NCT02505373

Brief Summary

Objective Attempted suicide is the main risk factor for repeated suicidal behavior. However, evidence of the effectiveness of follow-up treatments for these patients is limited. The authors evaluated the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a novel brief therapy based on a patient-oriented model of suicidal behavior. The ASSIP consists of three sessions followed by regular letters for 24 months. Method In this treatment study, 120 patients were randomly assigned to either the ASSIP intervention or a control group that received a one-session clinical assessment. Both groups received in- and outpatient treatment as usual. Study participants also completed a set of psychosocial and clinical questionnaires every 6 months during a 24-month follow-up period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

5.4 years

First QC Date

July 16, 2015

Last Update Submit

January 13, 2016

Conditions

Keywords

Brief TherapyAttempted SuicideTherapeutic AllianceSuicidal IdeationSuicideASSIP

Outcome Measures

Primary Outcomes (2)

  • Suicidal behaviour

    Measured by socio-demographic \& clinical questionnaire

    2-year follow-up

  • Suicidal behaviour

    Measured by socio-demographic \& clinical questionnaire

    1-year follow-up

Secondary Outcomes (5)

  • Contact to health care system

    At baseline, after 6 months, after 12 months, after 18 months, after 24 months

  • Suicidal ideation

    At baseline, after 6 months, after 12 months, after 18 months, after 24 months

  • Depression

    At baseline, after 6 months, after 12 months, after 18 months, after 24 months

  • Coping

    At baseline, after 6 months, after 12 months, after 18 months, after 24 months

  • Global distress

    At baseline, after 6 months, after 12 months, after 18 months, after 24 months

Study Arms (2)

Intervention Group ASSIP

EXPERIMENTAL

Intervention Group ASSIP (Brief Therapy)

Behavioral: Attempted Suicide Short Intervention Program (ASSIP)

Control Group CG

ACTIVE COMPARATOR

Control Group CG (structured interview)

Behavioral: Control Group (CG)

Interventions

The brief therapy ASSIP consists of three to four sessions, which are ideally administered within a period of 2 to 4 weeks. Therapy sessions are scheduled for 60 to 90 minutes. Session 1: A narrative interview is conducted, in which the patient is asked to tell his or her personal story which led to the suicidal crisis. The narrative is video-recorded. Session 2: Using video-playback of the recorded narrative, patient and therapist explore further details of the suicidal process. Session 3: A case conceptualization focusing on the patient's vulnerability and the trigger of the suicidal crisis is formulated in writing. A list of safety strategies for the prevention of future suicidal behaviour is developed jointly with the patient. Regular letters are sent to patients over a period of 2 years.

Intervention Group ASSIP

Participants assigned to the control group underwent a single clinical interview that included a structured assessment of suicide using the SSF (Jobes, 2006).

Control Group CG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male/female
  • Inpatient/outpatient, day care treatment
  • German language
  • All diagnosis (except: psychosis)
  • Written informed consent

You may not qualify if:

  • Psychosis
  • Imprisonment
  • Foreign languages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Psychiatry and Psychotherapy, University of Bern

Bern, Canton of Bern, 3008, Switzerland

Location

Related Publications (26)

  • Alexander, L. B. & Luborsky, L. (1986).The Penn Helping Alliance Scales. In L. S. Greenberg & W. M. Pinsoff (Eds.), The psychotherapeutic process: A research handbook (pp. 325-366). New York, NY: Guilford Press.

    BACKGROUND
  • Arensman E, Townsend E, Hawton K, Bremner S, Feldman E, Goldney R, Gunnell D, Hazell P, Van Heeringen K, House A, Owens D, Sakinofsky I, Traskman-Bendz L. Psychosocial and pharmacological treatment of patients following deliberate self-harm: the methodological issues involved in evaluating effectiveness. Suicide Life Threat Behav. 2001 Summer;31(2):169-80. doi: 10.1521/suli.31.2.169.21516.

    PMID: 11459249BACKGROUND
  • Beck, A. T. & Steer, R. A. (1987). BDI, Beck depression inventory: manual. New York, NY: Psychological Corporation.

    BACKGROUND
  • Beck, A. T. & Steer, R. A. (1991). Manual for the Beck scale for suicide ideation. San Antonio, TX: Psychological Corporation.

    BACKGROUND
  • Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.

    PMID: 16077050BACKGROUND
  • Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge: 5-year outcomes of a randomised controlled trial for hospital-treated self-poisoning. Br J Psychiatry. 2013 May;202(5):372-80. doi: 10.1192/bjp.bp.112.112664. Epub 2013 Mar 21.

    PMID: 23520223BACKGROUND
  • Claassen CA, Pearson JL, Khodyakov D, Satow PM, Gebbia R, Berman AL, Reidenberg DJ, Feldman S, Molock S, Carras MC, Lento RM, Sherrill J, Pringle B, Dalal S, Insel TR. Reducing the burden of suicide in the U.S.: the aspirational research goals of the National Action Alliance for Suicide Prevention Research Prioritization Task Force. Am J Prev Med. 2014 Sep;47(3):309-14. doi: 10.1016/j.amepre.2014.01.004. Epub 2014 Apr 18.

