search
Back to results

ASSIP, Attempted Suicide Short Intervention Program. Two Year Follow-Up Study (ASSIP)

Primary Purpose

Suicide Attempt, Suicide, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Attempted Suicide Short Intervention Program (ASSIP)
Control Group (CG)
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide Attempt focused on measuring Brief Therapy, Attempted Suicide, Therapeutic Alliance, Suicidal Ideation, Suicide, ASSIP

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria

  • Psychosis
  • Imprisonment
  • Foreign languages

Sites / Locations

  • University Hospital of Psychiatry and Psychotherapy, University of Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group ASSIP

Control Group CG

Arm Description

Intervention Group ASSIP (Brief Therapy)

Control Group CG (structured interview)

Outcomes

Primary Outcome Measures

Suicidal behaviour
Measured by socio-demographic & clinical questionnaire
Suicidal behaviour
Measured by socio-demographic & clinical questionnaire

Secondary Outcome Measures

Contact to health care system
Measured by questionnaire
Suicidal ideation
Measured by Beck Scale for Suicidal Ideation (BSS)
Depression
Measured by Beck Depression Inventory (BDI)
Coping
Measured by Brief COPE
Global distress
Measured by SCL-9

Full Information

First Posted
July 16, 2015
Last Updated
January 13, 2016
Sponsor
University of Bern
search

1. Study Identification

Unique Protocol Identification Number
NCT02505373
Brief Title
ASSIP, Attempted Suicide Short Intervention Program. Two Year Follow-Up Study
Acronym
ASSIP
Official Title
A Novel Brief Therapy for Attempted Suicide: Two Year Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background In the prevention and treatment of suicidality the main emphasis according to the traditional medical model has been on diagnosis and treatment of mental disorders, first and foremost depression. However, it is debatable how far this approach toward the suicidal patient can actually affect suicide rates. It has been argued that the mechanisms of suicidal behavior should be studied independently of any associated psychiatric disorder. Follow-up studies strongly suggest that when a person has attempted suicide, the risk of future suicidal behavior, including death by suicide, cannot be "cured". Once a person has tried to solve an emotional crisis with a suicide attempt, this behavioral pattern will quickly re-emerge in similar situations in the future, not only because a suicide attempt provides a - temporary - solution, but also because very often it associated with an immediate sense of relief. The prevailing view emerging from recent developments in suicide research is that, following attempted suicide, it is crucial to establish individual safety strategies with patients for coping differently in future emotional crises. For as many patients as possible to benefit, treatments targeting suicidality should be brief and focused, and, of course, effective. ASSIP combines aspects of action theory, cognitive behavior therapy, and attachment theory. A fundamental assumption is that an action theoretical approach toward the suicidal patient will establish a therapeutic alliance in the sense of a "secure base", which will enhance the effect of the regular letters following the four treatment sessions. ASSIP is not a stand-alone therapy but should be offered to suicidal patients in addition to the usual clinical management and follow-up treatment. Objective How effective is ASSIP, compared to a control group in preventing suicidal behaviour after a suicide attempt? Primary outcome measures: Suicidal behaviour, suicidal ideation Secondary outcome measures: Depression, coping skills, contact to health care system Which parameters have a moderating influence on outcome measures? Therapeutic alliance Diagnosis Previous suicide attempts Methods 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. The quality of the therapeutic alliance as a moderating factor for outcome was measured at the therapy sessions 1 (both groups) and 3 (ASSIP group only) using the Helping Alliance Questionnaire (HAq). Regarding outcome measures the study participants completed a set of psychosocial and clinical questionnaires every 6 months during a 24-months follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Attempt, Suicide, Suicidal Ideation
Keywords
Brief Therapy, Attempted Suicide, Therapeutic Alliance, Suicidal Ideation, Suicide, ASSIP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group ASSIP
Arm Type
Experimental
Arm Description
Intervention Group ASSIP (Brief Therapy)
Arm Title
Control Group CG
Arm Type
Active Comparator
Arm Description
Control Group CG (structured interview)
Intervention Type
Behavioral
Intervention Name(s)
Attempted Suicide Short Intervention Program (ASSIP)
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Control Group (CG)
Intervention Description
Participants assigned to the control group underwent a single clinical interview that included a structured assessment of suicide using the SSF (Jobes, 2006).
Primary Outcome Measure Information:
Title
Suicidal behaviour
Description
Measured by socio-demographic & clinical questionnaire
Time Frame
2-year follow-up
Title
Suicidal behaviour
Description
Measured by socio-demographic & clinical questionnaire
Time Frame
1-year follow-up
Secondary Outcome Measure Information:
Title
Contact to health care system
Description
Measured by questionnaire
Time Frame
At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Title
Suicidal ideation
Description
Measured by Beck Scale for Suicidal Ideation (BSS)
Time Frame
At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Title
Depression
Description
Measured by Beck Depression Inventory (BDI)
Time Frame
At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Title
Coping
Description
Measured by Brief COPE
Time Frame
At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Title
Global distress
Description
Measured by SCL-9
Time Frame
At baseline, after 6 months, after 12 months, after 18 months, after 24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male/female Inpatient/outpatient, day care treatment German language All diagnosis (except: psychosis) Written informed consent Exclusion Criteria Psychosis Imprisonment Foreign languages
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad Michel, Prof.
Organizational Affiliation
Hospital of Psychiatry and Psychotherapy, University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anja C Gysin-Maillart, Ph.D.
Organizational Affiliation
Hospital of Psychiatry and Psychotherapy, University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Psychiatry and Psychotherapy, University of Bern
City
Bern
ZIP/Postal Code
3008
Country
Switzerland

