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