    PMID: 24750971BACKGROUND
  • Granboulan V, Roudot-Thoraval F, Lemerle S, Alvin P. Predictive factors of post-discharge follow-up care among adolescent suicide attempters. Acta Psychiatr Scand. 2001 Jul;104(1):31-6. doi: 10.1034/j.1600-0447.2001.00297.x.

    PMID: 11437747BACKGROUND
  • Gysin-Maillart, A. & Michel, K. (2013). Kurztherapie nach Suizidversuch. ASSIP-Attempted Suicide Short Intervention Program. Therapiemanual. Bern: Huber. ISBN: 9783456852386

    BACKGROUND
  • Hatcher S, Sharon C, Coggan C. Beyond randomized controlled trials in attempted suicide research. Suicide Life Threat Behav. 2009 Aug;39(4):396-407. doi: 10.1521/suli.2009.39.4.396.

    PMID: 19792981BACKGROUND
  • Jobes DA. Collaborating to prevent suicide: a clinical-research perspective. Suicide Life Threat Behav. 2000 Spring;30(1):8-17.

    PMID: 10782715BACKGROUND
  • Monti, K., Cedereke, M. & Ojehagen, A. (2003). Treatment attendance and suicidal behavior 1 month and 3 months after a suicide attempt: A comparison between two samples. Archives of Suicide Research, 7, 167-174. http://doi.org/10.1080/13811110301581

    BACKGROUND
  • Michel, K. & Valach, L. (1997). Suicide as goal-directed action. Archives of Suicide Research, 3, 213-221. http://doi.org/10.1080/13811119708258273

    BACKGROUND
  • Michel K, Dey P, Stadler K, Valach L. Therapist sensitivity towards emotional life-career issues and the working alliance with suicide attempters. Arch Suicide Res. 2004;8(3):203-13. doi: 10.1080/13811110490436792.

    PMID: 16081387BACKGROUND
  • Michel K, Maltsberger JT, Jobes DA, Leenaars AA, Orbach I, Stadler K, Dey P, Young RA, Valach L. Discovering the truth in attempted suicide. Am J Psychother. 2002;56(3):424-37. doi: 10.1176/appi.psychotherapy.2002.56.3.424.

    PMID: 12400207BACKGROUND
  • Michel, K. & Gysin-Maillart, A. (2015). Attempted Suicide Short Intervention Program ASSIP. A manual for clinicians. Göttingen: Hogrefe. ISBN: 978-0-88937-476-8

    BACKGROUND
  • Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33. doi: 10.1176/appi.ps.52.6.828.

    PMID: 11376235BACKGROUND
  • Rudd MD, Bryan CJ, Wertenberger EG, Peterson AL, Young-McCaughan S, Mintz J, Williams SR, Arne KA, Breitbach J, Delano K, Wilkinson E, Bruce TO. Brief cognitive-behavioral therapy effects on post-treatment suicide attempts in a military sample: results of a randomized clinical trial with 2-year follow-up. Am J Psychiatry. 2015 May;172(5):441-9. doi: 10.1176/appi.ajp.2014.14070843. Epub 2015 Feb 13.

    PMID: 25677353BACKGROUND
  • Rudd MD. The suicidal mode: a cognitive-behavioral model of suicidality. Suicide Life Threat Behav. 2000 Spring;30(1):18-33.

    PMID: 10782716BACKGROUND
  • Silverman MM, Berman AL, Sanddal ND, O'carroll PW, Joiner TE. Rebuilding the tower of Babel: a revised nomenclature for the study of suicide and suicidal behaviors. Part 2: Suicide-related ideations, communications, and behaviors. Suicide Life Threat Behav. 2007 Jun;37(3):264-77. doi: 10.1521/suli.2007.37.3.264. No abstract available.

    PMID: 17579539BACKGROUND
  • Stanley, B. & Brown, G. K. (2012). Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice, 19, 256-264. http://doi.org/10.1016/j.cbpra.2011.01.001

    BACKGROUND
  • Zelen M. A new design for randomized clinical trials. N Engl J Med. 1979 May 31;300(22):1242-5. doi: 10.1056/NEJM197905313002203.

    PMID: 431682BACKGROUND
  • 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.

  • Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.

  • Park AL, Gysin-Maillart A, Muller TJ, Exadaktylos A, Michel K. Cost-effectiveness of a Brief Structured Intervention Program Aimed at Preventing Repeat Suicide Attempts Among Those Who Previously Attempted Suicide: A Secondary Analysis of the ASSIP Randomized Clinical Trial. JAMA Netw Open. 2018 Oct 5;1(6):e183680. doi: 10.1001/jamanetworkopen.2018.3680.

  • Gysin-Maillart A, Schwab S, Soravia L, Megert M, Michel K. A Novel Brief Therapy for Patients Who Attempt Suicide: A 24-months Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP). PLoS Med. 2016 Mar 1;13(3):e1001968. doi: 10.1371/journal.pmed.1001968. eCollection 2016 Mar.

MeSH Terms

Conditions

Suicide, AttemptedSuicideSuicidal Ideation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Konrad Michel, Prof.

    Hospital of Psychiatry and Psychotherapy, University of Bern

    PRINCIPAL INVESTIGATOR
  • Anja C Gysin-Maillart, Ph.D.

    Hospital of Psychiatry and Psychotherapy, University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 22, 2015

Study Start

January 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations