1-5) with higher scores indicating more recovery. | baseline, 2 weeks, 6 weeks, 12 weeks | 
| Self-esteem | Rosenberg's Self-Esteem Scale (RSE) (Collani et al., 2003), 10 items rated from 0-3, we will caculate a sum score accross all items (range 0-30) with higher scores indicating more self-esteem. | baseline, 2 weeks, 6 weeks, 12 weeks | 
| Quality of life | EUROHIS Quality of Life Index (EUROHIS-QOL) (Brähler et al., 2007), 8 items rated from 1-5, we will calculate a sum score accross all items (range 8-40) with higher scores indicating more quality of life. | baseline, 2 weeks, 6 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stigma, Suicide attempt survivor, Secrecy, Group intervention, Disclosure