- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02505373
ASSIP, Attempted Suicide Short Intervention Program. Two Year Follow-Up Study (ASSIP)
A Novel Brief Therapy for Attempted Suicide: Two Year Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, 3008
- University Hospital of Psychiatry and Psychotherapy, University of Bern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male/female
- Inpatient/outpatient, day care treatment
- German language
- All diagnosis (except: psychosis)
- Written informed consent
Exclusion Criteria
- Psychosis
- Imprisonment
- Foreign languages
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group ASSIP
Intervention Group ASSIP (Brief Therapy)
|
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. |
Active Comparator: Control Group CG
Control Group CG (structured interview)
|
Participants assigned to the control group underwent a single clinical interview that included a structured assessment of suicide using the SSF (Jobes, 2006).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicidal behaviour
Time Frame: 2-year follow-up
|
Measured by socio-demographic & clinical questionnaire
|
2-year follow-up
|
Suicidal behaviour
Time Frame: 1-year follow-up
|
Measured by socio-demographic & clinical questionnaire
|
1-year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contact to health care system
Time Frame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
|
Measured by questionnaire
|
At baseline, after 6 months, after 12 months, after 18 months, after 24 months
|
Suicidal ideation
Time Frame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
|
Measured by Beck Scale for Suicidal Ideation (BSS)
|
At baseline, after 6 months, after 12 months, after 18 months, after 24 months
|
Depression
Time Frame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
|
Measured by Beck Depression Inventory (BDI)
|
At baseline, after 6 months, after 12 months, after 18 months, after 24 months
|
Coping
Time Frame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
|
Measured by Brief COPE
|
At baseline, after 6 months, after 12 months, after 18 months, after 24 months
|
Global distress
Time Frame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
|
Measured by SCL-9
|
At baseline, after 6 months, after 12 months, after 18 months, after 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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
Publications and helpful links
General Publications
- 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.
- Zelen M. A new design for randomized clinical trials. N Engl J Med. 1979 May 31;300(22):1242-5. doi: 10.1056/NEJM197905313002203.
- 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:CD013668. doi: 10.1002/14651858.CD013668.pub2.
- 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.
- 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.
- 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.
- 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.
- Beck, A. T. & Steer, R. A. (1987). BDI, Beck depression inventory: manual. New York, NY: Psychological Corporation.
- Beck, A. T. & Steer, R. A. (1991). Manual for the Beck scale for suicide ideation. San Antonio, TX: Psychological Corporation.
- 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.
- 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.
- 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.
- Gysin-Maillart, A. & Michel, K. (2013). Kurztherapie nach Suizidversuch. ASSIP-Attempted Suicide Short Intervention Program. Therapiemanual. Bern: Huber. ISBN: 9783456852386
- 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.
- Jobes DA. Collaborating to prevent suicide: a clinical-research perspective. Suicide Life Threat Behav. 2000 Spring;30(1):8-17.
- 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
- Michel, K. & Valach, L. (1997). Suicide as goal-directed action. Archives of Suicide Research, 3, 213-221. http://doi.org/10.1080/13811119708258273
- 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.
- 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.
- Michel, K. & Gysin-Maillart, A. (2015). Attempted Suicide Short Intervention Program ASSIP. A manual for clinicians. Göttingen: Hogrefe. ISBN: 978-0-88937-476-8
- 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.
- Rudd MD. The suicidal mode: a cognitive-behavioral model of suicidality. Suicide Life Threat Behav. 2000 Spring;30(1):18-33.
- 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.
- 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
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 144/08
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