Clinical trial NCT02505373: ASSIP, Attempted Suicide Short Intervention Program. Two Year Follow-Up Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Suicide Attempt
Suicide
Suicidal Ideation
Keywords: Brief Therapy
Attempted Suicide
Therapeutic Alliance
Suicidal Ideation
Suicide
ASSIP
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Suicidal behaviour
timeFrame: 2-year follow-up
measure: Suicidal behaviour
timeFrame: 1-year follow-up
Secondary outcomes:
measure: Contact to health care system
timeFrame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
measure: Suicidal ideation
timeFrame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
measure: Depression
timeFrame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
measure: Coping
timeFrame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
measure: Global distress
timeFrame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Psychiatry and Psychotherapy, University of Bern
Study officials:
affiliation: Hospital of Psychiatry and Psychotherapy, University of Bern
name: Konrad Michel, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital of Psychiatry and Psychotherapy, University of Bern
name: Anja C Gysin-Maillart, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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