To Share Or Not To Share (2Share)
11. März 2020 aktualisiert von: Nathalie Oexle, University of Ulm
To Share or Not To Share (2Share) - Group Intervention to Support Disclosure Decisions After Suicide Attempt
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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
4
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
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Ulm, Deutschland, 89073
- University of Ulm and BKH Günzburg
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Intervention (2Share) + treatment as usual
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. |
The peer-led group program contains of three lessons plus one booster session:
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Kein Eingriff: Treatment as usual
Participants randomized to the control group do not receive the group program but maintain their current treatment (treatment as usual).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Self-stigma related to suicide attempt
Zeitfenster: 2 weeks
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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.
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2 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Self-stigma related to suicide attempt
Zeitfenster: baseline, 6 weeks, 12 weeks
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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.
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baseline, 6 weeks, 12 weeks
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Self-Stigma (alienation) related to suicide attempt
Zeitfenster: baseline, 6 weeks, 12 weeks
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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.
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baseline, 6 weeks, 12 weeks
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Stigma stress related to suicide attempt
Zeitfenster: baseline, 2 weeks, 6 weeks, 12 weeks
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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.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Secrecy about suicide attempt
Zeitfenster: baseline, 2 weeks, 6 weeks, 12 weeks
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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.
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baseline, 2 weeks, 6 weeks, 12 weeks
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General disclosure distress
Zeitfenster: baseline, 2 weeks, 6 weeks, 12 weeks
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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.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Help-seeking for suicidality
Zeitfenster: baseline, 2 weeks, 6 weeks, 12 weeks
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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).
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baseline, 2 weeks, 6 weeks, 12 weeks
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Depressive symptoms
Zeitfenster: baseline, 2 weeks, 6 weeks, 12 weeks
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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.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Suicidal ideation
Zeitfenster: baseline, 2 weeks, 6 weeks, 12 weeks
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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.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Recovery
Zeitfenster: baseline, 2 weeks, 6 weeks, 12 weeks
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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.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Self-esteem
Zeitfenster: baseline, 2 weeks, 6 weeks, 12 weeks
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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.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Quality of life
Zeitfenster: baseline, 2 weeks, 6 weeks, 12 weeks
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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.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
- Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- Hautzinger M, Bailer M. Allgemeine Depressions-Skala [The German version of the Center for Epidemiological Studies-Depression scale]. Weinheim: Beltz; 1993.
- 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.
- 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
- 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
Studienaufzeichnungsdaten
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Haupttermine studieren
Studienbeginn (Tatsächlich)
7. Mai 2019
Primärer Abschluss (Tatsächlich)
1. Januar 2020
Studienabschluss (Tatsächlich)
1. März 2020
Studienanmeldedaten
Zuerst eingereicht
7. Mai 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. Mai 2019
Zuerst gepostet (Tatsächlich)
9. Mai 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. März 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. März 2020
Zuletzt verifiziert
1. März 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 345/18
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