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To Share Or Not To Share (2Share)

Primary Purpose

History of Suicide Attempt

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
2Share
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for History of Suicide Attempt focused on measuring Stigma, Suicide attempt survivor, Secrecy, Group intervention, Disclosure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Ulm and BKH Günzburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention (2Share) + treatment as usual

Treatment as usual

Arm Description

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.

Participants randomized to the control group do not receive the group program but maintain their current treatment (treatment as usual).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.

Full Information

First Posted
May 7, 2019
Last Updated
March 11, 2020
Sponsor
University of Ulm
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1. Study Identification

Unique Protocol Identification Number
NCT03943862
Brief Title
To Share Or Not To Share
Acronym
2Share
Official Title
To Share or Not To Share (2Share) - Group Intervention to Support Disclosure Decisions After Suicide Attempt
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to a small number of study participants.
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
History of Suicide Attempt
Keywords
Stigma, Suicide attempt survivor, Secrecy, Group intervention, Disclosure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention (2Share) + treatment as usual
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Participants randomized to the control group do not receive the group program but maintain their current treatment (treatment as usual).
Intervention Type
Behavioral
Intervention Name(s)
2Share
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-stigma related to suicide attempt
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Self-stigma related to suicide attempt
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks
Title
Self-Stigma (alienation) related to suicide attempt
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks
Title
Stigma stress related to suicide attempt
Description
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.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
Secrecy about suicide attempt
Description
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.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
General disclosure distress
Description
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.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
Help-seeking for suicidality
Description
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).
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
Depressive symptoms
Description
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.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
Suicidal ideation
Description
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.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
Recovery
Description
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.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
Self-esteem
Description
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.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
Quality of life
Description
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.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Ulm and BKH Günzburg
City
Ulm
ZIP/Postal Code
89073
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30142296
Citation
Sheehan L, Oexle N, Dubke R, Wan HT, Corrigan PW. The Self-Stigma of Suicide Attempt Survivors. Arch Suicide Res. 2020 Jan-Mar;24(1):34-47. doi: 10.1080/13811118.2018.1510797. Epub 2018 Dec 1.
Results Reference
background
PubMed Identifier
19237266
Citation
Rusch 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.
Results Reference
background
PubMed Identifier
19269140
Citation
Rusch 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.
Results Reference
background
PubMed Identifier
1940212
Citation
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.
Results Reference
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Citation
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
Results Reference
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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.
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Hautzinger M, Bailer M. Allgemeine Depressions-Skala [The German version of the Center for Epidemiological Studies-Depression scale]. Weinheim: Beltz; 1993.
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PubMed Identifier
24612048
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.
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PubMed Identifier
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Citation
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. doi: 10.1093/oxfordjournals.schbul.a007118.
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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
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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
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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. doi: 10.1016/j.psychres.2003.08.008.
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Results Reference
derived

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To Share Or Not To Share

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