To Share Or Not To Share (2Share)

March 11, 2020 updated by: 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.

Study Overview

Status

Terminated

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:

  • 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.
No Intervention: Treatment as usual
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-stigma related to suicide attempt
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-stigma related to suicide attempt
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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