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To Share Or Not To Share (2Share)

11. mars 2020 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

4

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyskland
      • Ulm, Tyskland, 89073
        • University of Ulm and BKH Günzburg

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Ingen inngripen: Treatment as usual
Participants randomized to the control group do not receive the group program but maintain their current treatment (treatment as usual).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-stigma related to suicide attempt
Tidsramme: 2 weeks
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-stigma related to suicide attempt
Tidsramme: baseline, 6 weeks, 12 weeks
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
Tidsramme: baseline, 6 weeks, 12 weeks
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
Tidsramme: baseline, 2 weeks, 6 weeks, 12 weeks
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
Tidsramme: baseline, 2 weeks, 6 weeks, 12 weeks
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
Tidsramme: baseline, 2 weeks, 6 weeks, 12 weeks
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
Tidsramme: baseline, 2 weeks, 6 weeks, 12 weeks
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
Tidsramme: baseline, 2 weeks, 6 weeks, 12 weeks
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
Tidsramme: baseline, 2 weeks, 6 weeks, 12 weeks
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
Tidsramme: baseline, 2 weeks, 6 weeks, 12 weeks
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
Tidsramme: baseline, 2 weeks, 6 weeks, 12 weeks
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
Tidsramme: baseline, 2 weeks, 6 weeks, 12 weeks
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

Samarbeidspartnere og etterforskere

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Sponsor

University of Ulm

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

7. mai 2019

Primær fullføring (Faktiske)

1. januar 2020

Studiet fullført (Faktiske)

1. mars 2020

Datoer for studieregistrering

Først innsendt

7. mai 2019

Først innsendt som oppfylte QC-kriteriene

7. mai 2019

Først lagt ut (Faktiske)

9. mai 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mars 2020

Sist bekreftet

1. mars 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 345/18

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NEI

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