To Share Or Not To Share

History of Suicide Attempt Clinical Trial

— 2Share  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03943862
• Other study ID #: 345/18
• Status: Terminated
• Phase: Phase 2
• Start date: May 7, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• History of Suicide Attempt
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• 2Share
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.

Locations

Country	Name	City	State
Germany	University of Ulm and BKH Günzburg	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (12)

Brähler E, Mühlan H, Albani C, Schmidt S. Teststatistische Prüfung und Normierung der deutschen Versionen des EUROHIS-QOL Lebensqualität-Index und des WHO-5 Wohlbefindens-Index [Psychometrics and standardization of the German version of EUROHIS-QOL quality of life index and WHO-5 wellbeing index]. Diagnostica. 2007;53(2):83-96. doi:10.1026/0012-1924.53.2.83

Collani G v., Herzberg PY. Eine revidierte Fassung der deutschsprachigen Skala zum Selbstwertgefühl von Rosenberg [A revision of the German Rosenbergs self-esteem scale]. Zeitschrift für Differentielle und Diagnostische Psychologie. 2003;24(1):3-7. doi:10.1024//0170-1789.24.1.3

Corrigan PW, Salzer M, Ralph RO, Sangster Y, Keck L. Examining the factor structure of the recovery assessment scale. Schizophr Bull. 2004;30(4):1035-41. — View Citation

Hautzinger M, Bailer M. Allgemeine Depressions-Skala [The German version of the Center for Epidemiological Studies-Depression scale]. Weinheim: Beltz; 1993.

Kahn JH, Hessling RM. Measuring the tendency to conceal versus disclose psychological distress. J Soc Clin Psychol. 2001;20(1):41-65. doi:10.1521/jscp.20.1.41.22254

Link BG, Mirotznik J, Cullen FT. The effectiveness of stigma coping orientations: can negative consequences of mental illness labeling be avoided? J Health Soc Behav. 1991 Sep;32(3):302-20. — View Citation

Ritsher JB, Otilingam PG, Grajales M. Internalized stigma of mental illness: psychometric properties of a new measure. Psychiatry Res. 2003 Nov 1;121(1):31-49. — View Citation

Rüsch N, Corrigan PW, Powell K, Rajah A, Olschewski M, Wilkniss S, Batia K. A stress-coping model of mental illness stigma: II. Emotional stress responses, coping behavior and outcome. Schizophr Res. 2009 May;110(1-3):65-71. doi: 10.1016/j.schres.2009.01.005. Epub 2009 Feb 23. — View Citation

Rüsch N, Corrigan PW, Wassel A, Michaels P, Olschewski M, Wilkniss S, Batia K. A stress-coping model of mental illness stigma: I. Predictors of cognitive stress appraisal. Schizophr Res. 2009 May;110(1-3):59-64. doi: 10.1016/j.schres.2009.01.006. Epub 2009 Mar 6. — View Citation

Sheehan L, Oexle N, Dubke R, Ting Wan H, Corrigan PW. The Self-Stigma of Suicide Attempt Survivors. Arch Suicide Res. 2018 Aug 24:1-25. doi: 10.1080/13811118.2018.1510797. [Epub ahead of print] — View Citation

van Spijker BA, Batterham PJ, Calear AL, Farrer L, Christensen H, Reynolds J, Kerkhof AJ. The suicidal ideation attributes scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide Life Threat Behav. 2014 Aug;44(4):408-19. doi: 10.1111/sltb.12084. Epub 2014 Feb 24. — View Citation

Wilson CJ, Deane FP, Ciarrochi JV, Rickwood D. Measuring help seeking intentions: properties of the General Help Seeking Questionnaire. Canadian Journal of Counselling. 2005;39(1):15-28. doi:10.1080/09638237.2017.1370642.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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