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

Study Overview
=================
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.

Official Title
-----------------
A Novel Brief Therapy for Attempted Suicide: Two Year Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP)

Conditions
-----------------
Suicide Attempt, Suicide, Suicidal Ideation

Intervention / Treatment
-----------------
* Behavioral: Attempted Suicide Short Intervention Program (ASSIP)
* Behavioral: Control Group (CG)


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group ASSIP<br>Intervention Group ASSIP (Brief Therapy) | Behavioral: Attempted Suicide Short Intervention Program (ASSIP)<br>* 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.<br>|
| Active Comparator: Control Group CG<br>Control Group CG (structured interview) | Behavioral: Control Group (CG)<br>* Participants assigned to the control group underwent a single clinical interview that included a structured assessment of suicide using the SSF (Jobes, 2006).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact to health care system | Measured by questionnaire | At baseline, after 6 months, after 12 months, after 18 months, after 24 months | 
| Suicidal ideation | Measured by Beck Scale for Suicidal Ideation (BSS) | At baseline, after 6 months, after 12 months, after 18 months, after 24 months | 
| Depression | Measured by Beck Depression Inventory (BDI) | At baseline, after 6 months, after 12 months, after 18 months, after 24 months | 
| Coping | Measured by Brief COPE | At baseline, after 6 months, after 12 months, after 18 months, after 24 months | 
| Global distress | Measured by SCL-9 | At baseline, after 6 months, after 12 months, after 18 months, after 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brief Therapy, Attempted Suicide, Therapeutic Alliance, Suicidal Ideation, Suicide, ASSIP