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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02505373
Other study ID # 144/08
Secondary ID
Status Completed
Phase N/A
First received July 16, 2015
Last updated January 13, 2016
Start date January 2009
Est. completion date June 2014

Study information

Verified date January 2016
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.


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

1. How effective is ASSIP, compared to a control group in preventing suicidal behaviour after a suicide attempt?

1. Primary outcome measures: Suicidal behaviour, suicidal ideation

2. Secondary outcome measures: Depression, coping skills, contact to health care system

2. Which parameters have a moderating influence on outcome measures?

1. Therapeutic alliance

2. Diagnosis

3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Behavioral:
Attempted Suicide Short Intervention Program (ASSIP)
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.
Control Group (CG)
Participants assigned to the control group underwent a single clinical interview that included a structured assessment of suicide using the SSF (Jobes, 2006).

Locations

Country Name City State
Switzerland University Hospital of Psychiatry and Psychotherapy, University of Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (22)

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, Träskman-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. — View Citation

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.

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. — View 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. — View 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. — View 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. — View Citation

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. Review. — View Citation

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

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

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

Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33. — View 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. — View Citation

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

Zelen M. A new design for randomized clinical trials. N Engl J Med. 1979 May 31;300(22):1242-5. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Suicidal behaviour Measured by socio-demographic & clinical questionnaire 2-year follow-up No
Primary Suicidal behaviour Measured by socio-demographic & clinical questionnaire 1-year follow-up No
Secondary Contact to health care system Measured by questionnaire At baseline, after 6 months, after 12 months, after 18 months, after 24 months No
Secondary Suicidal ideation Measured by Beck Scale for Suicidal Ideation (BSS) At baseline, after 6 months, after 12 months, after 18 months, after 24 months No
Secondary Depression Measured by Beck Depression Inventory (BDI) At baseline, after 6 months, after 12 months, after 18 months, after 24 months No
Secondary Coping Measured by Brief COPE At baseline, after 6 months, after 12 months, after 18 months, after 24 months No
Secondary Global distress Measured by SCL-9 At baseline, after 6 months, after 12 months, after 18 months, after 24 months No
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