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
PubMed Identifier
11459249
Citation
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.
Results Reference
background
Citation
Beck, A. T. & Steer, R. A. (1987). BDI, Beck depression inventory: manual. New York, NY: Psychological Corporation.
Results Reference
background
Citation
Beck, A. T. & Steer, R. A. (1991). Manual for the Beck scale for suicide ideation. San Antonio, TX: Psychological Corporation.
Results Reference
background
PubMed Identifier
16077050
Citation
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.
Results Reference
background
PubMed Identifier
23520223
Citation
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.
Results Reference
background
PubMed Identifier
24750971
Citation
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.
Results Reference
background
PubMed Identifier
11437747
Citation
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.
Results Reference
background
Citation
Gysin-Maillart, A. & Michel, K. (2013). Kurztherapie nach Suizidversuch. ASSIP-Attempted Suicide Short Intervention Program. Therapiemanual. Bern: Huber. ISBN: 9783456852386
Results Reference
background
PubMed Identifier
19792981
Citation
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.
Results Reference
background
PubMed Identifier
10782715
Citation
Jobes DA. Collaborating to prevent suicide: a clinical-research perspective. Suicide Life Threat Behav. 2000 Spring;30(1):8-17.
Results Reference
background
Citation
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
Results Reference
background
Citation
Michel, K. & Valach, L. (1997). Suicide as goal-directed action. Archives of Suicide Research, 3, 213-221. http://doi.org/10.1080/13811119708258273
Results Reference
background
PubMed Identifier
16081387
Citation
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.
Results Reference
background
PubMed Identifier
12400207
Citation
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.
Results Reference
background
Citation
Michel, K. & Gysin-Maillart, A. (2015). Attempted Suicide Short Intervention Program ASSIP. A manual for clinicians. Göttingen: Hogrefe. ISBN: 978-0-88937-476-8
Results Reference
background
PubMed Identifier
11376235
Citation
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.
Results Reference
background
PubMed Identifier
25677353
Citation
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.
Results Reference
background
PubMed Identifier
10782716
Citation
Rudd MD. The suicidal mode: a cognitive-behavioral model of suicidality. Suicide Life Threat Behav. 2000 Spring;30(1):18-33.
Results Reference
background
PubMed Identifier
17579539
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
431682
Citation
Zelen M. A new design for randomized clinical trials. N Engl J Med. 1979 May 31;300(22):1242-5. doi: 10.1056/NEJM197905313002203.
Results Reference
background
PubMed Identifier
33884617
Citation
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.
Results Reference
derived
PubMed Identifier
32880104
Citation
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.
Results Reference
derived
PubMed Identifier
30646253
Citation
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.
Results Reference
derived
PubMed Identifier
26930055
Citation
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.
Results Reference
derived

Learn more about this trial

ASSIP, Attempted Suicide Short Intervention Program. Two Year Follow-Up Study

We'll reach out to this number within 24 hrs